To evaluate the efficacy and safety of Reduning Injection in the treatment of chikungunya fever
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
400
reduning Injection, intravenous drip, 20 ml per time, once a day;
The simulant of Reduning Injection, for intravenous drip, 20 ml per time, once a day
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
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
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
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
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
The time required for the first drop of 0.5℃ or more in axillary temperature after medication administration
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
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.
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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
The symptom score after medication administration was 0, and the duration required for it to remain at this score for 24 hours or longer.
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
The symptom score after medication administration was 0, and the duration required for it to remain at this score for 24 hours or longer.
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.)
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
The subjects should record in the "Subject Diary Card" before each use of emergency medication.
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.