Clinical Trials in China / NCT07120724
Recruiting
Observational
Real-World Study on Chinese Medicine for Treating Chikungunya Fever
NCT07120724 · tracked via the Priya Life Science China tracker
Condition(s) studied
Chikungunya Fever
Study summary
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
Inclusion Criteria:
1. Meets the suspected or confirmed diagnostic criteria for chikungunya fever;
2. Symptom onset ≤3 days before enrollment;
3. Actual prescribed treatment aligns with the study's group assignment (TCM, Western medicine, or combined therapy)
4. Signed informed consent form
Exclusion Criteria:
1. Severe chikungunya fever;
2. Participation in another drug clinical trial within the past 3 months;
3. Any other condition deemed by the investigator as unsuitable for enrollment.
Primary outcome measure(s)
- Change in Rash Severity Assessed by Modified Eczema Area and Severity Index (mEASI) — 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) — 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 — 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Guangdong Province Hospital of Tradtional Chinese Medicine | Guangzhou | Guangdong | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07120724 on ClinicalTrials.gov ↗ ← All trials in China