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1.  Embracing failure: What the Phase III progesterone studies can teach about TBI clinical trials 
Brain Injury  2015;29(11):1259-1272.
Abstract
Background: Despite positive preclinical studies and two positive Phase II clinical trials, two large Phase III clinical trials of progesterone treatment of acute traumatic brain injury (TBI) recently ended with negative results, so a 100% failure rate continues to plague the field of TBI trials.
Methods: This paper reviews and analyses the trial structures and outcomes and discusses the implications of these failures for future drug and clinical trial development. Persistently negative trial outcomes have led to disinvestment in new drug research by companies and policy-makers and disappointment for patients and their families, failures which represent a major public health concern. The problem is not limited to TBI. Failure rates are high for trials in stroke, sepsis, cardiology, cancer and orthopaedics, among others.
Results: This paper discusses some of the reasons why the Phase III trials have failed. These reasons may include faulty extrapolation from pre-clinical data in designing clinical trials and the use of subjective outcome measures that accurately reflect neither the nature of the deficits nor long-term quantitative recovery.
Conclusions: Better definitions of injury and healing and better outcome measures are essential to change the embrace of failure that has dominated the field for over 30 years. This review offers suggestions to improve the situation.
doi:10.3109/02699052.2015.1065344
PMCID: PMC4667711  PMID: 26274493
Clinical trials; progesterone; ProTECT III; SyNAPSe; traumatic brain injury
2.  Safety of human papillomavirus vaccines: a review 
Expert Opinion on Drug Safety  2015;14(5):697-712.
Introduction: Between 2006 and 2009, two different human papillomavirus virus (HPV) vaccines were licensed for use: a quadrivalent (qHPVv) and a bivalent (bHPVv) vaccine. Since 2008, HPV vaccination programmes have been implemented in the majority of the industrialized countries. Since 2013, HPV vaccination has been part of the national programs of 66 countries including almost all countries in North America and Western Europe. Despite all the efforts made by individual countries, coverage rates are lower than expected. Vaccine safety represents one of the main concerns associated with the lack of acceptance of HPV vaccination both in the European Union/European Economic Area and elsewhere.
Areas covered: Safety data published on bivalent and quadrivalent HPV vaccines, both in pre-licensure and post-licensure phase, are reviewed.
Expert opinion: Based on the latest scientific evidence, both HPV vaccines seem to be safe. Nevertheless, public concern and rumors about adverse events (AE) represent an important barrier to overcome in order to increase vaccine coverage. Passive surveillance of AEs is an important tool for detecting safety signals, but it should be complemented by activities aimed at assessing the real cause of all suspect AEs. Improved vaccine safety surveillance is the first step for effective communication based on scientific evidence.
doi:10.1517/14740338.2015.1013532
PMCID: PMC4667712  PMID: 25689872
adverse events; human papillomavirus; safety; vaccine
3.  Bioavailability study of calcium sandoz-250 by atomic absorption spectroscopy in albino rats 
Ayu  2014;35(4):438-441.
Background:
Calcium sandoz-250 is an Ayurvedic calcium supplement, containing Khatika Churna. Bioavailability study of the formulation is essential for estimation of peak plasma concentration (Cmax), time to Cmax and rate of absorption.
Aim:
To evaluate the absorption parameters of calcium sandoz-250 in albino rats by atomic absorption spectroscopic (AAS) method.
Materials and Methods:
Study was carried out as a single dose, open-label, randomized study. Estimation of calcium was carried out by AAS, after validating the method for a few parameters for the estimation. Pharmacokinetic parameters such as Cmax, time to peak concentration (Tmax), area under the plasma concentration - time curve were calculated for calcium on administration of calcium sandoz-250.
Results:
Linearity curve was plotted for 0.5-2.5 ppm, given R2 value 0.9975. The Cmax, i.e. Cmax after administration of calcium sandoz-250 was 0.793 mg/ml at 90 min (Tmax). Measurable calcium-blood levels were noticed in all subjects up to 3.0 h after administration of calcium sandoz-250.
Conclusion:
Calcium sandoz-250, consisting of Khatika Churna, increases the blood calcium level in albino rats.
doi:10.4103/0974-8520.159020
PMCID: PMC4492031  PMID: 26195909
Ayurvedic formulation; bioavailability study; calcium sandoz-250
4.  Exploring insights towards definition and laws of health in Ayurveda: Global health perspective 
Ayu  2014;35(4):351-355.
The current healthcare system is focused on disease management. Our current approach to treatment begins only after the diagnosis, and then attempts to treat the symptoms and prevent the progression. Despite increased global healthcare spending, there has been an increasing incidence, and severity of diseases pointing to impaired health of the populace. This progressive deterioration in general health has created an unsustainable increase in healthcare costs that has hampered the economy. Much of the rising costs in healthcare are secondary to treating the progression of preventable diseases and focus on creating new treatments. There has been an ongoing discussion of incorporating a “defense” or prevention as part of our health system. However, there are few established guidelines beyond tactical use of vaccination in known infectious diseases and screening for chronic diseases and cancers. Ayurveda has the core competency and strategy for prevention of disease. Sushruta has propounded the laws of health, which are unknown to the current healthcare system. This article describes these laws and strategic combination of Ayurveda (defense) and modern medicine (offense) to create a complete healthcare system. This system is called Symbiohealth and is potentially more effective, less expensive, less toxic and creates a healthier society.
doi:10.4103/0974-8520.158975
PMCID: PMC4492016  PMID: 26195894
Allopathy; Ayurveda; disease; health; healthcare; prevention; Symbiohealth
5.  Pharmacognostical and high performance thin layer chromatography studies on leaves of Clerodendrum infortunatum L. 
Ayu  2014;35(4):416-422.
