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The common nutritional deficiency, iron deficiency, causes Iron Deficiency Anemia (IDA) throughout the world especially in the developing countries. In Ayurveda, different herbal, mineral or herbomineral drugs have been emphasized to combat anemia (Panduroga). Trikatrayadi Lauha and Fersolate-CM (a modern medicine taken as standard control) were administered to the patients to evaluate their role in Panduroga. A simple random sampling method was followed for the clinical study. The 56 iron deficiency anemic patients of both sexes and age group between 16 to 70 years divided into two groups – Group-A (n=34) and Group-C (n=22) were treated with Trikatrayadi lauha and Fersolate-CM, respectively. Both drugs provided significant effect on the signs and symptoms of Shrama (fatigue), Shwasa (dyspnea on exertion), Daurbalya (weakness), Pandu Varna (pallor/yellowish-whitish), Hridspandana (palpitation), Hatanala (diminished digestive capacity), Bhrama (giddiness), Aruchi (anorexia), Arohana Ayasa (exhaustion during climbing), Shiroruja (headache) and Shotha (edema). Trikatrayadi Lauha provided significant results on Hb gm%, RBC, PCV, MCV, serum iron, percent transferrin saturation and TIBC where as insignificant changes were found in MCH and MCHC. Fersolate-CM provided significant results on Hb gm%, RBC, PCV, MCV, MCH, serum iron, percent transferrin saturation and TIBC whereas insignificant change was found in MCHC. Trikatrayadi Lauha showed significant results on Panduroga and Iron Deficiency Anaemia (IDA).
Panduroga is defined as Pitta dominant Tridoshaja disease where Vivarnata of Twaka (discolouration of skin) is mainly Pandu (pallor/yellowish-whitish) due to Alpa Rakta (reduced blood) or Vidushya Rakta (vitiated blood). Anemia is defined as qualitative and quantitative reduction of circulating RBC and/or the percentage of hemoglobin concentration in relation to standard age and sex. Iron Deficiency Anemia (IDA) is the condition in which there is anemia and clear evidence of iron deficiency. Anemia is the most common disorder of the blood and IDA is the most common type of anemia overall. Many features are found in anemia as per modern literatures and Ayurvedic literatures. Some subjective parameters, which are common in both Panduroga and IDA and objective parameters which are supporting to diagnose IDA, were taken to evaluate the present study. Trikatrayadi Lauha contains Amalaki (Emblica officinalis Gaertn), Haritaki (Terminalia chebula Retz.), Bibhitaka (Terminalia belerica Roxb.), Shunthi (Zingiber officinale Roxb.), Pippali (Piper longum Linn.), Maricha (Piper nigrum Linn.), Chitraka (Plumbago zeylanica Linn.), Musta (Cyperus rotundus Linn.), Vidanga (Embelia robusta Cl.), Lauha Bhasma (incinerated iron), Mandura [hydrated ferric oxide (Fe2O3, H2O)] Bhasma, Sita (Sugar candy), cow-ghee and honey. Amalaki may increase the bioavailability of iron absorption from Lauha Bhasma, Mandura Bhasma. Musta also contains copper and manganese that may increase iron metabolism and hemoglobin synthesis. Generally purified herbomineral drugs have no adverse effect whereas Fersolate-CM (Dried Ferrous sulfate 195 mg, Copper sulfate 2.6 mg, Manganese sulfate monohydrate 2.0 mg.) has adverse drug reaction. Considering this, an attempt has been made to evaluate a comparative hematinic activity of Trikatrayadi Lauha and Fersolate-CM.
Diagnosis was done on the basis of signs and symptoms of Panduroga and IDA. Investigations of blood, urine and stool have been carried out to diagnosis and to rule out any other pathology. A simple random sampling method was followed for the clinical study. The Vati (pill) of Trikatrayadi Lauha (250 mg each) was prepared. According to original reference Kanta Lauha (iron having magnetic property) Bhasma is to be used but in this study, simple Lauha Bhasma was taken for the preparation due to its nonavailability. All ingredients of the trial drug were collected, approved and prepared at Pharmacy, IPGT and RA, Gujarat Ayurved University. The Pharmacognostical studies of the ingredients of Trikatrayadi Lauha and Analytical studies of Trikatrayadi Lauha were also carried out. Fersolate-CM was bought from market. Ethical clearance was obtained from IEC of IPGT and RA, GAU, Jamnagar.
