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.
Study Type
OBSERVATIONAL
Enrollment
600
Guangdong Province Hospital of Tradtional Chinese Medicine
Guangzhou, Guangdong, China
RECRUITINGChange 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)
Time frame: From the enrollment to the end of the observation on the 28th day
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 frame: From enrollment to the end of the observation on the 28th day.
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.
Time frame: From the enrollment to the end of the observation on the 28th day.
Time to Viral RNA Clearance (RT-PCR Negative)
Measures the days required for chikungunya virus RNA to become undetectable in blood by RT-PCR.
Time frame: From the enrollment to the end of the treatment on the 5th day.
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 frame: From the enrollment to the end of the treatment on the 5th day.
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Time to Symptom Recovery
Assesses the duration until complete resolution of all symptoms (e.g., fatigue, headache, myalgia).
Time frame: From the enrollment to the end of the observation on the 28th day.
Incidence of Complications
Monitors the occurrence of complications (e.g., chronic arthritis, neurological involvement, secondary infections).
Time frame: From the enrollment to the end of the observation on the 28th day.
Adverse Events (AEs)
Records all AEs (e.g., allergic reactions, gastrointestinal issues) and their relation to the treatment.
Time frame: From the enrollment to the end of observation on the 28th day.
Proportion of participants with normalized C-reactive protein (CRP) levels
Percentage of subjects achieving serum CRP levels within normal reference range (≤5 mg/L)
Time frame: From the enrollment to the end of the treatment on the 5th day.
Proportion of participants with restored baseline-abnormal coagulation parameters
Percentage of subjects achieving normalization in coagulation parameters that were abnormal at baseline (e.g., PT, aPTT, INR, D-Dimer)
Time frame: From the enrollment to the end of the treatment on the 5th day.