Background:
Clerodendrum infortunatum L. commonly known as Bhant plays a significant role in Indian System of Medicine, that is, Ayurveda, due to its medicinal properties. It grows easily in waste places of all areas of India, Bangladesh, and Myanmar.
Aim:
The present study was carried out with a view to lay down its pharmacognostic standards along with high-performance thin layer chromatography (HPTLC) studies in order to document/validate its therapeutic benefits.
Materials and Methods:
In this research, leaves of C. infortunatum were subjected to pharmacognostic evaluation parameters such as macroscopy, quantitative microscopy, physicochemical studies, phytochemical screening. HPTLC has been developed for detection and quantification of gallic acid and tyrosine in C. infortunatum. Increasing serial dilutions of reference standard gallic acid (20–100 μg/mL) and tyrosine (20–100 μg/mL) were scanned at 254 nm and 280 nm, respectively.
Results:
Microscopy of leaf revealed the presence of anisocytic stomata, sclereids, glandular and covering trichome, and prisms of calcium oxalate crystal. The total ash, water-soluble, and acid insoluble ash values of leaves were 9.95%, 2.15%, and 0.70%, respectively. The maximum extractive value of crude powder was in the water. HPTLC studies revealed that the amount of gallic acid in the crude powder of test sample were high (0.244 mg/g) in comparison to tyrosine (0.081 mg/g).
Conclusion:
The data generated would be of significant use for the authentication of drug and would also serve as a reference for the standardization and quality control of C. infortunatum.
doi:10.4103/0974-8520.159009
PMCID: PMC4492027  PMID: 26195905
Bhant; Clerodendrum infortunatum L.; ethnomedicine; pharmacognostic evaluation; standardization
6.  Antioxidant potential and its relationship with polyphenol content and degree of polymerization in Opuntia elatior Mill. fruits 
Ayu  2014;35(4):423-427.
Background:
Opuntia elatior Mill. (Nagaphani) fruits are traditionally recommended as an expectorant, remedy for whooping cough, asthma, gonorrhea, ulcers, tumors, in the treatment of diarrhea and syphilis. Many of these diseases are allied with oxidative stress caused by free radicals. Thus, current research is directed towards finding naturally-occurring antioxidants of plant origin.
Aim:
To evaluate antioxidant potential of hydro-alcoholic extract of the O. elatior fruits (HAOE) and its fractions.
Materials and Methods:
Using 1,1-diphenyl-2-picrylhydrazyl (DPPH) and nitric oxide radical scavenging assay, total polyphenolic, flavonoid (FA), flavanone (FO) contents and degree of polymerization in relation with its antioxidant activity were examined.
Results:
The experimental data indicated that the HAOE, ethyl acetate (EAOE) and butanol (BFOE) soluble fractions have shown significant antioxidant activity. The highest polyphenolic, FA, FO contents and degree of polymerization were found in EAOE. The scavenging potential was in the order of Ascorbic Acid > EAOE > BFOE > HAOE > BIOE, where ascorbic acid was used as a positive control. The increased antioxidant potential of EAOE and BFOE fractions over HAOE extract may be attributed to the purification achieved by fractionation of the extract which in turn resulted in an increase in the degree of polymerization and segregation of secondary metabolites.
Conclusion:
The fruit of O. elatior can be used as the best alternative for synthetic antioxidants.
doi:10.4103/0974-8520.159010
PMCID: PMC4492028  PMID: 26195906
Antioxidant activity; flavanone; flavonoid; Opuntia elatior; polymerization
7.  Standard manufacturing procedure of Shadguna Balijarita Makaradhwaja 
Ayu  2014;35(4):428-432.
Background:
Makaradhwaja is one of the most potent herbomineral medicines of Ayurveda. Different references for the preparation of Makaradhwaja were reported in classics. According to the proportion of sulfur (Gandhaka), three references were mentioned in classics that is, Dwiguna (2:1 = S: Hg), Triguna (3:1 = S: Hg) and Shadguna (6:1 = S: Hg). Makaradhwaja is prepared by Kupipakwa system of heating. In the preparation of Kupipakwa medicine as the ratio of sulfur to mercury increases it becomes difficult to prepare medicine.
Aim:
To standardize manufacturing procedure of Shadguna Balijarita Makaradhwaja (SBM).
Materials and Methods:
Total four batches of SBM were prepared by using electrical muffle furnace (EMF). All the involved procedures were followed as per classical guidelines.
Results:
Average 13.68% yield of SBM was observed.
