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A randomized, double-blind, placebo-controlled, multicenter clinical study on the efficacy and safety of Re Tu Ning Injection in the treatment of chikungunya fever

A randomized, double-blind, placebo-controlled, multicenter clinical study on the efficacy and safety of Re Tu Ning Injection in the treatment of chikungunya fever

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001541
Enrollment
Unknown
Registered
2025-08-08
Start date
2025-08-26
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chikungunya fever

Interventions

placebo group:reduningxin Ning Injection Simulant, intravenous drip, 20 ml per dose, once a day
treatment group:reduningxin Ning Injection , intravenous drip, 20 ml per dose, once a day

Sponsors

The First Affiliated Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Meets the diagnostic criteria for confirmed cases of Chikungunya fever (can be randomly selected based on suspected cases); (2) Fever duration = 48 hours, and body temperature = 38.0? at the time of consultation (if antipyretic drugs have been taken, the body temperature must be = 38.0? 4 hours or later after taking the drugs); (3) The first symptom of Chikungunya fever other than fever has a duration of = 72 hours; (4) At the time of consultation, possess 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; (5) Age between 18 and 70 years old (including both ends), gender not limited; (6) Has given informed consent and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1) 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 rash, etc.; (2) Acute, chronic stages of chikungunya fever and high-risk populations; (3) Those with severe primary diseases in the cardiovascular, liver, kidney and hematopoietic systems; (4) Those with chronic arthritis diseases; (5) Those with immunodeficiency (such as AIDS patients, those with long-term use of corticosteroids or other immunosuppressive drugs resulting in weakened immune function); (6) Those with obesity (BMI = 30 kg/m2) or weight < 40 kg; (7) 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 completion of clinical research; (8) Pregnant women or those preparing for pregnancy within 6 months, lactating women; (9) Those with allergic constitution, such as history of allergy to two or more drugs or foods, or known to be allergic to the drugs used in this study and the ingredients contained in acetaminophen tablets; (10) Those who participated in any clinical research within 3 months before the screening examination; (11) Those judged by the researchers to be not suitable to participate in this clinical study.

Design outcomes

Primary

MeasureTime frame
Duration of symptoms;

Secondary

MeasureTime frame
Recovery time of body temperature to normal;Time for fever reduction to take effect;The change in integer VAS scores for joint pain compared to the baseline;The change in the number of joint pain episodes compared to the baseline value;Time for disappearance of individual symptoms;Complication occurrence rate;The usage of emergency medications;The rate of disappearance of individual symptoms;

Countries

China

Contacts

Public ContactZhong nanshan

The First Affiliated Hospital of Guangzhou Medical University

nanshan@vip.163.com13609003622

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026