A clinical study, to compare the effect of two ayurvedic medicines (Shothkalanal ras and Punarnvastak kwath) to treat Primary Hypothyroidism.

Phase 3

• Conditions: Health Condition 1: - Health Condition 2: - Health Condition 3: E039- Hypothyroidism, unspecifiedHealth Condition 4: E039- Hypothyroidism, unspecifiedHealth Condition 5: E039- Hypothyroidism, unspecified

• Registration Number: CTRI/2023/04/051967
• Lead Sponsor: R. A. Podar Ayurved Medical College

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1)Age between 18-50 years25(much variations have been found in normal values of Thyroid profile below18 and above 50 yrs of age)26

2)Elevated level of Serum TSH - 5.0 µU/ml to 15 µU/ml

(Normal value 0.4 to 5.0 µU/ml SI Units 0.4-5.0mU/L)27

3)Low serumT3- Less than 77 ng / dl or in normal range. (no specific range defined for below normal)

(Normal value 77 to 135 ng /dl SI Units 1.2-2.1 nmol /L)27

4)Low serum T4 Less than 5.4 µg/dl, (no specific range defined for below normal)

(Normal value 5.4 to 11.7 µg/dl SI Units70- 151nmol/L)27

Exclusion Criteria

1)Age below 18 and above 50 years (much variations have been found in normal values of Thyroid profile below18 and above 50 yrs of age)26

2)Patients suffering from goitre (Enlarged thyroid gland)

3)Drug induced Hypothyroidism

4)Major Systemic illness likeTuberculosis.

5)Any CNS disorder e.g. encephalopathy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br/ ><br>Efficacy of Sothkalanal ras in the management of Primary Hypothyroidism. <br/ ><br>Efficacy of Punarnavastak kwath in the management of Primary Hypothyroidism. <br/ ><br>Timepoint: <br/ ><br>4 months

Secondary Outcome Measures

Name	Time	Method
Side effects of trial drugs in long term use. <br/ ><br>Reappearance of symptoms of Primary Hypothyroidism, if any after follow up.Timepoint: <br/ ><br>Total clinical study period with follow up 8 months. <br/ ><br>