Chikungunya FeverNCT07126171
A Clinical Study on the Efficacy and Safety of Reduning Injection in the Treatment of Chikungunya Fever
A study testing Reduning injection and The simulant of Reduning Injection in people with Chikungunya Fever, run by Jiangsu Kanion Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
To evaluate the efficacy and safety of Reduning Injection in the treatment of chikungunya fever Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chikungunya Fever
- What is being tested?
- Reduning injection and The simulant of Reduning Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 28 Aug 2025to 18 Feb 2026
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the diagnostic criteria for chikungunya fever (can be randomly selected based on suspected cases);
- Fever duration ≤ 48 hours, and at the time of consultation, axillary temperature ≥ 38.0℃ (if antipyretic drugs have been taken, the axillary temperature must be ≥ 38.0℃ 4 hours or later after taking the drugs);
- The first symptoms of chikungunya fever other than fever have a duration ≤ 72 hours;
- At the time of consultation, have one or more of the following symptoms: headache, back pain or generalized muscle pain, nausea and vomiting, joint pain, joint swelling, joint stiffness, rash, and the severity is moderate or above;
- Age between 18 and 70 years old (including both ends), gender not restricted;
- Provide informed consent and sign the informed consent form.
Who cannot join
- Those diagnosed with dengue fever, alphavirus infection, influenza, novel coronavirus infection, infectious erythema, post-infection arthritis (including rheumatic fever), scarlet fever, rickettsial diseases (typhus, scrub typhus), measles, drug-induced rash, etc.;
- Acute, chronic stages of chikungunya fever and high-risk populations;
- Those with severe primary diseases of the cardiovascular, liver, kidney and hematopoietic systems;
- Those with chronic arthritis;
- Those with immunodeficiency (such as AIDS patients, those with long-term use of corticosteroids or other immunosuppressive drugs resulting in weakened immune function);
- Those with obesity (BMI ≥ 30 kg/m2) or weight < 40 kg;
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- Those suspected or confirmed to have alcohol addiction, drug abuse history, or those with cognitive impairment, severe mental illness and unable to cooperate with the clinical study;
- Pregnant women or those preparing for pregnancy within 6 months, and lactating women;
- Those with allergic constitution, such as history of allergy to two or more drugs or foods, or those known to be allergic to the drugs used in this study and the ingredients of acetaminophen tablets;
- Those who participated in any clinical study within 3 months before the screening examination;
- Those judged by the researcher to be not suitable to participate in this clinical study.
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
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510080
Zhong nanshan The First Affiliated Hospital of Guangzhou Medical University, +86 13609003622, nanshan@vip.163.com
Academician of Chinese Academy of Engineering
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Clinical Study on the Efficacy and Safety of Reduning Injection in the Treatment of Chikungunya Fever
To evaluate the efficacy and safety of Reduning Injection in the treatment of chikungunya fever
Read the detailed description
This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical study of the efficacy and safety of Reduning Injection in the treatment of Chikungunya fever. The purpose of this study is to evaluate the efficacy and safety of Reduning Injection in the treatment of Chikungunya fever. The study uses the IWRS system to randomize the study participants, adopts the double-blind method, selects placebo control, plans to be conducted simultaneously in multiple research centers across the country, plans to include 400 study participants, and randomly assigns them to the test drug group and the placebo group at a 1:1 ratio, with 200 participants in the test drug group.
- Conditions
- Chikungunya Fever
- Being tested
- Reduning injection, The simulant of Reduning Injection
- Medical subject headings
- Chikungunya Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduning injectionDrug
reduning Injection, intravenous drip, 20 ml per time, once a day;
The simulant of Reduning InjectionDrug
The simulant of Reduning Injection, for intravenous drip, 20 ml per time, once a day
| Study group | Role | What they receive |
|---|---|---|
| Reduning treatment group | Experimental | Redunign Injection, intravenous drip, 20 ml per dose, once a day Receives: Drug: Reduning injection |
| placebo group | Placebo comparator | The simulant of Reduning Injection, for intravenous drip, 20 ml per time, once a day Receives: Drug: The simulant of Reduning Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of symptoms
The time from the first administration of the medication until all scores for the symptoms of chikungunya fever were 0 or 1 points (if the score was 1 before the medication, it must be reduced to 0), and this remained stable for 48 hours or more
Measured: -1 day to 0 day, medication duration of 5 days ± 1 day, onset of disease 14 days ± 2 days after the onset, 90 days ± 3 days after the onset
Secondary outcomes (8)
Recovery time of body temperature
The time required for the axillary temperature to be ≤ 37.0℃ after medication administration and to remain at this level for 24 hours or more
Measured: The subjects recorded these information in the "Subject Diary Card" during the period from -1 day to 0 day, 5 days ± 1 day after medication administration, and 14 days ± 2 days after the onset of the disease.
