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

An Open-label, Prospective, Single-arm, Non-comparative, Multi-centric, Phase-IV Clinical Trial evaluating safety, tolerability and efficacy of Liothyronine 5 mcg & 20 mcg tablets in the management of thyroid deficiency.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/04/051818

Enrollment

100

Registered

2023-04-20

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-18

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

Conditions

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

Interventions

Intervention1: Combination of Levothyroxine tablets and Liothyronine tablets (LT-4 plus LT-3): The study is of non-comparative design. The study aims to evaluate the customization of combination of Le

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. pregnancy, 2. central hypothyroidism

Design outcomes

Primary

Measure	Time frame
Safety assessment includes Treatment Emergent Adverse Events (TEAEs) assessment during the studyTimepoint: baseline, week 2, week6, and week 12 plus 01 month	—

Secondary

Measure	Time frame
Percentage Change of clinical signs and symptoms from Baseline using scoring over Quality of Life Questionnaire 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	—

Countries

India

Contacts

Public ContactMr Viral Shah

Inquest Bio-Pharm Private Limited

kapil@inquestbp.com91-8238513462

Outcome results

None listed

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