A clinical trial to know the effects of LT4/LT3 combination therapy in improving the quality of life & to look for change in body mass index, body weight, lipid profile among adults patients with primary hypothyroidism.
Not Applicable
- Conditions
- Health Condition 1: E038- Other specified hypothyroidism
- Registration Number
- CTRI/2023/06/053860
- Lead Sponsor
- DrBinod Prusty
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All hypothyroid patients aged 18 to 60 years who had been diagnosed with primary hypothyroidism and were on a stable dose of LT4 with serum TSH being normal i.e,(0.35-4.2microIU/ml) for atleast 3months
Exclusion Criteria
1)Pregnant women planning for pregnancy, vitamin D deficiency, any history of renal, hepatic or cardiac dysfunction, hypocortisolemia.
2)Drugs including psychotropic medications, rifampicin, phenytoin, oral contraceptives and study groups patients during any point of study if serum TSH not in normal range.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To assess the effectiveness of LT4/LT3 combination therapy in improving quality of life among adult primary hypothyroidism patients.Timepoint: Baseline <br/ ><br>12 weeks <br/ ><br>24 weeks
- Secondary Outcome Measures
Name Time Method 1.Change in body weight. <br/ ><br>2.Change in Body-mass index. <br/ ><br>3.Change in fasting lipid profile. <br/ ><br>4.Change in Serum TSH, Serum FT4, Serum FT3 , Serum T4, Serum T3. <br/ ><br>5.Change in HbA1C . <br/ ><br>6.Treatment preference. <br/ ><br>Timepoint: Baseline <br/ ><br>12 weeks <br/ ><br>24 weeks