Time for fever reduction to take effect
The time required for the first drop of 0.5℃ or more in axillary temperature after medication administration
Measured: The subjects recorded these information in the "Subject Diary Card" during the period from -1 day to 0 day, 5 days ± 1 day after medication administration, and 14 days ± 2 days after the onset of the disease.
The change in the integer VAS score for joint pain from baseline after 5 days of medication and 14 days after the onset of the disease
The severity of joint pain was evaluated using the Visual Analogue Scale (VAS). This method employed a 100mm long straight line, where 0 represented no joint pain symptoms and 100 represented the most intense pain. The research participants marked the corresponding position on the line that indicated their most severe level of pain. This was recorded during visits 1 to 3 in the "Research Participant Diary Card". The recording points were as follows: The first time, record the most severe pain level within 0.5 hours before the first medication administration; thereafter, record the most severe pain level once at 08:00 and 20:00 each day, with a time window of ±1 hour; if the score is 0 for more than 48 hours, there is no need to record again.
Measured: After taking the medicine for 5 days, 14 days after the onset of the disease
The change in the number of joint pain episodes compared to the baseline value
Measured: The researchers conducted evaluations on the study participants once each at -1 day to 0 day, 5 days ± 1 day after medication administration, and 14 days ± 2 days after the onset of the disease.
Time for disappearance of individual symptoms
The symptom score after medication administration was 0, and the duration required for it to remain at this score for 24 hours or longer.
Measured: -1 day to 0 day, medication duration of 5 days ± 1 day, onset of disease 14 days ± 2 days after the onset, 90 days ± 3 days after the onset
The rate of disappearance of individual symptoms
The symptom score after medication administration was 0, and the duration required for it to remain at this score for 24 hours or longer.
Measured: -1 day to 0 day, medication duration of 5 days ± 1 day, onset of disease 14 days ± 2 days after the onset, 90 days ± 3 days after the onset
The incidence rate of complications (such as bleeding, hematoma, encephalitis, myelitis, etc.)
The incidence rate of complications (such as bleeding, hematoma, encephalitis, myelitis, etc.)
Measured: From -1 day to 0 day, and up to 90 days ± 3 days after the onset of the disease, the occurrence of complications by the subjects will be recorded by the researchers.
The usage situation of emergency medications
The subjects should record in the "Subject Diary Card" before each use of emergency medication.
Measured: From -1 day to 0 day, within 5 days ± 1 day after medication administration, and 14 days ± 2 days after the onset of the disease.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start28 Aug 2025 (estimated)
- Primary completion26 Nov 2025 (estimated)
- Study completion18 Feb 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Kanion Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07126171
- Sponsor's protocol ID
- KYZY-RDN-Ⅴ-CHIKF-202504
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Clinical Study on the Efficacy and Safety of Reduning Injection in the Treatment of Chikungunya Fever
- ClinicalTrials.gov ID
- NCT07126171
- Acronym / sponsor ID
- KYZY-RDN-Ⅴ-CHIKF-202504
- Conditions
- Chikungunya Fever
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Jiangsu Kanion Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2025 (estimated)
- Primary completion
- 26 Nov 2025 (estimated)
- Study completion
- 18 Feb 2026 (estimated)
- First posted
- 17 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.