Conclusion:
SBM requires intermittent heating pattern, that is, mild heat (100-125° C) for 2.5 hrs, moderate heat (250-450° C) for 4.5 hrs and strong heat (450-600° C) for 5 hrs for 290.5 g Kajjali.
doi:10.4103/0974-8520.159011
PMCID: PMC4492029  PMID: 26195907
Kupipakwa Rasayana; mercury sulfide; Shadguna Balijarita Makaradhwaja
8.  Evaluation of acute toxicity and anti-ulcerogenic study of rhizome starch of two source plants of Tugaksheeree (Curcuma angustifolia Roxb. and Maranta arundinacea Linn.) 
Ayu  2014;35(4):433-437.
Background:
Disorders like hyperacidity and gastric ulcers are found very frequently now days because of a faulty lifestyle. Starches (Satwa) obtained from the rhizomes of two plants namely, Curcuma angustifolia Roxb. (Fam. Zingiberaceae) and Maranta arundinacea Linn. (Fam. Marantaceae) are used in folklore practice, as Tugaksheeree, for the treatment of the above-mentioned complaints.
Aim:
To assess the acute toxicity potential of the C. angustifolia and M. arundinacea along with their assessment for adaptogenic activity, by noting their effect on forced swimming-induced hypothermia and gastric ulceration in rats.
Materials and Methods:
For acute toxicity study, the effect of test drugs C. angustifolia and M. arundinacea rhizome starch were studied after a single administration of up to three dose levels, with 4400 mg/kg as the maximum dose. The animals were observed for 72 hours periodically and mortality was recorded up to seven days. The adaptogenic and anti-ulcer activities were assessed by determining and comparing the changes in rectal temperature, ponderal changes, ulcer index and histopathological parameters in the test drug group with that of stress control group.
Results:
Both the drugs did not produce any toxic symptoms or mortality even up to the maximum dose level of 4400 mg/kg. Both the test drugs significantly reversed the stress-induced gastric ulceration in comparison to stress-control rats. Starch from rhizome of C. angustifolia reversed forced swimming-induced hypothermia apparently, but not to a significant extent. However, the reversal of hypothermia found statistically significant in the rhizome starch of the M. arundinacea treated group.
Conclusion:
M. arundinacea had better anti-stress activity in comparision to C. angustifolia.
doi:10.4103/0974-8520.159013
PMCID: PMC4492030  PMID: 26195908
Curcuma Angustifolia Roxb.; Gastric Ulcer; Maranta Arundinacea Linn.; Starch; Swimming; Tugaksheeree
9.  Dolichos biflorus Linn. ameliorates diabetic complications in streptozotocin induced diabetic rats 
Ayu  2014;35(4):442-446.
Background:
Horsegram (Dolichos biflorus Linn.) is a known antilithiatic, hypolipedemic and has free radical scavenging activity and increased production of reactive oxygen species play a role in pathophysiological mechanisms that trigger diabetic complications.
Aim:
To see the effect of daily oral feeding of D.biflorous on nephropathy and retinopathy in streptozotocin (STZ) induced-diabetic rats.
Materials and Methods:
A total of 24 healthy rats were randomly grouped into controls, diabetic and diabetic on Dolichos. Diabetes was induced by a single dose of STZ (55 mg/kg) and animals were given prepared food and water ad libitum. Dolichos was orally given at 300 mg/kg/day to rats in diabetic on Dolichos group for next 30 days. Fasting blood glucose levels was monitored at beginning and at the end of the experiment while assessment of serum creatinine levels and histopathological study of kidney and retina was carried only at the end of the experiment. Statistical differences between groups were analyzed using analysis of variance followed by, Bonferroni test as posthoc test.
Results:
Results indicated improvement in serum creatinine levels and reduced glomerular sclerosing and Bowman's space with interstitial alterations and significantly reduced renal hypertrophy in diabetic rat son Dolichos diabetic rats (P < 0.001). Retinal layers showed inconsistent improvement in the width of the neuronal layers and decreased vacuolization of plexiform layers and retinal vessel density.
Conclusion:
D. biflorus at doses of 300 mg/kg/day for 30 days resulted in gradual but significant decreased diabetic nephropathy.
doi:10.4103/0974-8520.159022
PMCID: PMC4492032  PMID: 26195910
Diabetic nephropathy; diabetic retinopathy; Dolichos biflorus; experimental diabetes
10.  Use of Curcuma longa L. extract to stain various tissue samples for histological studies 
Ayu  2014;35(4):447-451.
Background:
Curcuma longa L. is a perennial herb and a member of the Zingiberaceae (ginger) family, which is used extensively in foods as well as in Ayurvedic and Chinese systems of medicine. Current researches have focused on its antioxidant, hepatoprotective, anti-inflammatory, anticarcinogenic and antimicrobial properties. Until now, very few studies suggested its role as a histological stain.
Aim:
To ascertain its efficacy to be used as a counterstain after hematoxylin, to compare it's staining ability with that of routinely used eosin dye and also to ascertain its role in various collagen diseases.
Materials and Methods:
Turmeric rhizomes were cut into small pieces and were dried. These dried turmeric rhizomes were milled to form fine powder, which was then processed to form dye for staining tissue structures.
Results:
It revealed that turmeric can be used as a counterstain after hematoxylin, its staining ability was also good and comparable to that of eosin dye with a special affinity for collagen and muscle fibers.
