Assessment of efficacy and safety of Thyroxine Sodium in Indian Patients with Primary Hypothyroidism
Phase 4
Completed
- Conditions
- Health Condition 1: E038- Other specified hypothyroidism
- Registration Number
- CTRI/2019/03/018181
- Lead Sponsor
- Dr Faraz Farishta
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Treatment naïve patients newly diagnosed with primary hypothyroidism
2. Patient with TSH level >10 mIU/L
3. Patients with fT4 level < 0.8 ng/dl
4. Patients willing to participate in the study, sign the Informed Consent Form (ICF) and ready to comply with protocol requirements
Exclusion Criteria
1. Patients with primary hypothyroidism who are already on treatment with thyroxine for more than a month
2. Pregnant and/or lactating women
3. Patients with any acute or chronic cardiac or any other systemic illness that in the opinion of the investigator does not justify the patientâ??s inclusion in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1 Number and percentage of patients with normalization in TSH & fT4 levels over a period of 180 days (6 months)Timepoint: Baseline (Day 0) <br/ ><br>45 days <br/ ><br>90 days <br/ ><br>180 days
- Secondary Outcome Measures
Name Time Method 1. To evaluate the effectiveness of thyroxine sodium in improving Zulewski score at 45, 90 and 180 days, compared to baseline <br/ ><br>2. To evaluate the pattern of dose modification of thyroxine sodium at 45 and 90 days <br/ ><br>3. To determine compliance to treatment with thyroxine sodium in patients with primary hypothyroidismTimepoint: Baseline (Day 0) <br/ ><br>45 days <br/ ><br>90 days <br/ ><br>180 days