To evaluate the efficacy and safety of Reduning Injection in the treatment of chikungunya fever
Detailed description
This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical study of the efficacy and safety of Reduning Injection in the treatment of Chikungunya fever. The purpose of this study is to evaluate the efficacy and safety of Reduning Injection in the treatment of Chikungunya fever. The study uses the IWRS system to randomize the study participants, adopts the double-blind method, selects placebo control, plans to be conducted simultaneously in multiple research centers across the country, plans to include 400 study participants, and randomly assigns them to the test drug group and the placebo group at a 1:1 ratio, with 200 participants in the test drug group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduning treatment group | Experimental | Drug: Reduning injectionRedunign Injection, intravenous drip, 20 ml per dose, once a day |
| placebo group | Placebo comparator | Drug: The simulant of Reduning InjectionThe simulant of Reduning Injection, for intravenous drip, 20 ml per time, once a day |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Meet the diagnostic criteria for chikungunya fever (can be randomly selected based on suspected cases);
- Fever duration ≤ 48 hours, and at the time of consultation, axillary temperature ≥ 38.0℃ (if antipyretic drugs have been taken, the axillary temperature must be ≥ 38.0℃ 4 hours or later after taking the drugs);
- The first symptoms of chikungunya fever other than fever have a duration ≤ 72 hours;
- At the time of consultation, have one or more of the following symptoms: headache, back pain or generalized muscle pain, nausea and vomiting, joint pain, joint swelling, joint stiffness, rash, and the severity is moderate or above;
- Age between 18 and 70 years old (including both ends), gender not restricted;
Key exclusion criteria (11 listed)
- Those diagnosed with dengue fever, alphavirus infection, influenza, novel coronavirus infection, infectious erythema, post-infection arthritis (including rheumatic fever), scarlet fever, rickettsial diseases (typhus, scrub typhus), measles, drug-induced rash, etc.;
- Acute, chronic stages of chikungunya fever and high-risk populations;
- Those with severe primary diseases of the cardiovascular, liver, kidney and hematopoietic systems;
- Those with chronic arthritis;
- Those with immunodeficiency (such as AIDS patients, those with long-term use of corticosteroids or other immunosuppressive drugs resulting in weakened immune function);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reduning injectionreduning Injection, intravenous drip, 20 ml per time, once a day; | Drug | Reduning treatment group |
| The simulant of Reduning InjectionThe simulant of Reduning Injection, for intravenous drip, 20 ml per time, once a day | Drug | placebo group |
Primary outcome
Duration of symptoms
Time frame: -1 day to 0 day, medication duration of 5 days ± 1 day, onset of disease 14 days ± 2 days after the onset, 90 days ± 3 days after the onset
The time from the first administration of the medication until all scores for the symptoms of chikungunya fever were 0 or 1 points (if the score was 1 before the medication, it must be reduced to 0), and this remained stable for 48 hours or more
8 secondary outcomes
Recovery time of body temperature
Time frame: The subjects recorded these information in the "Subject Diary Card" during the period from -1 day to 0 day, 5 days ± 1 day after medication administration, and 14 days ± 2 days after the onset of the disease.
Time for fever reduction to take effect
Time frame: The subjects recorded these information in the "Subject Diary Card" during the period from -1 day to 0 day, 5 days ± 1 day after medication administration, and 14 days ± 2 days after the onset of the disease.
The change in the integer VAS score for joint pain from baseline after 5 days of medication and 14 days after the onset of the disease
Time frame: After taking the medicine for 5 days, 14 days after the onset of the disease
The change in the number of joint pain episodes compared to the baseline value
Time frame: The researchers conducted evaluations on the study participants once each at -1 day to 0 day, 5 days ± 1 day after medication administration, and 14 days ± 2 days after the onset of the disease.
Time for disappearance of individual symptoms
Time frame: -1 day to 0 day, medication duration of 5 days ± 1 day, onset of disease 14 days ± 2 days after the onset, 90 days ± 3 days after the onset
The rate of disappearance of individual symptoms
Time frame: -1 day to 0 day, medication duration of 5 days ± 1 day, onset of disease 14 days ± 2 days after the onset, 90 days ± 3 days after the onset
The incidence rate of complications (such as bleeding, hematoma, encephalitis, myelitis, etc.)
Time frame: From -1 day to 0 day, and up to 90 days ± 3 days after the onset of the disease, the occurrence of complications by the subjects will be recorded by the researchers.
The usage situation of emergency medications
Time frame: From -1 day to 0 day, within 5 days ± 1 day after medication administration, and 14 days ± 2 days after the onset of the disease.
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 17 Aug 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduning injection and The simulant of Reduning Injection in people with Chikungunya Fever, run by Jiangsu Kanion Pharmaceutical Co., Ltd 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 6 inclusion and 11 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: opening soon, as of the sponsor's last update on 17 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. Some participants in this study may receive a placebo. 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?
Contact Zhao binjiang Director of Clinical Research (+86 15300025287, zbj0601@kanion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of symptoms (time frame: -1 day to 0 day, medication duration of 5 days ± 1 day, onset of disease 14 days ± 2 days after the onset, 90 days ± 3 days after the onset). 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 17 Aug 2025.