The 78 patients of both sexes were registered with their written informed consent voluntarily from OPD and IPD of Hospital at IPGT and RA, GAU, Jamnagar, Gujarat. Out of them 56 patients completed the treatment and they were divided into two groups.
Pathya (Beneficial diet): Green leafy and root vegetables, patol (Trichosanthus dioica), spinach, Purana Shali (one type of old rice, Oriza sativa), Yava (barley), beet root, rice flakes, bajra, ragi, bengal gram, Mudga (Phaseolus radiatus), Adhaki (Cajanus cajan), Mashur (Lens culinaris), turmeric, apple, Amalaki (Emblica officinalis), Dadimba (Punica granatum), banana, sitaphal (Annona squamosa), dry fruits, Kharjur (Phoenix dactylifera), Mridvika (Vitis vinifera), nuts and seeds (poppy seed, black pepper, etc.), yeast, liver, Jangala Mamsa (meat of domestic animal), fish, etc.
Apathya (Contraindicated diet and activities): Kshar (alkali), Amla (sour), Lavan (salt), Atiushna (excessive hot), Atitikshna (excessive pungent), Masha (black gram), Pinyaka (pasted sesame seed), Tila Taila (sesame oil), Nishpava (lablab bean), Mrittika (soil), Madya (alcohol), coffee, tea, milk, egg yolk, maize, wheat, Viruddha and Asatmya Ahara (incompatible and unwholesome food), Divaswapna (day sleep), Ratrijagarana (night awakening), Ativyayama (excessive exercise), Atimaithuna (excessive intercourse), Vegadharana (suppression of natural urges), Krodha (anger), Chinta (thought), Shoka (grief), etc.
The improvement of patient was assessed mainly on the basis of following points:
Majority of the patients suffering from Panduroga were found in female (91.03%), age between 31 and 50 years (56.41%), married (91.03%) and vegetarian (67.95%) group.
Trikatrayadi lauha provided highly significant effect in relieving Shrama (47.91%), Shwasa (54.0%), Daurbalya (62.94%), Pandu Varna (14.53%), Hridspandana (51.92%), Hatanala (74.31%), Bhrama (65.64%), Anna Aruchi (95.98%), Arohana Ayasa (47.09%), Shiroruja (88%) and Shotha (55.50%) whereas Fersolate-CM showed highly significant effect in relieving Shrama (59.52%), Shwasa (69.35%), Daurbalya (82.50%), Pandu Varna (30.79%), Hridspandana (75%), Bhrama (74.73%), Anna Aruchi (85%), Arohana Ayasa (53.50%), Shiroruja (73%), Shotha (91.50%) and significant effect on Hatanala (39.25%) [Table 1].
Group-A provided significant result in Hb gm% (4.36%), RBC (2.67%), PCV (4.19%), MCV (1.49%), serum iron (12.37%), percent transferrin saturation (20.77%) and TIBC (7.18%) whereas insignificant changes were found in MCH (2.38%), and MCHC (0.54%). In Group-C, significant result was found in Hb gm% (11.04%), RBC (3.87%), PCV (10.08%), MCV (5.98%), MCH (7.07%), serum iron (21.35%), percent transferrin saturation (34.13%) and TIBC (8.25%) whereas insignificant change was found in MCHC (1.38%) [Tables [Tables22 and and33].
Urine and stool report of both groups were within normal limit before and after treatment.
Overall therapeutic effects on clinical features: It was revealed that Trikatrayadi Lauha showed marked improvement in 11.77% patients, moderate improvement in 50.00% and mild improvement in 35.29% patients. Fersolate – CM showed marked improvement in 13.64% patients, moderate improvement in 68.18% and mild improvement in 18.18% patients. Thus, the improvement in clinical features in group-A was 97.06% and in standard control group-C, the result was (100%).
