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Effect of Kanchanar Guggulu and Varunadi Kashaya with and without Virechana in the Management of Hypothyroidism in Adolescents

Phase 3
Conditions
Health Condition 1: E039- Hypothyroidism, unspecified
Registration Number
CTRI/2023/03/051020
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.Individuals of either gender between the age group of 10 - 16 years.

2.Diagnosed cases/new cases of hypothyroidism on the basis of Sr. TSH, T3, and T4 levels.

a.Subclinical hypothyroidism- 5-10µIU/ml with minimal or absence of symptoms

b.Clinical hypothyroidism- > 5 µIU/ml with clinical symptoms

3.Parents giving consent to participate in the study.

Exclusion Criteria

1.Recent thyroid surgery or radioiodine therapy within 1-year of the studyâ??s start date.

2.History or presence of clinically relevant cardiovascular, renal, metabolic, hematological, neurological, psychiatric, systemic, or infectious disease or malignant tumor, hereditary diseases, or syndromes.

3.Severe mental disorder.

4.Recent hospitalization for a major illness or elective surgery within 1-year of the studyâ??s start date

5.Diabetes mellitus type-1 patients.

6.Patient/Parents not willing to participate in the study.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
â?¢To assess the efficacy in reducing the level of TSH.Timepoint: 0th day, 15th day, 60th day and 120th day
Secondary Outcome Measures
NameTimeMethod
â?¢To assess the efficacy in the improvement of clinical features of Hypothyroidism. <br/ ><br>â?¢To assess the efficacy in tapering the dose of levothyroxine. <br/ ><br>â?¢To assess the efficacy in Zulewskis clinical score. <br/ ><br>Timepoint: 0th day, 60th day and 120th day
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