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Ayu. 2012 Jan-Mar; 33(1): 102–109.
PMCID: PMC3456846
Effect of Kuberaksha Patra Churna, Vriddhadaru Mula Churna and Kandughna Taila in Shlipada (Manifested filariasis)
Goli Penchala Prasad and M. L. Naidu1
Research Officer (Ay), Scientist-3, National Institute of Indian Medical Heritage, Osmania Medical College, 3rd Floor, Putli Bowli, Koti, Hyderabad, India
1Professor and Ex Head, Department of Kaya Chikitsa, Dr. N.R.S. Government Ayurvedic College, Vijayawada, Andhra Pradesh, India
Address for correspondence: Dr. Goli Penchala Prasad, Research Officer(Ay), Scientist-3, National Institute of Indian Medical Heritage, Osmania Medical College, 3rd Floor, Putli Bowli, Koti, Hyderabad - 500 095, India. E-mail: drprasadgoli/at/yahoo.com
At present there are effective drugs in eradicating microfilariae but treatments to control the progression of manifested filariasis, periodic adenolymphangitis (ADL) and lymphedema are not available in conventional system of medicine. So far National Ayurveda Research Institute for Vector-borne diseases, Vijayawada, has conducted many clinical trails on manifested filariasis patients with the classical Ayurvedic herbal, herbo-mineral drugs and found significant results on ADL, lymphedema and other acute and chronic clinical manifestations. An effort has been made to find the effect of Kuberaksha Patra Churna [Caesalpinia bonduc (L.) Roxb.], Vriddhadaru Mula Churna [Argyreia nervosa (Burm.f.) Boj.] and Kandughna Taila (oil prepared from 10 Ayurvedic drugs) in manifested filarial patients. Based on inclusion criteria 133 patients were included in three groups (45 in Gr.I, 45 in Gr.II and 43 in Gr.III) and 120 patients completed the study (40 in each group). In Gr. I Argyreia nervosa (Burm.f.) Boj. root powder, Caesalpinia bonduc (L.) Roxb. leaf powder mixed equally was given in the dose of 5 g twice a day for 30 days. In Gr.II along with Gr. I internal drugs Kandughna Taila was applied externally in sufficient quantity once a day for 30 days. Gr. III is a control study with Ayurvedic established drug ‘Nityananda Rasa’ 1 tablet thrice daily for 30 days. Group I and II drugs showed highly significant effect on lymphedema, lymphadenitis, lymphangitis, pain, tenderness, heaviness, deformity, fever and rigors (P<0.0001). Group III drug showed highly significant (P<0.0001) effect on lymphedema, deformity and heaviness; statistically significant (P=0.0018) on pain and tenderness; Significant effect on fever (P=0.0290), rigor (P=0.0290) and in lymphangitis (P=0.0384) and non-significant effect on lymphadenitis (P=0.1033). On statistical analysis effect of treatment on Hb and eosinophil count was found non-significant in three groups. On ESR, effect of treatment was found significant in Gr. III and non-significant in Gr. I and Gr. II.
Keywords: Argyreia nervosa, Caesalpinia bonduc, fever, filariasis, lymphadenitis, lymphangitis, lymphedema, Shlipada
As per World Health Organization 120 million people living in 81 tropical and subtropical countries of the world are infected with lymphatic filariasis and an estimated 1.34 billion live in areas where filariasis is endemic.[1] In comparison to global population, India is the largest Filariasis endemic country, contributing about 40% of total global burden of Filariasis.[2] In Ayurveda, Shlipada is correlated with Filariasis of contemporary science. As per Ayurvedic literature Shlipada is caused by vitiation of Tridoshas (three body humors) and among these three body humors, Kapha type of body humor plays an important role both in disease progression and treatment. Charaka explained this as sub type of Shotha (edema).[3] Sushruta, has given detailed description of Shlipada covering the etiopathogenesis, clinical features, types and prognosis.[4,5] Ancient Ayurvedic texts like Bhaishajya Ratnavali, Vrindamadhava, Yogaratnakara, Bhavaprakasha etc., indicated many herbal and herbo-mineral drugs and formulations for the treatment of filariasis. Many of these formulations have been studied on filariasis. To establish the effect on manifested filarial patients, two internal single drugs and one external formulation were selected based on Ayurvedic classics, pharmacological studies, preclinical studies and clinical studies.
