A Phase 2/3 interventional study of colchicine and Prednisolone in Hashimoto Thyroiditis, Subacute Thyroiditis and Thyroiditis, sponsored by Mansoura University. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Mansoura University · Phase 2/3, Interventional, and Treatment
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.
53 studies on the registry are indexed under Hashimoto Disease; 13 are open to participants now.
This study's planned enrollment of 300 is above the median of 60 across 31 interventional studies indexed under Hashimoto Disease.
Browse Hashimoto Disease studies →Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: colchicine
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.
Drug: Prednisolone
Participants will receive standard supportive care including analgesics, NSAIDs if clinically indicated, hydration advice, and monitoring.
Drug: NSAID
Colchicine administered orally according to the study dosing protocol. Dose adjustments permitted based on tolerability and safety assessment.
Prednisolone administered orally according to the study treatment protocol with dose tapering based on clinical response and safety monitoring.
Non-steroidal anti-inflammatory drugs administered according to standard clinical practice and patient tolerance.
Mean Change in C-Reactive Protein (CRP)
Reduction in serum C-reactive protein concentration compared with baseline among treatment groups.
Time frame: Baseline, Month 3, Month 6
Mean Change in Erythrocyte Sedimentation Rate (ESR)
Reduction in erythrocyte sedimentation rate compared with baseline among treatment groups.
Time frame: 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.
Time frame: Baseline, Month 1, Month 3, Month 6
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.
Time frame: Baseline, Month 3, Month 6
Mean Change in Serum Free Triiodothyronine (Free T3) and Free Thyroxine (Free T4) Levels from Baseline
Assessment of changes in serum free triiodothyronine (Free T3) and free thyroxine (Free T4) concentrations compared with baseline values.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Month 6
Plan to share: Yes — 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.
Time frame: Data will be available beginning 6 months after publication of the primary study results and will remain available for up to 5 years.
Access criteria: 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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Studies of the drug tested here: Colchicine