Clinical trial for management of metabolic manifestations of Primary hypothyroidism patients due to Ras dushti.

Phase 3

Conditions: Health Condition 1: PCS-

Registration Number: CTRI/2024/07/070483

Lead Sponsor: All India institute of Ayurveda

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Patient taking low dose of conventional medicine (up to 50 mcg) (Stratification as per dose will be done to observe the effect in different doses of conventional medicine i.e. thyroxine).

2. Adults of age group 18 to 50 year irrespective of race, gender, religion, caste, occupation, education.

3. Patients who are willing to give written consent.

4. Patients with 1 year of chronicity of disease (including recurrence).

5. Patients with classical signs and symptoms of disease. (as per ICD 10 E03.9) [Decreased basal metabolic rate, fatigue and lethargy, sensitivity to cold, and menstrual disturbances; untreated it progresses to myxedema weight gain, constipation and dry skin.]

Exclusion Criteria

1. Patients who are under high dose (i.e. 75mcg or more) of Conventional Medications because those patients may need additional intervention along with the trial drug to achieve satisfactory result in short duration of trial.

2. Individuals with other comorbidities like hypertension, diabetes mellitus, epilepsy, tuberculosis, carcinoma, and any other severe illness.

3. Patients with thyroiditis and postoperative Primary hypothyroidism.

4. Pregnant , postpartum and lactating women.

5. Individuals who have undergone Panchakarma procedures.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1)Assessment of effect of treatment on TSH , T3 and T4 will be assessed before treatment, after completion of trial and after Follow up. <br/ ><br> <br/ ><br>2) Assessment of effect of treatment on metabolic manifestations of Primary hypothyroidism ,as mentioned above will be assessed by prepared questionnaire and on Day 0 i.e. before initiation of treatment, 15th Day, 30th Day i.e. after completion of trial and after follow up i.e. 60 days <br/ ><br>Timepoint: 1)Assessment of effect of treatment on TSH , T3 and T4 will be assessed before treatment, after completion of trial and after Follow up. <br/ ><br> <br/ ><br>2) Assessment of effect of treatment on metabolic manifestations of Primary hypothyroidism ,as mentioned above will be assessed by prepared questionnaire and on Day 0 i.e. before initiation of treatment, 15th Day, 30th Day i.e. after completion of trial and after follow up i.e. 60 days <br/ ><br>

Secondary Outcome Measures