About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
The study participants will be selected from patients affected by the chikungunya fever outbreak in Foshan, Guangdong Province, with current concentration in Shunde District.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Change in Rash Severity Assessed by Modified Eczema Area and Severity Index (mEASI)
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)
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
Records the duration (in hours/days) from treatment initiation until the patient achieves sustained normal body temperature (≤37.3°C) without antipyretics.
Secondary outcomes
Time to Viral RNA Clearance (RT-PCR Negative)
Measures the days required for chikungunya virus RNA to become undetectable in blood by RT-PCR.
Proportion of participants with normalized blood cell counts
Percentage of subjects achieving restoration of white blood cell, lymphocyte and platelet counts to normal reference ranges
Time to Symptom Recovery
Assesses the duration until complete resolution of all symptoms (e.g., fatigue, headache, myalgia).
Incidence of Complications
Monitors the occurrence of complications (e.g., chronic arthritis, neurological involvement, secondary infections).
Sponsors and contacts
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