Real-World Study on Chinese Medicine for Treating Chikungunya Fever
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chikungunya Fever. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of Chinese Medicine in the Treatment of Chikungunya Fever: A Real-World Observational Study
Overview
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.
Primary outcome measures
- Change in Rash Severity Assessed by Modified Eczema Area and Severity Index (mEASI) [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) [Time frame: From enrollment to the end of the observation on the 28th day.]
- Time to Complete Fever Resolution [Time frame: From the enrollment to the end of the observation on the 28th day.]
Secondary outcome measures (7)
- Time to Viral RNA Clearance (RT-PCR Negative) [Time frame: From the enrollment to the end of the treatment on the 5th day.]
- Proportion of participants with normalized blood cell counts [Time frame: From the enrollment to the end of the treatment on the 5th day.]
- Time to Symptom Recovery [Time frame: From the enrollment to the end of the observation on the 28th day.]
- Incidence of Complications [Time frame: From the enrollment to the end of the observation on the 28th day.]
- Adverse Events (AEs) [Time frame: From the enrollment to the end of observation on the 28th day.]
- Proportion of participants with normalized C-reactive protein (CRP) levels [Time frame: From the enrollment to the end of the treatment on the 5th day.]
- Proportion of participants with restored baseline-abnormal coagulation parameters [Time frame: From the enrollment to the end of the treatment on the 5th day.]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Guangdong Province Hospital of Tradtional Chinese Medicine — Guangzhou
Identifiers
NCT: NCT07120724 · ZE2025-299-01