Real-World Study on Chinese Medicine for Treating Chikungunya Fever

Recruiting

• Conditions: Chikungunya Fever

• Registration Number: NCT07120724
• Lead Sponsor: Guangzhou University of Traditional Chinese Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-25
• Study Start: 2025-07-26
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-06
• Last Update Submitted: 2025-08-06
• Study First Posted: 2025-08-13
• Last Update Posted: 2025-08-13
• Primary Completion: 2026-07-26
• Study Completion: 2026-12-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Guangdong Province Hospital of Tradtional Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China