An outdoor based study to see the differences between the effects after morning and evening administration of a drug used in hypothyroidism (thyroid disorder)
Phase 4
- Conditions
- Health Condition 1: E039- Hypothyroidism, unspecifiedHealth Condition 2: E039- Hypothyroidism, unspecified
- Registration Number
- CTRI/2018/09/015773
- Lead Sponsor
- DIPAN SAHA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Patients with primary hypothyroidism, who are drug naïve.
Exclusion Criteria
1.Patients who are already on levothyroxine therapy.
2. Seriously ill patients (such as malignancy etc.)
3. Patients with serious infective diseases (such as TB, AIDS etc.)
4.Pregnant and lactating mothers.
5.Known liver disease, chronic obstructive pulmonary disease and chronic renal disease.
6. Patients on medications (e.g. iron, calcium, proton pump inhibitor, amiodarone, etc) which can interfere with levothyroxine absorption or have an effect on thyroid profile.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method serum T3, T4 and TSH levels <br/ ><br>Adverse drug reactionTimepoint: baseline, after 8 weeks and after 24 weeks
- Secondary Outcome Measures
Name Time Method lipid profile , plasma glucoseTimepoint: baseline, after 8 weeks and after 24 weeks