In Ayurvedic texts of Bhaishajya Ratnavali, Yogaratnakara and in Vrindamadhava leaf juice of Kuberaksha and root powder of Vriddhadaru are indicated in Filariasis.[68] As per Ayurveda bitter and astringent taste, light, dry properties, hot potency and pungent nature in post-digest effect, anti-edema, analgesic actions of Caesalpinia bonduc leaf powder and pungent, bitter and astringent taste, light, hot potency, Kapha (body humor) pacifying nature, wound healing, anti-edema actions of Argyreia nervosa supports the selection of these drugs in Shlipada.[9] Pharmacologically anti-inflammatory, antimicrobial, effect of Caesalpinia bonduc, antimicrobial and antibacterial effect of Argyreia nervosa were proved.[10] In earlier researches in acute cases of Filariasis and in Microfilaremia the effect of AYUSH 64 was proved. In AYUSH 64 among the four ingredients Caesalpinia bonduc seed is the important ingredient.[1113] Effect of the aqueous and alcoholic extracts of the leaves of Argyreia nervosa on the spontaneous movements of both the adult worm and a nerve/muscle preparation of Setaria cervi, a filarial worm of cattle, and on the survival of microfilariae in vitro was studied. The aqueous extract in a dose of 150 μg/ml. caused a decrease in tone and amplitude of spontaneous movements of the worm. A similar response was produced by the alcoholic extract but at a much lower concentration of 75 μg/ml. The aqueous extract produced complete paralysis of the nerve/muscle preparation in a dose 25 μg/ml whereas with alcoholic extract only 50 ng/ml was required.[14] Although in both the above cases the useful parts are different, it can be presumed that the same active principles also present in leaves of Latakaranja (Caesalpinia bonduc) and root of Vriddhadaru (Argyreia nervosa) and selected for Gr.I study.
In Gr-II along with Latakaranja and Vriddhadaru, Kandughna Taila was used externally. Studies in chronic lymphedema patients proved that bacterial invasion in skin initially cause dermatitis and later leads to Adenolymphangitis (ADL) and progression of disease. To prevent the disease progression, in Gr.II externally medicated oil is also indicated. Among the 10 ingredients of Kandughna Taila (oil prepared from Charaka Kandughna Dashemani and sesame oil) on external use, all are having anti-itching and skin protecting property. Among them Chandana (Santalum album Linn.) and Nalada (Vetiveria zizanioides (Linn) Nash) pacifies burning sensation; Kritamala (Cassia fistula L.), Madhuka (Glycyrrhiza glabra L.), Musta (Cyperus rotundus L.), Daruharidra (Berberis aristata DC.) have anti-edema property; Cassia fistula, Vetiveria zizanioides, sesame oil, have analgesic action. Sesame oil and Berberis aristata possess wound cleaning property. Sesame oil and Naktamala (Pongamia pinnata Pierre.) have wound healing property, Santalum album and Vetiveria zizanioides possess complexion promoting property and Pongamia pinnata has wormicidal properties.[15] Antibacterial, antiviral, antiprotozoal, antimicrobial, antifungal, anti-inflammatory, analgesic, antiulcer, antiexudative, wound healing and smooth muscle relaxant properties of the ingredients also supports the selection of this oil in the treatment of Filariasis.[10,1618]
Group III is Control group with Ayurvedic established drug Nityananda Rasa. Nityananda Rasa is a well-established drug in Ayurvedic system of medicine and used in both acute and chronic cases as a drug of choice. As per Rasendra Sara Sangraha and Bhaisajya Ratnavali it is very useful in alleviating Shlipada (Filariasis).[6,19]
With this background an attempt was made to establish the effect of Caesalpinia bonduc leaf powder, Argyreia nervosa root powder and Kandhughna Taila in Filariasis.
Aims and objective
  • To assess the effect of Kuberaksha Patra Churna and Vriddhadaru Mula Churna in various clinical and laboratory findings of Shlipada.
  • To assess the synergetic effect of Kuberaksha Patra Churna and Vriddhadaru Mula Churna along with external application of Kandhughna Taila.
  • To compare the effects Kuberaksha Patra Churna, Vriddhadaru Mula Churna and Kandhughna Taila with established Ayurvedic drug Nityananda Rasa.
Criteria for inclusion
  • Patients with visible lymphedema, who were already diagnosed and established as Manifested Filarial patients by the chronicity, clinical manifestations, periodic episodes having cardinal signs and symptoms like lymphadinitis, lymphangitis, deformity, pain, tenderness, fever, rigors, etc. were selected for present study.
  • Patients should be with in the age limit of 5-70 years and chronicity of the disease should be more than 1 year.
Criteria for exclusion
Patients having nodular deformity, thorny deformity, anthill like deformity, nutritional edema, edema due to liver and cardiac disorder, arthritic disorder are excluded from the study.
