â??Additional Effect of Bhadradi Asthapan with Amrutadya Tail Anuvasan Basti and Kanchanar Guggul in primary hypothyroidism

Phase 2

Conditions: Health Condition 1: E02- Subclinical iodine-deficiency hypothyroidism

Recruitment & Eligibility

Inclusion Criteria

1. Patient having clinical features of hypothyroidism and fulfilling diagnostic criteria of this

study.

2. Patients who are fulfilling the criteria of borderline hypothyroidism (2 to 5), clinical

hypothyroidism (more than 5) according to Zulewskâ??s scale.

3. Patients who are willing to participate in trial and ready to give written consent.

4. Patient having TSH value 4.6- 40mIu/L

5. Patients of either sex, aged between 16-70 years irrespective of caste, religion, socio economic and educational status.

6. Those patients who are fit for Basti as per classics.

7. Patient with controlled HTN (BP Systolic <150 and Diastolic <90 mmHg) and DM having FBS

< 130 mg/dl and PMBS < 200 mg/dl.

Exclusion Criteria

1.Patients who are not willing to participate in trial and not ready to give written consent.

2.Patients having age below 16 years and above 70 years.

3.Patients who has uncontrolled HTN (BP Systolic >150 Diastolic > 90 mmHg), DM (FBS >130

mg/dl and PMBS > 200 mg/dl) or any other systemic illness.

4.Patients who are suffering from congenital hypothyroidism, neoplasia, toxic goitre.

5.Pregnent and lactating ladies.

6.Patients who are currently participating in any other clinical trial from last 6 months.

7. Patients who had undergone any type of Thyroid surgery

8.Patients who are unfit for Basti according to classis.

9.Patients on prolonged medication ( >6 week) with corticosteroids or any drug that may had

an influence on the outcome of study.

Primary Outcome Measures

Name	Time	Method
Assessment (BT) on preceding day on Zulewsks scale <br/ ><br> Deepan-Pachan for 3-5 days <br/ ><br> First assessment on 4th day <br/ ><br> Amrutadya tail Anuvasan basti <br/ ><br>Bhadradi Asthapan Basti <br/ ><br> for 16 days second assessment <br/ ><br> on 17th day Kanchanar Guggul 500 mg-1gm Final assessment after completion <br/ ><br>subsequently for 45 days of treatment (on 45thday) <br/ ><br> <br/ ><br>Timepoint: 45 days <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1.To evaluate the effect of Bhadradi Asthapan Basti with Amrutadya Tail Anuvasan Basti and <br/ ><br>Kanchanar Guggul with levothyroxine in primary hypothyroidism specifically on Billewicz <br/ ><br>diagnostic index. <br/ ><br>2.To evaluate the effect of Bhadradi Asthapan Basti with Amrutadya Tail Anuvasan Basti and <br/ ><br>Kanchanar Guggul with levothyroxine in Primary hypothyroidism specifically on TSH. <br/ ><br>Timepoint: 45 days