Real-World Study on Chinese Medicine for Treating Chikungunya Fever

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorGuangzhou University of Traditional Chinese Medicine

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

600 Participants
are grouped into 3 trial groups
Group A: Chinese Medicine Group
Group B: Western Medicine Group
Group C: Integrated Therapy Group

Trial outcomes

Primary outcomes

1

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)

Time frame
From the enrollment to the end of the observation on the 28th day
2

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.
3

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.

Secondary outcomes

1

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.
2

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.
3

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.
4

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.

Other outcomes

Sponsors and contacts

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