Hashimoto Thyroiditis Clinical Trials

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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Age 18 to 70 years

• Newly diagnosed Hashimoto's thyroiditis or Subacute thyroiditis

• Diagnosis confirmed clinically, biochemically, and ultrasonographically

• Ability to provide written informed consent

Locations
Other Locations
Egypt
Mansoura University
RECRUITING
Al Mansurah
Saudi Arabia
Saudi German Hospital
RECRUITING
Jeddah
Contact Information
Primary
Amr A. El Sehrawy, MD, PhD, FRCPE
amrsehrawy@mans.edu.eg
+966503845019
Backup
Amro A. Elbaz, MD
dramrbaz@mans.edu.eg
+201000191910
Time Frame
Start Date: 2026-06-15
Estimated Completion Date: 2027-09
Participants
Target number of participants: 300
Treatments
Experimental: Colchicine
Participants will receive oral colchicine 0.5 mg twice daily for 12 weeks. Dose reduction to 0.5 mg once daily will be permitted if gastrointestinal intolerance occurs.
Active_comparator: Prednisolone
Participants will receive oral prednisolone 20 mg daily for 14 days, followed by tapering by 5 mg every 1 to 2 weeks according to clinical response.
Active_comparator: Supportive Care
Participants will receive standard supportive care including analgesics, NSAIDs if clinically indicated, hydration advice, and monitoring.
Sponsors
Collaborators: Saudi German Hospital - Madinah
Leads: Mansoura University

This content was sourced from clinicaltrials.gov