The title of our research project is “Efficacy of Dashanga Guggulu & Kansa Haritaki Avaleha as add on in the management of Hypothyroidism associated with obesity - A Standard Controlled Single Blind Clinical Trial

·       Among the 31 patients enrolled in the study, maximum no. of patients i.e. 35.50% belonged to the age group of 41-50 years followed by 29% patients belonged to 18-30 years. The majority of the patients were females (93.55%) while the remaining were males (6.45%) and maximum (80.65%) of patients were Hindus whereas 19.35% were Muslim. Maximum numbers of patients i.e. 90.32% were married.

·       32.26% of patients were reported with graduate education, 25.81% with higher secondary education; maximum (74.20%) patients were housewives. Maximum i.e. 70.97% patients belonged to middle-class section of the society followed by 16.13% patients who belonged to lower middle class; 70.97% patients belonged to urban area and 29.03% patients were from rural area.

·       Observations on chief complaints of hypothyroidism showed that fatigue was present in 100% patients followed by weight gain in 93.55% patients, lethargy in 87.10% patients, breathlessness on exertion and weakness in 77.42% each of patients, muscle ache in 67.74% patients, puffiness of face and eyelids in 61.29% patients, constipation in 54.84%, dry & coarse skin in 32.26%, bilateral peripheral oedema in 25.81% and hoarseness of voice in 12.90% patients.

·       In associated complaints, hairloss was present in all the patients (100%), mood swings in 80.64%, poor concentration in 77.42% and irregular menstruation was present in 9.68% patients.

·       9.68% patients showed positive family history of hypothyroidism. 51.61% patients had chronicity between more than 1 year and less than 5 years, 32.26% had chronicity of more than 5 year while 16.13% had chronicity of less than 1 year. Maximum i.e. 67.74% patients had sudden onset of disease while 32.26% patients had gradual onset.

·       48.39% patients had S.TSH in the range of 10-50 µIU/ml, 45.16% patients had S.TSH in the range of 4.45-10 µIU/ml while 6.45% patients had S.TSH in the range of 50-100 µIU/ml. 58.07% patients were taking <50 mcg of levothyroxine, 19.35% were taking 100 mcg of levothyroxine, 16.13% were taking >100 mcg whereas 6.45% were taking 75 mcg of levothyroxine once in early morning.

·       Maximum no. of patients i.e. 48.39% patients had overweight (BMI- 25-29.9), 25.81% patients were obese grade â…  (BMI- 30-34.9) while 19.35% patients were obese grade â… â…  (BMI- 35.0-39.9) and remaining 6.45% patients were obese grade â…¢ (BMI-Above 40).

·       On analysis of lipid profile, maximum i.e. 29.03% patients had S. LDL>100 mg/dl, 25.81% patients had S. cholesterol >200 mg/dl while 22.58% patients had S. triglycerides >150 mg/dl, 19.35% patients had S. VLDL >30 mg/dl and 16.13% patients were observed with S. HDL <40 mg/dl.

·       In present study, 67.74% of patients were vegetarian while 32.26% patients were taking mixed diet. 61.29% patients had habit of Samashana, 54.84% patients had habit of Vishamashana while 48.39% patients were taking Viruddhashana and 38.31% patients were doing Adhyashana.

·       Majority of the patients i.e. 77.42% had habit of taking Amla Rasa dominant diet followed by 61.29% patients who had Madhura Rasa dominant diet. 100% of patients were taking Guru Guna predominant diet, 83.87% Snigdha Guna diet followed by 54.84% Abhishyandi Guna diet.

·       67.74% of patients had the habit of Diwaswapna (day sleep), 64.52% had the habit of Avyayama while 51.61% of patients had a habit of withholding natural urge (Purisha Vegasandharana) & doing no physical activity. 67.74% of patients had a habit of doing Chinta (stress) while 48.39% of patients had habit of anger (Krodha). Most of the patients enrolled in the study were not having any addictions i.e. 64.52%, 19.35% patients had addiction of tea and 12.90% patients had addiction of tobacco. 74.20% patients had Samyaka Nidra followed by 22.58% patients who had Khandita Nidra.