Place of study
Present study was conducted at National Ayurveda Research Institute for Vector-borne diseases (formerly Regional Research Institute), Vijayawada (Institute under Central Council For Research in Ayurvedic sciences, Department of AYUSH, M/o Health and Family Welfare, Govt. of India) during 2009-2011. This study was approved by Institutional Ethics Committee of National Ayurveda Research Institute for Vector-borne diseases, Vijayawada.
Drugs and dose
Drug collection, identification and standardization and estimation of heavy metals of Caesalpinia bonduc (L.) Roxb leaf powder, Argyreia nervosa (Burm.f.) Boj. root powder was done at Plant Taxonomy Division, Laila Impex R & D Centre, Vijayawada.[20,21] Standardization of Kandhughna Taila was also conducted at Plant Taxonomy Division, Laila Impex R and D Centre, Vijayawada [Figures [Figures113].[22]
Figure 1
Figure 1
Kuberaksha Patra Churna [Caesalpinia Bonduc(L.) Roxb. leaf powder]
Figure 3
Figure 3
Kandughna Taila (oil prepared from 10 Ayurvedic drugs-Charaka Dasaimani)
Figure 2
Figure 2
Vriddhadaru mula curna [Argyreia nervosa(Burm.f.) Boj. root powder]
In Group - I Argyreia nervosa (Burm.f.) Boj. root powder, Caesalpinia bonduc (L.) Roxb. leaf powder mixed equally was given to 45 patients in the dose of 5 g twice a day with water before food for 30 days. In Group-II, 45 patients were given Gr.I internal drugs along with external application of Kandughna Taila once day for 30 days. In Gr. III, 43 patients were given control drug (Ayurvedic established drug) Nityananda Rasa 1 tablet (125 mg) thrice a day after food for 30 days. Nityananda Rasa of Baidyanath Ayurveda Pharmacy was purchased from the market at a time with same batch number and date (080160/October 2008). If the age of the registered patients is found to be less than 12 years; the dose was reduced by 50%.
Safety profile
Argyreia nervosa (Burm.f.) Boj, LD 50 of seed extract is 500 mg/ kg body weight. Methanol, benzene, chloroform, petroleum ether extracts of the plant were found non-toxic in dose range of 100-750 mg/kg i.p. as observed during 72 hours after administration.[18]
In a subacute toxicity study in rat, ‘Ayush-64’ an Ayurvedic antimalarial drug (containing seeds of C. bonducella as one of the constituents) when administered orally at the dose of 500 mg/kg for 30 days it did not show any toxic effects hematologically, biochemically and histologically at the cellular level.[23] While standardizing these collected drugs safety profile including heavy metal toxicity was done and found in normal levels.
Kandughna Taila is used externally and due its soothing effect in this study it was proved safe. No patient had complained adversely against its external use.
Assessment of result
Detailed history of the patient covering both demographic and other Ayurvedic parameters were noted in separate Proforma. Routine Laboratory investigations covering TC, DC, ESR, Hb, Urine Routine and Microscopic, stool ova/cyst along with DECPT (Diethylcarbamazine citrate provocation test), urine for chyle were investigated at 1st, 8th, 15th, 23rd and 30th days of treatment.
Based on Ayurvedic and Modern disease reviews and research, Central Council for Research in Ayurvedic Sciences, Department of AYUSH, Govt. of India, had prepared a standard protocol and proforma for Shlipda (filariasis). To assess the effect of treatment gradation of parameters with specific scores were denoted in this proforma. In the present study as per the proforma each patient clinical finding were noted in terms of score before the treatment (on date of enrolment) on 8th, 15th, 23rd and 30thdays.
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Basing on the individual score of each finding before and after treatments, the response of the treatment can be assessed. Over all effect of the treatment in each individual patient can be assessed by the below formula. i.e., over all percentage of relief = (Total score of all findings before treatment –Total score of all findings after the treatment) × 100/Total score of all findings before treatment. Patients with 75% or more relief in clinical symptomatology are considered as Good response, 50 to <75% relief is considered as Fair response, 25 to <50% as Poor response and less than 25% as No response. Based on Individual score before and after treatments statistical analysis was also done using Graphpad free software paired ‘t’ test method.
In three groups female patients are more in comparison with males. Mean age in three groups is around 45 years. Mean disease duration (chronicity) is around 10 years. Mean score difference of before and after treatments is more in Gr. II and less in Gr. I [Table 1].
Table 1
Table 1
Demographic pattern
In Gr. I and Gr.III only patients suffering from Filarial legs were included and in Gr. II along with patients with Filarial legs, two filarial hand patients were also included [Table 2].