Conclusion:
Turmeric dye can be used as a histological stain, which stains similar to eosin dye and its specific affinity for collagen and muscle fibers authenticates its role in the treatment of collagen and muscle disorders.
doi:10.4103/0974-8520.159027
PMCID: PMC4492033  PMID: 26195911
Counterstain; Curcuma longa; eosin; hematoxylin; turmeric; Zingiberaceae
11.  Evaluation of polyherbal formulation (SJT-HT-03) for antihypertensive activity in albino rats 
Ayu  2014;35(4):452-457.
Background:
Hypertension is an incurable pathological condition and lifelong therapy is required. Long term use of conventional synthetic anti-hypertensive drugs is associated with a spectrum of toxic effects. However, therapeutic interventions using herbal drugs for hypertension have gained considerable attention worldwide.
Aim:
To evaluate the anti-hypertensive activity of polyherbal formulation (SJT-HT-03).
Materials and Methods:
The polyherbal formulation (SJT-HT-03) comprises of leaves of Aegle marmelos L., fruits of Benincasa hispida Thunb., Garcinia indica Thouars, and flowers of Musa paradiasica L., Rosa indica L., Hibiscus rosa sinensis L. Selected plants as mentioned above were collected, dried and extracted with different solvents. Formulation SJT-HT-03 (250 mg/kg, p.o.), was evaluated using two kidney one clip (2K1C) model and deoxycorticosterone acetate (DOCA)-salt-induced hypertension model using the enalapril (10 mg/kg, p.o.) and hydrochlorothiazide (5 mg/kg, p.o.) as a reference standard drug in respective models.
Results:
SJT-HT-03 significantly reduced (P < 0.001, one-way analysis of variance followed by Turkey's multiple comparison tests) systolic as well as diastolic blood pressure (BP) in 2K1C and DOCA-salt model. Further, SJT-HT-03 has shown a significant reduction (P < 0.01) in angiotensin converting enzyme (ACE) activity in serum, clipped kidney as well as in lungs in 2K1C model, whereas significant reduction (P < 0.05) in serum Na+ and increase in serum K+ level in DOCA model.
Conclusion:
Polyherbal formulation SJT-HT-03 possess significant anti-hypertensive activity by producing direct depressant effect on heart, inhibition of ACE, aldosterone antagonistic as well as diuretic effect and thereby act on multiple targets to achieve optimal effect.
doi:10.4103/0974-8520.159034
PMCID: PMC4492034  PMID: 26195912
Aegle marmelos; anti-hypertensive; polyherbal; two kidney one clip model
12.  Evaluation of analgesic activity of Terminalia arjuna (Roxb.) Wight and Arn bark: A tribal claim 
Ayu  2014;35(4):458-461.
Background:
Plants occupy an important place in folk medicine all over the world for centuries and indigenous communities have developed their own specific knowledge on plant resources, uses, management, and conservation. Research interest and activities in the area of ethno medicine have increased tremendously in the last decade. Currently, scientists are evincing keen interest in the scientific evaluation of ethno medical claims. Bark powder of Arjuna (Terminalia arjuna [Roxb.] Wight and Arn) is used by tribals for the management of some painful conditions.
Aim:
To evaluate analgesic activity of T. arjuna bark in rodents.
Materials and Methods:
For evaluation of analgesic activity, different experimental models, that is, the acetic acid-induced writhing syndrome in mice, formaldehyde-induced paw licking response and tail flick test in rats were designed. Experiments were carried out at two-dose levels, that is, therapeutically equivalent dose (TED) and TED × 2. Animals were divided into three groups (six animals in each group), first group serving as a control group, second and third group labeled as test drug group.
Results:
Test drug at both the doses significantly decreased the writhing syndrome in comparison to control the group. In comparison to control the group, incidences of formalin-induced paw licking were reduced in test drug groups in both early and late phases of pain. In tail flick response, threshold was significantly increased in both test drug groups at every time intervals.
Conclusion:
Study showed that stem bark of T. arjuna possesses analgesic activity in all experimental models.
doi:10.4103/0974-8520.159041
PMCID: PMC4492035  PMID: 26195913
Arjuna bark; pain; reverse pharmacology
13.  Management of spastic cerebral palsy through multiple Ayurveda treatment modalities 
Ayu  2014;35(4):462-466.
Background:
Cerebral palsy (CP) is a leading cause of childhood disability affecting function and development. The global incidence of CP is 2:1000. It has been reported that children with CP and their caretaker have impaired health-related quality of life (QOL). Of the many types and subtypes of CP, none has any known cure. For a detailed description of the disease CP, though, there is no one to one correlation in Ayurvedic classics; it can be taken as Vata Vyadhi as far as its etiology and symptomatology are concerned.
Aim:
To assess the effect of certain Panchakarma procedures in the management of CP.
Materials and Methods:
Total 8 patients were registered and treated with 5 days of Udvartana, 5 days of Abhyanga followed by Sarvanga Swedana and then 8 days of Yoga Basti. The same course of treatment has been repeated for 3 times with an interval of 14 days. Ashtanga Ghrita was given during whole procedures as internal medication. Results of treatment were assessed with anthropometrical measurement, developmental milestone, Modified Ashworth Scale, spasm scale, reflex scale, and muscle power grading.