·       In the present study, 48.39% of patients had Mandagni while 45.16% of patients were possessing Vishamagni and remaining 6.45% of patients were possessing Tikshagni. 54.84% patients had Krura Koshtha followed by 38.71% had Madhyama Koshtha and 6.45% patients had Mridu Koshtha.

·       In Dashavidha Pariksha, majority of the patients i.e 35.48% had Vata-Pittaja Prakriti followed by 32.26% patients who had Kapha-Pittaja and Kapha-Vataja Prakriti. Maximum 77.42% were having Madhyama Samhanana, 80.65% of the patients were of Madhyama Pramana, 87.10% of the patients has Madhyama Satmya and 67.74% were found to be of Madhyama Satva. Majority (51.61%) patients had Madhyama Abhyavarana Shakti, 83.87% patients had Madhyama Jarana Shakti and 64.52% patients had Madhyama Vyayama Shakti.

·       In present study, 100% patients had Rasavaha and Medovaha Srotodushti while 77.42% patients had Mamsavaha Srotodushti whereas 51.69% patients had Swedavaha Srotodushti and 48.39% patients had Purishvaha Srotodushti.

Ø  Effect of therapy:

·       In chief and associated complaints, in group A, breathlessness on exertion was relieved by 66.67%, fatigue by 65% while hairloss was decreased to 38.89% and mood swings decreased by 57.14% which was statistically highly significant. Significant relief was found in puffiness of face by 67%, weakness by 53.33%, lethargy by 63.16%, muscle ache by 63.16%, constipation by 93.33% and poor concentration improved by 40%. Insignificant results were found in bilateral peripheral oedema, dry and coarse skin and irregular menstruation. In Group B, in the present study, significant relief was found in fatigue and poor concentration which was 25.64% and 10.53% respectively. Constipation was relieved by 37.5%, dry and coarse skin was relieved by 33.33%, 16.67% relief was observed in breathlessness while mood swings, lethargy and bilateral peripheral oedema was reduced by 11.76%, 10% and 10% respectively which were statistically insignificant.

On comparing the effect of therapies, highly significant difference was observed in breathlessness, fatigue, mood swings and hairloss and significant difference was observed in constipation, weakness, lethargy, muscle ache, poor concentration and in puffiness of face and eyelids in between the groups. Hence, group A was more effective in these symptoms than group B.

·       In group A, Abhyavarana Shakti was increased by 58.33% Jarana Shakti increased by 41.67% and Ruchi Aharkale by 88.89% which was statistically significant. In Group B, Abhyavarana Shakti was increased by 30%, Jarana Shakti by 19.048% and Ruchi Aharkale showed no change. On statistical analysis, these were found statistically insignificant. On comparing the effect of therapies in present study, highly significant difference was found in Ruchi Aharkale while insignificant in Abhyavarana Shakti and Jarana Shakti but also on the basis of percentage change, group A was more effective in increasing Agnibala.

·       In group A, Quality of life was improved by 38.60% and in group B, Quality of life was improved by 8.62% both of which was statistically highly significant. On comparison, highly significant difference was found and on the basis of percentage change, group A was more effective in improving quality of life.

·       In objective parameters, in group A, S.TSH was decreased by 43.38% which was statistically significant while FT4 was increased by 11.26% but was statistically insignificant. In group B, S.TSH decreased by 30.35% which was statistically significant while FT4 was increased by 18.65% and was statistically insignificant. On comparison, difference in between the groups was statistically insignificant in decreasing S.TSH level and in increasing Free T4 level.

·       Changes in all the biochemical parameters were statistically insignificant in both the groups but remained within normal limits before and after the treatment.

·       In group A, body weight and BMI was decreased by 2.79% and 2.83% respectively which was statistically highly significant. In group B, body weight and BMI was decreased by 0.20% and 0.202% respectively which was statistically insignificant. The difference in between the groups was statistically highly significant in decreasing body weight and BMI. Therefore, it was inferred that group A was more effective on body weight and BMI.

·       In group A, 3 patients had normal (0.38-4.31) S.TSH, 6 patients had S.TSH level in the range 4.31-10 µIU/mL while 6 patients had S.TSH level in the range of 10-50 µIU/mL after the completion of treatment. In group B, 8 patients had S.TSH level in the range 4.31-10 µIU/mL, 5 patients had S.TSH level in the range of 10-50 µIU/mL, 1 patient had S.TSH level 50-100 µIU/mL while 1 patient had S.TSH level of < 0.38 µIU/mL.

·       100% patients had positive drug history. In group A, after the completion of trial, 73.33% patients had continued same dose of levothyroxine, 20% patients had reduction in levothyroxine dose while 6.66% patient had withdrawn their hormonal replacement therapy. In group B, after the completion of trial, 93.33% patients had continued same dose of levothyroxine, 6.67% patients had reduction in levothyroxine dose.

·       So, when patients of hypothyroidism in group A were treated with Kansa Haritaki Avaleha and Dashanga Guggulu, breathlessness, puffiness of face and eyelids, constipation, S.TSH, weakness, lethargy, fatigue, weight gain, hairloss, mood swings and BMI, parameters were statistically significantly reduced and was comparatively better than the effect provided by group B where only thyroxine tablet was given.

     This indicates that only thyroxine replacement therapy is not sufficient in many cases of hypothyroidism where patients even after taking thyroxine have multiple complaints and increased S.TSH. In such cases, metabolic stimulating drugs like Kansa Haritaki Avaleha and Dashanga Guggulu can be added, that can help in breaking pathology of disease and not only bring change in hormonal profile but also can reduce weight, relieve symptoms and improve quality of life.

§  Probable mode of action of Dashanga Guggulu

Ø  Dashanga Guggulu contain Katu, Tikta, Kashaya Rasa which are responsible for KaphaVata Shamana. Laghu, Ruksha, Teekshna Guna and Ushna Veerya which acts Deepana, Pachana, Lekhana, helps in digestion of Ama, removes Srotorodha and improves Agni.

Ø  Triphala has an anti-oxidant property and stimulates digestion. It decreases total cholesterol, triglycerides and low-density lipoprotein cholesterol. According to Acharya Charaka, Triphala has Rasayana property. Trikatu is Agnideepaka, Amapachaka and has Kaphamedahara properties. Pippali increases the absorption of selenium whose deficieny can impair thyroid function because conversion of T4 into T3 is catalysed by specific selenoproteins. Guggulu is the best Vatahara and Medohara as per Ashtanga Sangraha and have thyroid stimulating property and support healthy thyroid function. It also increases iodine uptake along with hypocholestrogenic property.

§  Probable mode of action of Kansa Haritaki Avaleha

Ø  Kansa Haritaki Avaleha having Katu, Tikta, Kashaya Rasa, Laghu, Ruksha, Teekshna Guna, Ushna Virya which does Srotoshodhana by expelling out Ama and Kapha and clear the channels, improves Agni thus helps in breaking further pathogenesis of disease. It possesses Deepana, Anulomana, Rasayana, Shothaghna, Medohara antioxidant, anti-inflammatory, hypolipidemic properties.

Ø  As per Acharya Sushruta, Dashamoola is Kaphapittaanilapaha and Aampachaka. Haritaki has Deepana, Anulomana, Rasayana and Shothagna properties according to Bhavaprakasha. It has antibacterial, antifungal, antistress, hypotensive, hypolipidemic, purgative, cytoprotective and cardiotonic properties.

§  Adverse drug reaction

No adverse effect was observed in patients during the clinical trials. This shows that both formulations Kansa Haritaki Avaleha and Dashanga Guggulu are quite safe for internal administration and can also be given as add on treatment to thyroxine dependent cases of hypothyroidism with obesity.