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

NCT07126171 | Not Yet Recruiting

• 1 other identifier: KYZY-RDN-Ⅴ-CHIKF-202504
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chikungunya Fever

Outcome Measures

Primary Outcomes (1)

• 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

  -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 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 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

  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

  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

  -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

Study Arms (2)

Reduning treatment group

EXPERIMENTAL

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

Drug: Reduning injection

placebo group

PLACEBO COMPARATOR

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

Drug: The simulant of Reduning Injection

Interventions

Reduning injection DRUG

reduning Injection, intravenous drip, 20 ml per time, once a day;

Reduning treatment group

The simulant of Reduning Injection DRUG

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

placebo group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Jiangsu Kanion Pharmaceutical Co., Ltd: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Chikungunya Fever

Interventions

reduning

Condition Hierarchy (Ancestors)

Alphavirus Infections; Arbovirus Infections; Vector Borne Diseases; Infections; Mosquito-Borne Diseases; Virus Diseases; Togaviridae Infections; RNA Virus Infections

Central Study Contacts

Zhao binjiang Director of Clinical Research

CONTACT

+86 15300025287; zbj0601@kanion.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 17, 2025
• Study Start: August 28, 2025
• Primary Completion: November 26, 2025
• Study Completion: February 18, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

CN (1)