Colchicine as a Novel Anti-Inflammatory Strategy in Autoimmune and Subacute Thyroiditis: A Prospective Three-Arm Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Mean Change in C-Reactive Protein (CRP)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open-label trial. Participants, care providers, and investigators are aware of assigned interventions due to differences in treatment regimens.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Supportive Care
Participants will receive standard supportive care including analgesics, NSAIDs if clinically indicated, hydration advice, and monitoring.
干预措施: NSAID (Drug)
Prednisolone
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.
干预措施: Prednisolone (Drug)
Colchicine
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.
干预措施: colchicine (Drug)
结局指标
主要结局
Mean Change in C-Reactive Protein (CRP)
时间窗: Baseline, Month 3, Month 6
Reduction in serum C-reactive protein concentration compared with baseline among treatment groups.
Mean Change in Erythrocyte Sedimentation Rate (ESR)
时间窗: Baseline, Month 3, Month 6
Reduction in erythrocyte sedimentation rate compared with baseline among treatment groups.
Clinical Symptom Improvement Score
时间窗: Baseline, Month 1, Month 3, Month 6
Improvement in thyroid pain, neck tenderness, discomfort, and inflammatory symptoms using standardized clinical assessment.
次要结局
- Change in Thyroid-Stimulating Hormone (TSH)(Baseline, Month 3, Month 6)
- Change in Free T3 and Free T4(Baseline, Month 3, Month 6)
- Change in TPOAb and TgAb(Baseline, Month 6)
- Thyroid Ultrasound Improvement(Baseline, Month 6)
- Recurrence Rate of Thyroiditis(Any recurrence during 6-month follow-up)
- Need for Rescue Corticosteroid Therapy(Throughout 6-month follow-up)
- Adverse Events / Drug Intolerance(Baseline to Month 6)