Result:
This Ayurvedic management shows good result in CP patients, especially by improving growth (height, weight, chest circumference) and development (head holding and sitting), reducing spasticity of left upper limb and muscle spasm.
Conclusion:
Multisystem approach is needed to improve the condition of the patient. Panchakarma along with internal medication should be given to improve all the facets of spastic CP. Yoga Basti acts by their own mode of action and can be used freely for such disease conditions.
doi:10.4103/0974-8520.159044
PMCID: PMC4492036  PMID: 26195914
Cerebral palsy; Panchakarma in pediatrics; Yoga Basti
14.  A preliminary physicochemical evaluation of Darvyadi Yoni Varti: A compound Ayurvedic formulation 
Ayu  2014;35(4):467-470.
Background:
Darvyadi Yoni Varti is an Ayurvedic formulation indicated for the management of Garbhasaya Grivamukhagata Vrana (cervical erosion). Though a number of drugs are available in modern medicine, interest towards Ayurveda is gaining. Drugs with Vranasodhana, Ropana and Prasadana properties like Sphatika, Darvi, Haridra, and Lodhra are useful in this situation and are selected to prepare Yoni Varti.
Aim:
To standardize and evaluate preliminary pharmacognostical as well as physicochemical profiles of Darvyadi Yoni Varti.
Materials and Methods:
Raw material was analyzed in the Pharmacognostical Laboratory for genuinity before converting into Varti. Finished product was analyzed by following pharmacopoeial standards.
Results:
The pH value of Darvyadi Yoni Varti was 5.0, water soluble extract was 23.3%w/w, alcohol soluble extract was 8.7%w/w, ash value was 5.16%w/w, loss on drying was 71.73%w/w. High performance thin layer chromatography was carried out; in which maximum 10 spots at 254 nm and 3 spots at 366 nm were distinguished.
Conclusion:
Pharmacognostical study of raw drug revealed the quality and genuineness of all the constituents of Darvyadi Yoni Varti.
doi:10.4103/0974-8520.159048
PMCID: PMC4492037  PMID: 26195915
Cervical erosion; Darvyadi Yoni Varti; Garbhasaya Vrana
15.  Preliminary pharmacognostic and phytochemical standardization of Dhataki [Woodfordia fruticosa (L.) Kurz.] leaves 
Ayu  2014;35(3):309-315.
Background:
Woodfordia fruticosa (L.) Kurz., known as Dhataki, is an important medicinal plant used in Ayurveda. Recent studies on leaf showed that it contains important chemical constituents responsible for biological activities. The ethnic folk from India and Nepal are using the leaf to treat ulcers, rheumatism, fever, hemoptysis and as a disinfectant. It is also reported to be used in perfume, leather and textile industries.
Aim:
To investigate preliminary pharmacognostical and phytochemical parameters of leaf to standardize the drug.
Materials and Methods:
Identification of plant was done as per the standard guidelines given in the floras. Macro and microscopic evaluation performed as per the routine laboratory procedures. Phytochemical, physico-chemical, florescence analysis, behavior of powdered drug have been conducted as per the WHO guidelines.
Results:
Unique arrangement of the vascular bundle in mid rib region is observed. Aqueous and alcoholic extracts showed the presence of alkaloids, phenols, tannins, and flavonoids.
Conclusion:
The findings of this study will be helpful in the identification of Dhataki leaf.
doi:10.4103/0974-8520.153752
PMCID: PMC4427835  PMID: 25972722
Dhataki; pharmacognosy; physico-chemical; Woodfordia fruticosa
16.  Antibacterial activity of Withania somnifera against Gram-positive isolates from pus samples 
Ayu  2014;35(3):330-332.
Background:
Withania somnifera is an important medicinal plant that has been used in Ayurvedic and indigenous medicine since ancient times. In the view of its varied therapeutic potential, it has also been the subject of considerable modern scientific attention. Attention has been drawn to antibacterial activity of the plant and its metabolites due to the challenge on growing antibacterial resistant pathogens.
Aim:
To examine the antimicrobial potential of leaf extract of W. somnifera against Gram-positive cocci.
Materials and Methods:
In this study, leaf extract of W. somnifera was used to examine their antimicrobial potential against Gram-positive cocci (n = 20) from pus samples of patients admitted in Government Medical College, Haldwani. Agar well diffusion method was used by taking methanolic leaf extract of W. somnifera.
Results:
It was observed that the methanolic leaf extract of W. somnifera was very effective in inhibiting the test pathogens including methicillin resistant Staphylococcus aureus and Enterococcus spp., with an average zone of inhibition of 20.6 mm and 19.4 mm at 2 mg/ml (100 μl) concentration, respectively.
Conclusion:
These results indicate that the antimicrobial property of W. somnifera leaf supports the traditional use of the plant in therapeutic use against microbial infections.
doi:10.4103/0974-8520.153757
PMCID: PMC4427836  PMID: 25972723
Enterococcus; methicillin resistant Staphylococcus aureus; Withania somnifera
17.  Effect of Triphala on dextran sulphate sodium-induced colitis in rats 
Ayu  2014;35(3):333-338.
