A Clinical Study on the Efficacy and Safety of Reduning Injection in the Treatment of Chikungunya Fever

Jiangsu Kanion Pharmaceutical

Status: Not yet enrolling

Conditions: Chikungunya Fever

Treatments: Drug: The simulant of Reduning Injection; Drug: Reduning injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07126171

KYZY-RDN-Ⅴ-CHIKF-202504

Details and patient eligibility

About

To evaluate the efficacy and safety of Reduning Injection in the treatment of chikungunya fever

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Meet the diagnostic criteria for chikungunya fever (can be randomly selected based on suspected cases);
2. 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);
3. The first symptoms of chikungunya fever other than fever have a duration ≤ 72 hours;
4. 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;
5. Age between 18 and 70 years old (including both ends), gender not restricted;
6. Provide informed consent and sign the informed consent form.

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-induced rash, etc.;
2. Acute, chronic stages of chikungunya fever and high-risk populations;
3. Those with severe primary diseases of the cardiovascular, liver, kidney and hematopoietic systems;
4. Those with chronic arthritis;
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 clinical study;
8. Pregnant women or those preparing for pregnancy within 6 months, and lactating women;
9. 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;
10. Those who participated in any clinical study within 3 months before the screening examination;
11. Those judged by the researcher to be not suitable to participate in this clinical study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 2 patient groups, including a placebo group

Reduning treatment group

Experimental group

Description:

Redunign Injection, intravenous drip, 20 ml per dose, once a day

Treatment:

Drug: Reduning injection

placebo group

Placebo Comparator group

Description:

The simulant of Reduning Injection, for intravenous drip, 20 ml per time, once a day

Treatment:

Drug: The simulant of Reduning Injection