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An outdoor based study to see the differences between the effects after morning and evening administration of a drug used in hypothyroidism (thyroid disorder)

Comparative study on efficacy and safety of morning dose versus evening dose of Levothyroxine in Treatment of Hypothyroidismâ??An OPD based prospective interventional study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/09/015773
Enrollment
150
Registered
2018-09-20
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E039- Hypothyroidism, unspecified Health Condition 2: E039- Hypothyroidism, unspecified

Interventions

Intervention1: Levothyroxine morning dose: levothroxine tablet will be given according to biochemical parameters and body weight. Control Intervention1: Levothyroxine evening dose: Efficacy of levothr

Sponsors

DIPAN SAHA
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients with primary hypothyroidism, who are drug naïve.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
serum T3, T4 and TSH levels Adverse drug reactionTimepoint: baseline, after 8 weeks and after 24 weeks

Secondary

MeasureTime frame
lipid profile , plasma glucoseTimepoint: baseline, after 8 weeks and after 24 weeks

Countries

India

Contacts

Public ContactDr Dipan Saha

Midnapore Medical College

ram.narayan.maiti@gmail.com9434024681

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026