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NCT Number: NCT07120724

Real-World Study on Chinese Medicine for Treating Chikungunya Fever

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.

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Key information

Conditions

Chikungunya Fever Alphavirus Infections Arbovirus Infections Infections Mosquito-Borne Diseases RNA Virus Infections Togaviridae Infections Vector Borne Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Guangdong Province Hospital of Tradtional Chinese Medicine

Guangzhou, Guangdong, 510120, China

Location status: Recruiting

Location contact

Jianwen Guo, MD

PRINCIPAL_INVESTIGATOR

jianwen Guo, Dr

CONTACT

[email protected]

020-81887233 ext. 34530

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

    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)

  2. 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.

    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

  3. Time to Complete Fever Resolution

    Time frame: 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 outcomes

  1. Time to Viral RNA Clearance (RT-PCR Negative)

    Time frame: 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.

  2. Proportion of participants with normalized blood cell counts

    Time frame: 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

  3. Time to Symptom Recovery

    Time frame: 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).

  4. Incidence of Complications

    Time frame: 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).

  5. Adverse Events (AEs)

    Time frame: 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.

  6. 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.

    Percentage of subjects achieving serum CRP levels within normal reference range (≤5 mg/L)

  7. Proportion of participants with restored baseline-abnormal coagulation parameters

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Guangzhou University of Traditional Chinese Medicine

Other

Registry information

Official study title

Efficacy and Safety of Chinese Medicine in the Treatment of Chikungunya Fever: A Real-World Observational Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 13, 2025
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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