Real-World Study on Chinese Medicine for Treating Chikungunya Fever

NCT07120724 | Recruiting DMC

• 1 other identifier: ZE2025-299-01
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Chikungunya Fever

Outcome Measures

Primary Outcomes (3)

• 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)

  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

  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.

  From the enrollment to the end of the observation on the 28th day.

Secondary Outcomes (7)

• Time to Viral RNA Clearance (RT-PCR Negative)

  From the enrollment to the end of the treatment on the 5th day.

• Proportion of participants with normalized blood cell counts

  From the enrollment to the end of the treatment on the 5th day.

• Time to Symptom Recovery

  From the enrollment to the end of the observation on the 28th day.

• Incidence of Complications

  From the enrollment to the end of the observation on the 28th day.

• Adverse Events (AEs)

  From the enrollment to the end of observation on the 28th day.

Study Arms (3)

Chinese Medicine Group

Intervention: Patients receive only TCM treatments, which may include herbal formulas (e.g., decoctions, granules) or acupuncture, tailored to their syndrome differentiation (e.g., heat-clearing, detoxifying, or dampness-resolving therapies).

Western Medicine Group

Intervention: Patients receive only standard Western medical care, which may include antipyretics (e.g., acetaminophen), NSAIDs for pain, and supportive treatments (e.g., hydration).

Integrated Therapy Group

Intervention: Patients receive both Chinese and Western treatments.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou University of Traditional Chinese Medicine: lead

Study Sites (1)

Guangdong Province Hospital of Tradtional Chinese Medicine

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Chikungunya Fever

Condition Hierarchy (Ancestors)

Alphavirus Infections; Arbovirus Infections; Vector Borne Diseases; Infections; Mosquito-Borne Diseases; Virus Diseases; Togaviridae Infections; RNA Virus Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 13, 2025
• Study Start: July 26, 2025
• Primary Completion (Estimated): July 26, 2026
• Study Completion (Estimated): December 26, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-08

Locations

CN (1)