Colchicine for Autoimmune and Subacute Thyroiditis
Official title: Colchicine as a Novel Anti-Inflammatory Strategy in Autoimmune and Subacute Thyroiditis: A Prospective Three-Arm Randomized Controlled Trial
Run by Mansoura University · NCT07571681 · Data updated 2026-11-12
This study tests whether low-dose colchicine can help people with autoimmune or subacute thyroiditis feel better and recover faster, compared with corticosteroids or standard care.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Mansoura University Academic / other |
| Locations | 2 sites (Al Mansurah, Dakahlia Governorate and 1 other locations) |
| Status | Recruiting |
| Started | June 15, 2026 |
| Main results expected | July 2027 |
| Study ends | September 2027 |
| Registry record updated | July 29, 2026 |
| Trial ID | NCT07571681 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–70 with newly diagnosed Hashimoto’s thyroiditis or subacute thyroiditis who can provide informed consent and meet safety criteria.
✕Probably not a fit
Patients with pregnancy, severe renal or hepatic disease, cytopenia, active serious infection, or recent chronic corticosteroid use may not experience benefit and could be excluded for safety.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, three-arm trial compares colchicine, corticosteroid therapy, and supportive care in adults with autoimmune or subacute thyroiditis. Participants will be followed for six months to assess inflammation markers, thyroid function, symptoms, and safety. Primary outcomes include changes in C-reactive protein, erythrocyte sedimentation rate, and symptom improvement, with several secondary measures such as thyroid tests, ultrasound changes, recurrence, need for additional steroids, and adverse events. The study explores whether colchicine can reduce inflammation and improve clinical recovery while maintaining tolerability. It is conducted at Mansoura University and Saudi German Hospital with adults aged 18 to 70 who have recently been diagnosed.
Why it matters
Potential benefit: If successful, this approach could offer an effective alternative or adjunct to steroids, potentially reducing inflammation and recurrence while minimizing steroid-related side effects.
How similar studies have gone: Previous similar approaches in inflammatory thyroid disorders have shown signals of benefit; this study tests colchicine in a well-controlled randomized setting to establish efficacy and safety.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Pregnancy or breastfeeding * Severe renal impairment * Severe hepatic disease * Cytopenia * Active serious infection * Known hypersensitivity to colchicine * Chronic corticosteroid use within previous 30 days * Participation in another interventional trial * Any condition affecting safety or protocol adherence
Where it's running
-
Mansoura University
Al Mansurah, Dakahlia Governorate, Egypt Recruiting -
Saudi German Hospital
Jeddah, Mecca Region, Saudi Arabia Recruiting
Study contacts
- Study coordinator: Amr A. El Sehrawy, MD, PhD, FRCPE
- Email: amrsehrawy@mans.edu.eg
- Phone: +966503845019
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.