A Clinical study evaluating safety, tolerability, and efficacy of Liothyronine tablets in the patients suffering from thyroid gland hormone deficiency.

Phase 4

• Conditions: Health Condition 1: E00-E07- Disorders of thyroid gland

• Registration Number: CTRI/2023/04/051818
• Lead Sponsor: Acme Generics Pvt. Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Hypothyroid patients having persistent complaints, despite adequate treatment with L-T4 as evident from normalization of TSH, free T4 and T3 concentrations.

Exclusion Criteria

1. pregnancy,

2. central hypothyroidism

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety assessment includes Treatment Emergent Adverse Events (TEAEs) assessment <br/ ><br>during the studyTimepoint: baseline, week 2, week6, and week 12 plus 01 month

Secondary Outcome Measures

Name	Time	Method
Percentage Change of clinical signs and symptoms from Baseline using scoring over Quality of Life Questionnaire <br/ ><br> Mean change in Thyroid Function Test values from baseline to at the end of week 12Timepoint: Screening Baseline, week 2, week 6 and week 12 plus 01 month