COMPARATIVE STUDY OF AYURVEDIC FORMULATIONS IN HYPOTHYROIDISM

Phase 2

Conditions: Health Condition 1: E888- Other specified metabolic disorders

Registration Number: CTRI/2021/08/035797

Lead Sponsor: Patanjali Ayurveda College

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Diagnosed patients of Hypothyroidism on the basis of serum TSH, T3, T4 levels. TSH value: > 4.5mIU/ml - < 30mIU/ml. , T3 value: less than or equal to their respective normal range (4.5 â?? 12.5 micro g/dl)

T4 value: less than or equal to their respective normal range (80-220 micro g/dl)

2. Patients within the age group of 18-60 years will be selected

3. Patients irrespective of sex, religion, occupation and chronicity will be selected for the study

4. Both fresh and treated case would be taken for the study

5. Weight gain or unable to lose weight

6. Oligomennorrhea / menorrhagia

Exclusion Criteria

1. Patient ages <18years or >60years will be excluded

2. Pregnant or lactating women will be excluded

3. Patients with severe complications viz. CAD, 4. CHF,CRF, MI will be excluded

5. Patients having tuberculosis, malignancy and any congenital anomaly will not be taken

6. Uncontrolled Diabetes Mellitus and Uncontrolled Hypertension will be excluded

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective Parameter - <br/ ><br>TFT (TSH,T3,T4) <br/ ><br>Subjective Parameter - <br/ ><br>1. Puffiness of Face and eyelids <br/ ><br>2. Dry and course skin <br/ ><br>3. Cold intolerance <br/ ><br>4. Hoarseness of voice <br/ ><br>5. Hair Fall <br/ ><br>6. Fatigue <br/ ><br>7. Breathlessness <br/ ><br>8. Oedema <br/ ><br>9. Weakness <br/ ><br>10. Weakness <br/ ><br>11. Muscle ache <br/ ><br>12. Anorexia <br/ ><br>13. Excessive sleep <br/ ><br>14. Constipation <br/ ><br>15. Weight <br/ ><br>16. Body Mass Index (BMI) <br/ ><br>17. Mentrual Abnormality (Females)Timepoint: Before intervention of jalakumbhi bhasma with or without yavakshar, pippali churna and shigru patra kwath

Secondary Outcome Measures

Name	Time	Method
Objective Parameter <br/ ><br>TFT (TSH,T3,T4) <br/ ><br>Subjective Parameter - <br/ ><br>1. Puffiness of Face and eyelids <br/ ><br>2. Dry and course skin <br/ ><br>3. Cold intolerance <br/ ><br>4. Hoarseness of voice <br/ ><br>5. Hair Fall <br/ ><br>6. Fatigue <br/ ><br>7. Breathlessness <br/ ><br>8. Oedema <br/ ><br>9. Weakness <br/ ><br>10. Weakness <br/ ><br>11. Muscle ache <br/ ><br>12. Anorexia <br/ ><br>13. Excessive sleep <br/ ><br>14. Constipation <br/ ><br>15. Weight <br/ ><br>16. Body Mass Index (BMI) <br/ ><br>17. Mentrual Abnormality (Females)Timepoint: After intervention of jalakumbhi bhasma with or without yavakshar, pippali churna and shigru patra kwath