A Clinical trial to study the effect of Dadimadi gutika in themanagement of Primary Hypothyroidism.

Phase 3

Conditions: Health Condition 1: E038- Other specified hypothyroidism

Registration Number: CTRI/2024/07/070307

Lead Sponsor: R A Podar Govt (Ayu) College,Worli,Mumbai-18

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1) Signs and symptoms of primary hypothyroidism.

2) Newly diagnosed patient of primary hypothyroidism.

3) Subjects who are willing to give written informed consent.

4) Serum TSH level above 5.5µU/ml but below 20 µU/ml.

Exclusion Criteria

1)Any complication arising during the treatment or if any patient discontinuing the treatment will be excluded.

2) Patients having active PR bleeding, active haemorrhoid, fissure in ano, fistula in ano etc.

3) Pregnant and lactating mothers

4) Hypertension, Diabetes Mellitus, Hypothyroidism due to excessive radiation therapy in treating cancer like lymphoma.

5) Malignancy of Thyroid Gland

6) Any other metabolic or systemic disease conditions where other treatment is urgent and was disturb the regimen. (HIV, Diabetes Cardiovascular disease, Tuberculosis etc.)

7) Patient having myxoedema coma.

8) Patients having X-Syndrome, Down’s syndrome, Turner’s syndrome, Klinefelter’s Syndrome carpel tunnel syndrome will be excluded.

9) Patient having Hypothyroidism due to Hypothalamic and Pituitary dysfunction.

10) Present history of any mental disorder.

11)Patient with chronic hyper acidity

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To study the effect of ‘Dadimadi Gutika’ on Agnimandya (poor appetite), <br/ ><br>Shramashwasa (Dysnoea), Daurbalya (weakness), Khalitya (hairloss) etc. <br/ ><br>symptoms of primary hypothyroidism. <br/ ><br>2. To study the effect of Dadimadi Gutika on serum TSH T3, T4 level. <br/ ><br> <br/ ><br>Timepoint: Clinically patients will be screened after every month for 3 months and <br/ ><br>TFT will be done before and after treatment.

Secondary Outcome Measures

Name	Time	Method
1) To review the Ayurvedic & Modern literature on Primary Hypothyroidism. <br/ ><br>2) To correlate Rasadhatvagnimandya, Rasapradoshajanya vyadhi & Primary <br/ ><br>Hypothyroidism. <br/ ><br>3) To asses the possible mode of action of Dadimadi GutikaTimepoint: At 4th 8th & 12th week