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NOT YET RECRUITING
NCT07571681
PHASE2/PHASE3

Colchicine for Autoimmune and Subacute Thyroiditis

Sponsor: Mansoura University

View on ClinicalTrials.gov

Summary

Thyroiditis includes inflammatory thyroid disorders such as Hashimoto's thyroiditis and subacute thyroiditis. These conditions may cause thyroid pain, neck tenderness, elevated inflammatory markers, thyroid dysfunction, fatigue, and recurrence. Current management includes observation, symptomatic treatment, nonsteroidal anti-inflammatory drugs, and corticosteroids. Although corticosteroids may be effective, relapse after tapering and treatment-related adverse effects remain limitations. Colchicine is hypothesized to reduce inflammatory activity and may improve biochemical and clinical recovery. This study will evaluate the efficacy and safety of low-dose colchicine compared with corticosteroid therapy and supportive care in adults with autoimmune or subacute thyroiditis.

Official title: Colchicine as a Novel Anti-Inflammatory Strategy in Autoimmune and Subacute Thyroiditis: A Prospective Three-Arm Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2026-07

Completion Date

2027-09

Last Updated

2026-05-06

Healthy Volunteers

No

Interventions

DRUG

colchicine

Colchicine administered orally according to the study dosing protocol. Dose adjustments permitted based on tolerability and safety assessment.

DRUG

Prednisolone

Prednisolone administered orally according to the study treatment protocol with dose tapering based on clinical response and safety monitoring.

DRUG

NSAID

Non-steroidal anti-inflammatory drugs administered according to standard clinical practice and patient tolerance.