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Colchicine for Autoimmune and Subacute Thyroiditis

Study acronym: COLTHYR
StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Study sites: 0 to 2 · Start date changed from estimate of Jul 2026 to Jun 15, 2026v3 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of Jul 2026 to Jun 15, 2026
  2. Primary endpoint(s) modified Secondary endpoints revised (7)v2 Show 1 more changeShow less
    • Secondary endpoints revised (7)

    See this version in full on ClinicalTrials.gov ↗

  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07571681
Lead Sponsor Mansoura University
Collaborators: Saudi German Hospital - Madinah
Conditions Hashimoto Thyroiditis, Subacute Thyroiditis, Thyroiditis
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov