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| ID | Type | Description | Link |
|---|---|---|---|
| MD-MU-IRB-R.24.11.2879 | Other Identifier | Faculty of Medicine, Mansoura University Institutional Review Board, Egypt |
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| Name | Class |
|---|---|
| Saudi German Hospital - Madinah | OTHER |
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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.
Thyroiditis represents a heterogeneous group of inflammatory thyroid disorders. Hashimoto's thyroiditis is characterized by chronic autoimmune-mediated thyroid inflammation and progressive thyroid dysfunction. Subacute thyroiditis commonly presents with painful thyroid enlargement, elevated inflammatory markers, transient thyrotoxicosis, and possible later hypothyroidism.
Current treatment strategies include supportive care, nonsteroidal anti-inflammatory drugs, and corticosteroids. While corticosteroids often provide rapid symptomatic benefit, recurrence after withdrawal and steroid-related adverse effects remain clinically relevant concerns.
Colchicine inhibits microtubule polymerization, leukocyte migration, and inflammasome-mediated signaling. These mechanisms may provide potential benefit in thyroid inflammatory disease.
This prospective three-arm randomized controlled trial will compare colchicine, corticosteroid therapy, and supportive care regarding inflammatory improvement, thyroid function recovery, symptom control, recurrence, and tolerability.
Participants will be randomized in a 1:1:1 ratio and followed for six months. Primary outcomes include changes in C-reactive protein, erythrocyte sedimentation rate, and clinical symptom improvement. Secondary outcomes include thyroid function tests, thyroid autoantibodies, ultrasound improvement, recurrence rate, need for rescue corticosteroid therapy, and adverse events.
This study may help identify an effective steroid-sparing therapeutic strategy for inflammatory thyroid disorders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colchicine | Experimental | 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. |
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| Prednisolone | Active Comparator | 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. |
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| Supportive Care | Active Comparator | Participants will receive standard supportive care including analgesics, NSAIDs if clinically indicated, hydration advice, and monitoring. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| colchicine | Drug | Colchicine administered orally according to the study dosing protocol. Dose adjustments permitted based on tolerability and safety assessment. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in C-Reactive Protein (CRP) | Reduction in serum C-reactive protein concentration compared with baseline among treatment groups. | Baseline, Month 3, Month 6 |
| Mean Change in Erythrocyte Sedimentation Rate (ESR) | Reduction in erythrocyte sedimentation rate compared with baseline among treatment groups. | Baseline, Month 3, Month 6 |
| Mean Change in Thyroid Pain and Inflammatory Symptom from Baseline | Improvement in thyroid pain, neck tenderness, local discomfort, and inflammatory symptoms will be assessed using a standardized Thyroid Pain and Inflammatory Symptom Score ranging from 0 to 10, where higher scores indicate greater symptom severity and lower scores indicate clinical improvement. | Baseline, Month 1, Month 3, Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Serum Thyroid-Stimulating Hormone (TSH) Concentration from Baseline | Assessment of changes in serum thyroid-stimulating hormone (TSH) concentrations compared with baseline values. | Baseline, Month 3, Month 6 |
| Mean Change in Serum Free Triiodothyronine (Free T3) and Free Thyroxine (Free T4) Levels from Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amr A. El Sehrawy, MD, PhD, FRCPE | Contact | +966503845019 | amrsehrawy@mans.edu.eg | |
| Amro A. Elbaz, MD | Contact | +201000191910 | dramrbaz@mans.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Amr A. El Sehrawy, MD, PhD, FRCPE | Faculty of Medicine, Mansoura University | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40203050 | Background | Li Y, Hu Y, Zhang Y, Cheng K, Zhang C, Wang J. Advances in Subacute Thyroiditis: Pathogenesis, Diagnosis, and Therapies. FASEB J. 2025 Apr 15;39(7):e70525. doi: 10.1096/fj.202403264R. | |
| 41704486 | Background | Wang L, Zhu X, Xu S, Zhou B, Wu Y, Li Z, Zhao Y, Li S, Cheng F, Zhu L. Hashimoto's thyroiditis: from pathogenesis to clinical management. Front Endocrinol (Lausanne). 2026 Feb 2;17:1729316. doi: 10.3389/fendo.2026.1729316. eCollection 2026. |
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De-identified individual participant data underlying the results reported in publications will be made available upon reasonable request to the corresponding author, following institutional approval and in accordance with ethical and confidentiality regulations.
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Data will be available beginning 6 months after publication of the primary study results and will remain available for up to 5 years.
Access to the data may be granted to qualified researchers for scientifically valid purposes after review and approval by the responsible institution and study investigators.
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| ID | Term |
|---|---|
| D050031 | Hashimoto Disease |
| D013968 | Thyroiditis, Subacute |
| D013966 | Thyroiditis |
| D013967 | Thyroiditis, Autoimmune |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| D011239 | Prednisolone |
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
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Participants will be randomized in a 1:1:1 ratio to colchicine, prednisolone, or supportive care. Study groups will be followed in parallel for 6 months to assess inflammatory, clinical, and thyroid function outcomes.
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Open-label trial. Participants, care providers, and investigators are aware of assigned interventions due to differences in treatment regimens.
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| Prednisolone | Drug | Prednisolone administered orally according to the study treatment protocol with dose tapering based on clinical response and safety monitoring. |
|
| NSAID | Drug | Non-steroidal anti-inflammatory drugs administered according to standard clinical practice and patient tolerance. |
|
Assessment of changes in serum free triiodothyronine (Free T3) and free thyroxine (Free T4) concentrations compared with baseline values. |
| Baseline, Month 3, Month 6 |
| Mean Change in Serum Thyroid Peroxidase Antibody (TPOAb) and Thyroglobulin Antibody (TgAb) Levels from Baseline | Assessment of changes in serum thyroid peroxidase antibody (TPOAb) and thyroglobulin antibody (TgAb) concentrations to evaluate autoimmune inflammatory activity. | Baseline, Month 6 |
| Change in Thyroid Ultrasound Inflammatory Findings from Baseline | Assessment of changes in thyroid ultrasound characteristics, including gland vascularity, parenchymal heterogeneity, gland enlargement, and inflammatory changes compared with baseline findings. | Baseline, Month 6 |
| Recurrence Rate of Thyroiditis | Number and proportion of participants experiencing clinical or biochemical recurrence of thyroiditis after initial improvement during follow-up. | Any recurrence during 6-month follow-up |
| Need for Rescue Corticosteroid Therapy | Number and proportion of participants requiring rescue corticosteroid treatment because of persistent symptoms, worsening inflammation, or inadequate clinical response. | Throughout 6-month follow-up |
| Adverse Events / Drug Intolerance | Frequency, type, and severity of adverse events or treatment intolerance including gastrointestinal symptoms, hepatic dysfunction, renal impairment, cytopenia, or steroid-related adverse effects. | Baseline to Month 6 |
| 41096157 | Background | Wolowiec L, Osiak-Gwiazdowska J, Jasniak A, Mucha W, Wojtaluk M, Czerniecka W, Wolowiec A, Banach J, Grzesk G. Colchicine in Contemporary Pharmacotherapy: Mechanistic Insights and Clinical Horizons. J Clin Med. 2025 Oct 7;14(19):7078. doi: 10.3390/jcm14197078. |
| Background | Bao RH, et al. Balancing the benefits and risks of colchicine use among patients with coronary heart disease. 2025. Colchicine exerts anti-inflammatory effects through inhibition of microtubule function, suppression of NLRP3 inflammasome activation, and reduction of hs-CRP. |
| Background | Plotz B, et al. New perspectives on the NLRP3 inflammasome: colchicine and suppression of inflammatory pathways in metabolic syndrome-associated diseases. Explor Musculoskeletal Dis. 2025;3:1007104. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011278 |
| Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D018712 | Analgesics, Non-Narcotic |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000893 | Anti-Inflammatory Agents |
| D045506 | Therapeutic Uses |
| D018501 | Antirheumatic Agents |