Use of Dashanga Guggulu and Kansa Haritaki Avaleha in Hypothyroidism along with obesity

Phase 3

Completed

• Conditions: Other specified hypothyroidism. Ayurveda Condition: MEDOVRUDDHIH,

• Registration Number: CTRI/2022/04/041577
• Lead Sponsor: Institute of teaching and research in Ayurveda Jamnagar

Brief Summary

The title of our research project is “**Efficacy of *Dashanga Guggulu & Kansa Haritaki Avaleha* as addon 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* predominantdiet, 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 by22.58%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*.

 Ã˜  **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/mLwhile 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.

 Â§  **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* increasesthe 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.

 Â§  **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 a*nd *Shothagna* properties according to Bhavaprakasha. It has antibacterial, antifungal, antistress, hypotensive, hypolipidemic, purgative, cytoprotective and cardiotonic properties.

 Â§  **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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-05
• Study Completion: 2023-05-23
• Last Update Posted: 2023-11-10

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

i.Patients having clinical features of Hypothyroidism and S.TSH level above >4.25mIU/mL and having BMI≥25kg/m2 ii.Age 18-60 years of either sex iii.Patient willing to give their consent to participate in the study.

Exclusion Criteria

i.Patients suffering from Secondary Hypothyroidism, Hashimoto thyroiditis ii.Chronicity of hypothyroidism more than 10 year iii.Pregnancy, lactating mothers iv.Patients having associated diseases like ischemic heart diseases, uncontrolled hypertension(160/100 mm of Hg), uncontrolled diabetes(RBS>200mg/dl), myocardial infarction, cerebrovascular events, cardiac arrhythmias, malignancy and suffering from psychosis v.Patients age below 18 years and above 60 years of either sex.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in Serum.TSH level	On 0 day and after 6 weeks

Secondary Outcome Measures

Name	Time	Method
i.Improvement in signs & symptom of hypothyroidism	ii.Reduction in weight

Trial Locations

Locations (1)

Institute of teaching and research in Ayurveda Jamnagar; 🇮🇳 Jamnagar, GUJARAT, India

Institute of teaching and research in Ayurveda Jamnagar

🇮🇳Jamnagar, GUJARAT, India

Manisha Gupta

Principal investigator

9294677501

manigupta2608@gmail.com