Background:
Herbal products from Ayurveda were always in the forefront in providing leads to new drug discovery. Triphala, an ancient Ayurvedic herbal formulation comprises of equal portions of Amalaki, Bibhitaki and Haritaki and is used extensively for constipation, as an anti-inflammatory, analgesic, anti-arthritic, hypoglycemic and an anti-aging agent.
Aim:
To evaluate the effect of Triphala on dextran sulphate sodium induced colitis in rats.
Materials and Methods:
Present study carried out in total five groups (n = 6 in each group); first group served as normal, second group control, third group standard control and remaining two as test drug groups. Mesalzine was used as a standard drug for comparison. Two doses (150 mg/kg and 300 mg/kg) of Triphala were given as treatment for two separate groups of colitis rats for 7 days. C-reactive protein, superoxide dismutase, catalase, malondialdehyde levels were evaluated and histological study of the distal colon was conducted.
Results:
The colitis rats treated with higher dose of Triphala (300 mg/kg) exhibited normal parameters similar to normal control group animals, which is on par with standard drug mesalzine effect.
Conclusion:
The results suggest that Triphala (300 mg/kg) has a considerable and reliable effect in reducing colitis in rats. This effect can be attributed to its antioxidant activity and well presence of flavonoids.
doi:10.4103/0974-8520.153787
PMCID: PMC4427837  PMID: 25972724
Antioxidant; colitis; dextran sulphate sodium; inflamatory mediators; Triphala
18.  Consequences of excessive use of Amlarasa (sour taste): A case-control study 
Ayu  2014;35(2):124-128.
Background:
Palatability is an important factor for choice of food by an individual. Amlarasa (sour taste) is one of the main organoleptic entities in foods of present day, which always tempts the consumer to take it now and then. According to classical Ayurvedic texts, balanced intake of Amlarasa in diet helps to maintain physiological health, but its excessive intake produces some signs and symptoms such as dentine hypersensitivity, stomatitis, halitosis, heartburn, urticaria, papule and joint inflammation.
Aim:
To establish the relationship between excessive use of sour predominant diets and signs/symptoms produced by it.
Materials and Methods:
A case-control survey study was designed wherein total of 178 volunteers were interviewed personally. Subjects with particular symptoms consider as a cases while healthy volunteers as controls. To measure the excessive intake of Amlarasa, quantity and frequency of common food articles such as mango, tomato, lime, butter milk, tamarind, curd, fermented items etc., are taken into consideration. Data was arranged in to 2 × 2 table and odd ratio was calculated for each symptom.
Results:
Odds ratio for dentine hypersensitivity, stomatitis, halitosis, heartburn, urticaria, papule and joint inflammation with 95% confidence interval were found 1.95 (0.97-3.93), 2.45 (1.12-5.40), 2.76 (0.96-7.98), 2.21 (1.09-4.53), 0.86 (0.32-2.32), 2.28 (1.02-5.05) and 4.85 (1.09-10.24) respectively.
Conclusion:
Study reveals that Amlarasa is a risk factor for joint inflammation, dentine hypersensitivity, stomatitis, halitosis, heartburn and papules. Study supports the Ayurvedic classical claim regarding Atiyoga of Amlarasa.
doi:10.4103/0974-8520.146204
PMCID: PMC4279316  PMID: 25558155
Amlarasa; Atiyoga; excessive intake; sour taste; survey
19.  An observational pilot study on the effect of Gomutra Haritaki, diet control and exercise in the management of Sthaulya (obesity) 
Ayu  2014;35(2):129-134.
Background:
India is currently witnessing rising numbers of people in the middle-class who are obese. A lot of the Indian population has started relying on processed foods that contain a huge percentage of trans-fat, sugars, and other unhealthy and artificial ingredients. Obesity is considered the core of many diseases. Increased weight carries significant health risks for some cancers, diabetes, heart diseases and strokes. Junk food, alcohol and sedentary lifestyle are leading us to silent self destruction, making one in every five Indian men and women either obese or overweight.
Aim:
To determine the effect of Gomutra Haritaki on Sthaulya.
Materials and Methods:
An observational pilot study on the effect of Gomutra Haritaki, diet control and exercise in the management of Sthaulya (obesity) was conducted on 21 patients. Enrolled patients were screened on the basis of clinical findings and allocated into two groups. Trial group received Gomutra Haritaki (6 g/day in three divided doses) while control group received placebo capsules in the same dose for 8 weeks.
Result:
Statistically highly significant relief was found in weight reduction (P < 0.001), and body mass index (BMI) (P < 0.01) in both groups. Control group has shown better results against trial group.
Conclusion:
These results prove the impact of diet and exercise in the management of Sthaulya.
doi:10.4103/0974-8520.146206
PMCID: PMC4279317  PMID: 25558156
Cow's urine; Gomutra; Haritaki; obesity; Sthaulya; Terminalia chebula
20.  A clinical study on the efficacy of Panchavalkala cream in Vrana Shodhana w.s.r to its action on microbial load and wound infection 
Ayu  2014;35(2):135-140.
