Health TrialsbyHealthPanel

Colchicine for Autoimmune and Subacute Thyroiditis

ConditionsHashimoto ThyroiditisSubacute ThyroiditisThyroiditis
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMansoura University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnancy or breastfeeding

Severe renal impairment

Severe hepatic disease

Cytopenia

Trial design

Design model

Parallel

Treatments tested in this trial

  • colchicine

    Drug

    Colchicine administered orally according to the study dosing protocol. Dose adjustments permitted based on tolerability and safety assessment.

  • 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.

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: ColchicineExperimental treatment 1 intervention
Group B: PrednisoloneActive comparator 1 intervention
Group C: Supportive CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mansoura University

Lead sponsor

Saudi German Hospital - Madinah

Collaborator

Source ClinicalTrials.gov
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