Table 2
Table 2
The parts affected
In results Good and fair responses are more in Gr. II followed by Gr. I and Gr. III. No responses are more in Gr. III [Table 3].
Table 3
Table 3
The results of the treatment
In percentage of relief of lymphadenitis, lymphangitis, lymphoedema, pain, tenderness, heaviness, fever and rigor more relief was observed in Gr. II followed by Gr. I and least relief were observed in Gr. III [Table 4].
Table 4
Table 4
The relief on over all parameters
On statistical analysis of results, In Gr.II the effect of treatment on acute symptoms like lymphadenitis, lymphangitis, pain, tenderness, fever, rigors and chronic symptoms like lymphedema, swelling (measured at four points of affected leg or hand), heaviness, deformity, etc., were found extremely significant [Table 5]. Although Gr-I, had also shown extremely significant results on all clinical parameters, the percentage of improvement is more in GR-II. This can be assessed by comparing the percentage of relief, mean and SD values of both groups. In comparison with Group II and Group I, Group III had shown less improvement. Being the control group and used as drug of choice in Ayurvedic fraternity this Nityanandarasa (Gr. III) had also shown highly significant (P<0.0001) effect on chronic symptoms like lymphedema and heaviness. Effect of treatment on pain and tenderness is considered to be very statistically significant (P=0.0018). In fever (P=0.0290), rigor (P=0.0290) and in lymphangitis (P=0.0384) the effect is considered to be statistically significant. In lymphadenitis (P=0.1033) the effect is considered to be not statistically significant [Table 5].
Table 5
Table 5
The relief on all clinical parameters
After completion of the study follow-up studies were also carried out and less periodic attacks were observed in Gr. II patients, followed by Gr. I and Gr.III. No patient had developed severe side effects/adverse reactions. Two patients in Gr. I and one patient in Gr. II had diarrhea for 2 days which was relieved by the intake of buttermilk. Five patients in group I and 6 in Gr. II had the feeling of nausea due to the bitter taste of Caesalpinia bonduc (L.) Roxb. leaf powder. Among those 133 enrolled one patient in Group I was hospitalized due to unknown diseases along with acute periodic attack. He discontinued the treatment before completion of the first week of treatment and excluded from the study (drop out). Along with 120 completed cases (40 in each group) of present study four patients in Gr.I, five patients in Gr.II and three patients in Gr.III left the study with out any medical advice (LAMA). As these patients left the study at various intervals, in the present study completed cases (40 in each group) only were considered for the assessment of result.
Before, during and after treatments in lab investigations all the patients were found free from DECPT and chyle in urine. On statistical analysis effect of treatment on Hb and eosinophil count was found non significant. On ESR effect of treatment was found significant in Gr. III and non-significant in Gr. I and Gr. II [Table 6].
Table 6
Table 6
The changes in laboratory parameters
On overall assessment the present study accentuates the positive effect of three group's drugs on Manifested filarial patients’ clinical findings [Figures [Figures449].
Figure 4
Figure 4
Group I before treatment
Figure 9
Figure 9
Group III after treatment
Figure 5
Figure 5
Group I after treatment
Figure 6
Figure 6
Group II before treatment
Figure 7
Figure 7
Group II after treatment
Figure 8
Figure 8
Group III before treatment
On comparison Group II drugs which includes both Gr. I internal drugs and Kandhughna Taila external application had shown better results in comparison with Gr. I and control drug i.e., Gr. III. External application of Kandhughna Taila probably takes care of skin to restrict the periodic episodes, secondary bacterial infections and restriction of adenolymphangitis (ADL). This may be the main reason in minimizing periodic episodes in Gr. II in follow-up studies. The significant effect on ESR of Group III, Nityanandaras indicates its role in reducing internal infection more potently than Gr. I and Gr. II. Further studies with Argyreia nervosa (Burm.f.) Boj. root powder, Caesalpinia bonduc (L.) Roxb. leaf powder can confirm the positive effect of these two drugs including macrofilaricidal activity.
Acknowledgment
The authors are grateful to Dr. G. S. Lavekar, Ex. Director General, CCRAS; Dr. D. Ramesh Babu, Director General, CCRAS; Dr. Ala Narayana, Director, NIIMH, Hyderabad; Dr. G. K. Swamy, A. D (in-charge) NARIVBD, Vijayawada; Shri G. Ganga Raju, Chairman, Laila Group and Mr. G. Rama Raju, Managing Director, Laila Impex for their help and guidance in the study. The authors are highly thankful to Dr. NTR University of Health sciences, Vijayawada, A.P. for providing an opportunity to complete the study under PhD programme.
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