Background:
The science of wound healing is advancing rapidly, particularly as a result of new therapeutic approaches. The wound healing effect of different herbal ointments have been enormous and are in wide practice these days.
Aim:
To evaluate the efficacy of Panchavalkala cream over wound debridement (wound infection and microbial load).
Materials and Methods:
Ghanasatwa (water extract) of the individual drugs of Panchavalkala was prepared and the extract formulated as herbal ointment. This was used to treat patients of infected chronic non healing wounds. The signs and symptoms of infection were graded before and during the course of treatment. Tissue biopsy to estimate the microbial load prior to and during the course of treatment was done.
Results:
The clinical symptoms like Slough, swelling, redness, pain, discharge, tenderness, and malodor in wounds showed statistically significant reduction following treatment. The microbial load of the wounds was also reduced significantly.
Conclusion:
In most of the cases, there was a progressive reduction in the microbial load with time, during the course of treatment indicating the efficacy of the formulation in reducing the microbial load and thus controlling infection, facilitating wound healing.
doi:10.4103/0974-8520.146216
PMCID: PMC4279318  PMID: 25558157
Chronic non healing wounds; infection; microbial load; Panchavalkala; Vrana Shodhana
21.  Comparative study of Ksharasutra suturing and Lord's anal dilatation in the management of Parikartika (chronic fissure-in-ano) 
Ayu  2014;35(2):141-147.
Background:
Parikartika resembles fissure-in-ano which is very common among all ano-rectal disorders. In Ayurvedic texts, Parikartika is described as a complication of Vamana and Virechana as well as complication of Atisara. Ksharasutra was proved successful in the management of fistula-in-ano, piles, and there is a need to try its efficacy in fissure-in-ano.
Aim:
To evaluate the role of Ksharasutra suturing (KSS) in fissure bed in chronic fissure-in-ano.
Materials and Methods:
Total 100 patients of chronic fissure-in-ano were selected and randomly divided into two groups (50 in each group). In group-A, patients were undergone by KSS; while in patients of Group-B Lord's anal dilatation followed by KSS was done under spinal anesthesia. The KSS was done once and after slough out of Ksharasutra, the wound was treated for 4 weeks and assessment of the result was done on the basis of gradation adopted.
Results:
The pain relief on 14th day in Group-A was 86% while in Group-B 100% was observed. As on 7th day in Group-A, oozing was stopped in 68% patients, while in Group-B, oozing was stopped in 82% patients. On 21st day, Group-B showed more healing (85%) as compared to Group-A (69%). In this study 68% of patients were cured.
Conclusion:
In Group-B (KSS with Lord's anal dilatation) patients were cured early as compared to patients of Group-A (KSS alone).
doi:10.4103/0974-8520.146219
PMCID: PMC4279319  PMID: 25558158
Fissure-in-ano; Ksharasutra; Lord's anal dilatation; Parikartika
22.  Effect of Anuvasana Basti with Ksheerabala Taila in Sandhigata Vata (Osteoarthritis) 
Ayu  2014;35(2):148-151.
Background:
Osteoarthritis (OA) is the most common joint disorder. In Ayurveda the disease Sandhigata Vata resembles with OA, which is described under Vatavyadhi. Treatment provides symptomatic relief, but the underlying pathology remains unchecked due to the absence of effective drugs. In the management of Sandhigata Vata, all the Acharyas have described the employment of Bahya Snehan, Swedana, Abhyantara Tikta Snehapana, Basti treatment and Guggulu Prayoga.
Aim:
To evaluate the effect of Ksheerbala Taila Anuvasana Basti in Sandhigata Vata
Materials and Methods:
In the present study, 30 patients of Sandhigata Vata were given Anuvasana Basti with Ksheerabala Taila. Subjective assessment of pain by visual analog scale and swelling, tenderness, crepitus and walking velocity were graded according to their severity.
Results:
Significant results (P < 0.05) were found in all the cardinal symptoms – Pain (Sandhiruja), Swelling (Shotha), tenderness, crepitus and walking velocity. Radiological findings showed no significant changes.
Conclusion:
Anuvasana Basti with Ksheerabala Taila was significant in the subjective symptoms of Sandhigata Vata.
doi:10.4103/0974-8520.146225
PMCID: PMC4279320  PMID: 25558159
Anuvasana Basti; Ksheerabala Taila; Sandhivata
23.  A comparative clinical study of Asanadi Ghanavati and Gomutra Haritaki in Kapha Medo Margavarana (dyslipidemia) 
Ayu  2014;35(2):152-159.
Background:
Dyslipidemia is a disorder of lipoprotein metabolism, including lipoprotein overproduction or deficiency and it can be understood in the parlance of the closest conditions in Ayurveda, viz. Kapha Medo Margavarana (dyslipidemia), Atisthaulya (obesity) or Meda Roga and Prameha. Asanadi Ghanavati (AG) is a modified presentation of Asanadi Gana drugs referred in Ashtanga Hridaya and Gomutra Haritaki (GH) is described in Charaka Samhita under Shotha Chikitsa and Ashtanga Hridaya in Arsha Chikitsa.
Aim:
To evaluate and compare the clinical effect of AG and GH in Kapha Medo Margavarana.