Overall therapeutic effect on hemoglobin (gm%) improvement: it was revealed that Trikatrayadi Lauha (group-A) showed good improvement in 8.82% and mild improvement in 20.59% patients. Fersolate – CM (group-C) showed good improvement in 36.36% patients and mild improvement in 27.27% patients. Although group-A (29.41%) showed less percentage improvement in hemoglobin, but in paired ‘t’ test group-A showed highly significant result.
Fersolate –CM showed some adverse effects viz. nausea, salivation, sour belching (hyper acidity), epigastric pain, flatulence, uneasiness, pain abdomen, liquid stool (diarrhoea), vomiting, loss of appetite and constipation whereas Trikatrayadi Lauha had no adverse effects.
Prevalence of female is high than male which may be due to i) insufficient dietary habits ii) social negligence iii) less educated iv) unawareness about receiving extra iron containing diet for their menstrual blood loss. v) world-wide sex incidence toward female is more approximately 72% (nonpregnant 30.20% and pregnant 41.8%). The 31-50 years is the perfect age group for aggravation of Pitta. Perhaps these patients had been doing excessive exercise, improper diet and suffering from mental stress due to their responsibilities for their family and society. Among the married, most of them were women. Its reason may be i) more physical work ii) family responsibility iii) mental stress iv) improper diet v) rapid succession of delivery and vi) history of abortion. Maximum patients were vegetarians whereas nonvegetarians were less. It is because- i) vegetarian predominant area ii) iron is present in less amount in vegetables and it is mainly nonheme iron which is less absorbable.
It is seen that to relieve the signs and symptoms and increase hemoglobin percentage both Trikatrayadi Lauha and Fersolate-CM are effective. Fersolate-CM relives mentioned clinical features by subsiding anemia with increasing hemoglobin level in blood. Trikatrayadi Lauha palliates Dosha and corrects hemoglobin level in blood and ultimately signs and symptoms are reduced. Trikatrayadi Lauha has Kashaya (astringent), Katu (pungent) and Madhura (sweet) Rasa (taste) and it acts as Dipana (appetizer), Pachana (digestive), Srotoshodhaka (channel cleanser), Tridoshaghna (body humour specifier), Raktadhatu Vardhaka (one which increases blood), Rasayana (rejuvenative) and Balya (one which increases strength). Panduhara (one which subsides pallor) effect is present in Haritaki, Shunthi, Lauha and Mandura. Raktavardhaka property is present in Lauha Bhasma and Mandura Bhasma. Iron (Lauha) also present in Amalaki, Musta, honey, and trace amount in ghee. Presence of ascorbic acid (Vitamin C) in Amalaki has a significant effect on iron bioavailability from cereals and pulses in vitro. Musta also contains copper and manganese which may increase iron metabolism and hemoglobin synthesis. Haritaki has ferric-reducing antioxidant activity. Therefore, iron absorption easily happens. Lauha Bhasma and Mandura Bhasma possess significant hematinic and cytoprotective activity. Lauha Bhasma has also hemoglobin regeneration efficacy. Honey and ghee act as Yagovahi (bioenhancer) by which they enhance the medicinal qualities of the preparation and also help them to reach the deeper tissues.
IDA may be covered under Panduroga. In comparison to standard control drug (Fersolate-CM), Trikatrayadi Lauha is effective to relieve the signs and symptoms of panduroga viz. Shrama, Shwasa, Daurbalya, Pandu Varna, Hridspandana, Hatanala, Bhrama, Anna Aruchi, Arohana Ayasa, Shiroruja and Shotha. Trikatrayadi lauha provided significant improvement on Hbgm%, RBC, PCV, MCV, serum iron, percent transferrin saturation and to decrease TIBC. No ADRs would be noticed throughout the course of Trikatrayadi Lauha, may be used in Panduroga or IDA as a safe hematinic drug.