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Colchicine for Autoimmune and Subacute Thyroiditis

NCT07571681 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-05-06

No results posted yet for this study

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.

Conditions

  • Hashimoto Thyroiditis
  • Subacute Thyroiditis
  • Thyroiditis

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.

Sponsors & Collaborators

  • Saudi German Hospital - Madinah

    collaborator OTHER

  • Mansoura University

    lead OTHER

Principal Investigators

  • Amr A. El Sehrawy, MD, PhD, FRCPE · Faculty of Medicine, Mansoura University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2027-07-31
Completion
2027-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07571681 on ClinicalTrials.gov