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

Not Applicable

Not yet recruiting

• Conditions: Chikungunya Fever
• Interventions: Drug: Reduning injection; Drug: The simulant of Reduning Injection

• Registration Number: NCT07126171
• Lead Sponsor: Jiangsu Kanion Pharmaceutical Co., Ltd

Brief Summary

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 Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-04
• Study First Submitted QC: 2025-08-10
• Last Update Submitted: 2025-08-10
• Study First Posted: 2025-08-17
• Last Update Posted: 2025-08-17
• Study Start: 2025-08-28
• Primary Completion: 2025-11-26
• Study Completion: 2026-02-18

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reduning treatment group	Reduning injection	Redunign Injection, intravenous drip, 20 ml per dose, once a day
placebo group	The simulant of Reduning Injection	The simulant of Reduning Injection, for intravenous drip, 20 ml per time, once a day

Primary Outcome Measures

Name	Time	Method
Duration of 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	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

Secondary Outcome Measures

Name	Time	Method
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 time required for the first drop of 0.5℃ or more in axillary temperature after medication administration
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.
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.	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
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	The symptom score after medication administration was 0, and the duration required for it to remain at this score for 24 hours or longer.
The rate of 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	The symptom score after medication administration was 0, and the duration required for it to remain at this score for 24 hours or longer.
The incidence rate of complications (such as bleeding, hematoma, encephalitis, myelitis, etc.)	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 incidence rate of complications (such as bleeding, hematoma, encephalitis, myelitis, etc.)
The usage situation of emergency medications	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.	The subjects should record in the "Subject Diary Card" before each use of emergency medication.
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 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.

Trial Locations

Locations (1)

The First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China