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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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:
Scoring range: 0-10
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Viral RNA Clearance (RT-PCR Negative) | Measures the days required for chikungunya virus RNA to become undetectable in blood by RT-PCR. | From the enrollment to the end of the treatment on the 5th day. |
| Proportion of participants with normalized blood cell counts |
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Inclusion Criteria:
Exclusion Criteria:
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The study participants will be selected from patients affected by the chikungunya fever outbreak in Foshan, Guangdong Province, with current concentration in Shunde District.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Province Hospital of Tradtional Chinese Medicine | Recruiting | Guangzhou | Guangdong | 510120 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form: Study Protocol | Jul 24, 2025 | Aug 5, 2025 | Prot_ICF_000.pdf |
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| ID | Term |
|---|---|
| D065632 | Chikungunya Fever |
| ID | Term |
|---|---|
| D018354 | Alphavirus Infections |
| D001102 | Arbovirus Infections |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
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Percentage of subjects achieving restoration of white blood cell, lymphocyte and platelet counts to normal reference ranges |
| From the enrollment to the end of the treatment on the 5th day. |
| Time to Symptom Recovery | Assesses the duration until complete resolution of all symptoms (e.g., fatigue, headache, myalgia). | From the enrollment to the end of the observation on the 28th day. |
| Incidence of Complications | Monitors the occurrence of complications (e.g., chronic arthritis, neurological involvement, secondary infections). | From the enrollment to the end of the observation on the 28th day. |
| Adverse Events (AEs) | Records all AEs (e.g., allergic reactions, gastrointestinal issues) and their relation to the treatment. | From the enrollment to the end of observation on the 28th day. |
| Proportion of participants with normalized C-reactive protein (CRP) levels | Percentage of subjects achieving serum CRP levels within normal reference range (≤5 mg/L) | From the enrollment to the end of the treatment on the 5th day. |
| Proportion of participants with restored baseline-abnormal coagulation parameters | Percentage of subjects achieving normalization in coagulation parameters that were abnormal at baseline (e.g., PT, aPTT, INR, D-Dimer) | From the enrollment to the end of the treatment on the 5th day. |
| D000096724 |
| Mosquito-Borne Diseases |
| D014777 | Virus Diseases |
| D014036 | Togaviridae Infections |
| D012327 | RNA Virus Infections |