Chikungunya FeverNCT07120724
Real-World Study on Chinese Medicine for Treating Chikungunya Fever
An observational study of Chikungunya Fever, run by Guangzhou University of Traditional Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chikungunya Fever
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 26 Jul 2025to 26 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangdong Province Hospital of Tradtional Chinese Medicine
Guangzhou, Guangdong, 510120
jianwen Guo, Dr, 020-81887233 ext. 34530, jianwen_guo@msn.com
Jianwen Guo, MD
About this study
Official title: Efficacy and Safety of Chinese Medicine in the Treatment of Chikungunya Fever: A Real-World Observational Study
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
- Medical subject headings
- Chikungunya Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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.
Measured: From the enrollment to the end of the observation on the 28th day.
Secondary outcomes (7)
Time to Viral RNA Clearance (RT-PCR Negative)
Measures the days required for chikungunya virus RNA to become undetectable in blood by RT-PCR.
Measured: From the enrollment to the end of the treatment on the 5th day.
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
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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)
Measured: 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)
Measured: From the enrollment to the end of the treatment on the 5th day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start26 Jul 2025
- Primary completion26 Jul 2026 (estimated)
- Study completion26 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chikungunya FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120724
- Sponsor's protocol ID
- ZE2025-299-01
- Status last verified
- Aug 2025
- First submitted
- 25 Jul 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Chinese Medicine in the Treatment of Chikungunya Fever: A Real-World Observational Study
- ClinicalTrials.gov ID
- NCT07120724
- Acronym / sponsor ID
- ZE2025-299-01
- Conditions
- Chikungunya Fever
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 26 Jul 2025 (actual)
- Primary completion
- 26 Jul 2026 (estimated)
- Study completion
- 26 Dec 2026 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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
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.
7 secondary outcomes
Time to Viral RNA Clearance (RT-PCR Negative)
Time frame: From the enrollment to the end of the treatment on the 5th day.
Proportion of participants with normalized blood cell counts
Time frame: From the enrollment to the end of the treatment on the 5th day.
Time to Symptom Recovery
Time frame: From the enrollment to the end of the observation on the 28th day.
Incidence of Complications
Time frame: From the enrollment to the end of the observation on the 28th day.
Adverse Events (AEs)
Time frame: From the enrollment to the end of observation on the 28th day.
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.
Proportion of participants with restored baseline-abnormal coagulation parameters
Time frame: From the enrollment to the end of the treatment on the 5th day.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
Related trials for Chikungunya Fever
Active, not recruitingPhase 3
A Safety and Immunogenicity Study of CHIKV VLP Vaccine in Children.
Chikungunya Virus
Not yet recruitingPhase 2
Evaluation of IXCHIQ® Vaccine Immunogenicity
Healthy Adult, Healthy Adolescents
RecruitingPhase 4
Real-world Effectiveness, Safety & Immunogenicity of Chikungunya Vaccination: Ambispective Study in Reunion & French Guiana
Chikungunya Virus Infection
Recruiting
Against Chikungunya Virus and Neonatal Infection
Chikungunya Virus Infection, Neonatal
Enrolling by invitation
Smart Analysis and Decision-Making for Emerging Infectious Diseases
Emerging Infectious Diseases, COVID-19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guangdong Province Hospital of Tradtional Chinese Medicine
Guangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chikungunya Fever, run by Guangzhou University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.