Materials and Methods:
Patients with the high lipid profile were selected and randomly divided into two groups. In Group A (n = 30), patients were administered with tablet of AG 1 g (500 mg each) thrice a day for 8 weeks and in Group B (n = 30), tablet of GH in similar dose and duration. Effect of therapy was assessed by body circumference, Body Mass Index (BMI), cardinal symptoms like Anga-Gaurava, Bharavriddhi, etc., and lipid profile parameters.
Result:
AG decreased the serum cholesterol by 7.12%, Serum Triglyceride (S. TG) by 7.72%, Serum Low Density Lipoprotein (S. LDL) by 11.68%, Serum Very Low Density Lipoprotein (S. VLDL) by 7.73%, and had increased Serum High Density Lipoprotein (S. HDL) by 9.52%, with moderate improvement in 14.81% and mild improvement in 70.37% of patients. The GH decreased the serum cholesterol by 6.31%, S. TG by 9.61%, S. LDL by 12.55%, serum VLDL by 8.99%, and increased S. HDL by 10.52% with moderate improvement in 3.70%, and mild improvement in 74.07% patients.
Conclusion:
AG and GH are suggested to be used in Kleda Bahul Samprapti Janya Vyadhi and Ama Bahul Samprapti Janya Vyadhi respectively.
doi:10.4103/0974-8520.146231
PMCID: PMC4279321  PMID: 25558160
Asanadi Ghanavati; dyslipidemia; Gomutra Haritaki; Kapha Medo Margavarana
24.  Low resource screening method of pre-cancerous lesions and its reversal by Triphala in teen-age Indian population 
Ayu  2014;35(2):160-167.
Background:
Cancer screening is the main weapon for early detection at a pre-invasive or premalignant stage. It has been reported that over 12 million people use some form of tobacco, which is one of the high risk factors and has hence become an alarming world-wide problem.
Aim:
To evaluate the effective diagnostic screening of disease in its early stage by inexpensive method and also to evaluate the effect of indigenous mouthrinse on reversal of pre-cancerous lesions.
Materials and Methods:
The screening for teenagers belonging to low socio-economic status was carried out. Suspected subjects were evaluated for the reversal of the lesions by use of Ayurvedic preparation as a mouthwash. From 13 to19 years working-child population of North India was selected for the study. Screening was performed by new method-visual inspection with acetic acid. The positive subjects were further investigated by pap smear and biopsy was done as a confirmatory histopathological report. In second phase, the subjects showing positive lesions were advised indigenous anti-cancer mouth rinse and its effect was evaluated after 6 month and 9 month of prescribing the rinse.
Results:
The total 1095 children were screened (831 boys and 264 girls). Out of total 34 teenager boys were diagnosed, as acetowhite positive lesion. All the acetowhite positive lesions were found exclusively in males. Histological findings after 9 month use of Triphala mouth rinse revealed no changes in cells in 23 (85.2%), hyperkeratinization in 2 (7.4%), hyperkeratinization and spongiosis was evident in 1 (3.7%), mild pleomorphism in 1 (3.7%) patient. Comparative evaluation from 0-9 month showed statistically highly significant test (P < 0.01).
Conclusion:
Use of different forms of tobacco and betel nut showed convincing relationship between developments of oral pre-cancerous lesions. Triphala was found to have great potential for reversal of these lesions.
doi:10.4103/0974-8520.146233
PMCID: PMC4279322  PMID: 25558161
Alcohol; oral pre-cancerous lesions; screening; tobacco; Triphala and teenagers
25.  Efficacy of Varunadi Ghritha (polyherbal compound) in treated head and neck cancer cases as a biological response modifier 
Ayu  2014;35(2):168-174.
Background:
Persistent immune suppression is reported in Head and Neck Cancers (HNC) even after treatment and a higher recurrence rate was observed in patients with poor CD3 count. Loco regional recurrences and second primary tumours are the common forms of failure in head and neck cancers. Several agents have been tried to overcome this problem without much benefit. In Ayurveda, several plant based products have been reported to have anti-tumour and immunomodulatory properties.
Aim:
To test the role of Varunadi Ghritha, as an immunomodulator in apparently healthy, treated and controlled HNC patients and to evaluate its effectiveness in preventing locoregional relapses and development of second primary tumours.
Materials and Methods:
Total 78 patients of treated head and neck cancers were randomly selected for intervention and control group. Patients in the intervention group (n = 38) received Varunadi Ghritha, 5gms twice daily for one year and followed up to two years. Patients in the control group (n = 40) were followed up at regular intervals. Immune parameters were assessed in the peripheral blood at base line and at the end of administration of the study compound.
Results:
In the intervention group, mean percentage increase in CD3, CD19 and CD16 positive cells were significantly higher after the administration of the study compound compared to the control group indicating an immunomodulatory effect of the study compound. A non-significant improvement in disease control was observed in patients with advanced stage of disease in the intervention group.
Conclusion:
Administration of Varunadi Ghritha resulted in an increase in T cell counts in patients with treated HNC.
doi:10.4103/0974-8520.146236
PMCID: PMC4279323  PMID: 25558162
Ayurveda; head and neck cancer; immunomodulation; loco-regional control; second primary tumour

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