Health Condition 1: E038- Other specified hypothyroidism
Conditions
Interventions
Intervention1: Thyroxine Sodium tablets: Thyroxine will be administered as a single daily dose, preferably one-half to one-hour before breakfast. Each patient will take an initial oral dose of 1.7mcg/
Sponsors
Dr Faraz Farishta
Eligibility
Inclusion criteria
Inclusion criteria: 1. Treatment naïve patients newly diagnosed with primary hypothyroidism 2. Patient with TSH level >10 mIU/L 3. Patients with fT4 level 4. Patients willing to participate in the study, sign the Informed Consent Form (ICF) and ready to comply with protocol requirements
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Number and percentage of patients with normalization in TSH & fT4 levels over a period of 180 days (6 months)Timepoint: Baseline (Day 0) 45 days 90 days 180 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the effectiveness of thyroxine sodium in improving Zulewski score at 45, 90 and 180 days, compared to baseline 2. To evaluate the pattern of dose modification of thyroxine sodium at 45 and 90 days 3. To determine compliance to treatment with thyroxine sodium in patients with primary hypothyroidismTimepoint: Baseline (Day 0) 45 days 90 days 180 days | — |
Countries
India
Contacts
Public ContactDr Faraz Farishta
F S Endocrine and diabetes center
Outcome results
None listed