Efficacy and Safety of Chinese Medicine in the Treatment of Chikungunya Fever: A Real-World Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Change in Rash Severity Assessed by Modified Eczema Area and Severity Index (mEASI)
研究概览
简要总结
This study aims to evaluate the effectiveness and safety of Chinese Medicine-used alone or combined with Western medicine-in treating chikungunya fever, a mosquito-borne viral disease causing fever, rash, and severe joint pain. With recent outbreaks in China (including over 3,000 cases in Foshan, Guangdong) and no specific antiviral treatment available, Chinese medicine may offer a valuable therapeutic option based on its symptom-relief and syndrome-specific approach.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets the suspected or confirmed diagnostic criteria for chikungunya fever;
- •Symptom onset ≤3 days before enrollment;
- •Actual prescribed treatment aligns with the study's group assignment (TCM, Western medicine, or combined therapy)
- •Signed informed consent form
排除标准
- •Severe chikungunya fever;
- •Participation in another drug clinical trial within the past 3 months;
- •Any other condition deemed by the investigator as unsuitable for enrollment.
结局指标
主要结局
Change in Rash Severity Assessed by Modified Eczema Area and Severity Index (mEASI)
时间窗: From the enrollment to the end of the observation on the 28th day
Quantifies absolute change from baseline in skin inflammation severity using a modified Eczema Area and Severity Index (mEASI) scoring system.(Higher scores indicate more severe inflammation)
Proportion of Participants Achieving Clinically Significant Improvement in Joint Symptoms Assessed by Disease Activity Score 44 (DAS44)
时间窗: From enrollment to the end of the observation on the 28th day.
Measured by the Disease Activity Score 44 (DAS44) scale, which evaluates: * 44 swollen joint counts * 44 tender joint counts * Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP) * Patient's global health assessment (VAS 0-100 mm) Scoring range: 0-10 * Lower scores indicate better disease control * Clinically significant improvement defined as: * 1.2 point reduction from baseline AND Final DAS44 score ≤3.2
Time to Complete Fever Resolution
时间窗: From the enrollment to the end of the observation on the 28th day.
Records the duration (in hours/days) from treatment initiation until the patient achieves sustained normal body temperature (≤37.3°C) without antipyretics.
次要结局
- Proportion of participants with normalized blood cell counts(From the enrollment to the end of the treatment on the 5th day.)
- Proportion of participants with restored baseline-abnormal coagulation parameters(From the enrollment to the end of the treatment on the 5th day.)
- Time to Symptom Recovery(From the enrollment to the end of the observation on the 28th day.)
- Time to Viral RNA Clearance (RT-PCR Negative)(From the enrollment to the end of the treatment on the 5th day.)
- Incidence of Complications(From the enrollment to the end of the observation on the 28th day.)
- Adverse Events (AEs)(From the enrollment to the end of observation on the 28th day.)
- Proportion of participants with normalized C-reactive protein (CRP) levels(From the enrollment to the end of the treatment on the 5th day.)