About this trial
To evaluate the efficacy and safety of Reduning Injection in the treatment of chikungunya fever
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
Reduning injection
Drugreduning Injection, intravenous drip, 20 ml per time, once a day;
The simulant of Reduning Injection
DrugThe simulant of Reduning Injection, for intravenous drip, 20 ml per time, once a day
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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 for fever reduction to take effect
The time required for the first drop of 0.5℃ or more in axillary temperature after medication administration
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.
The change in the number of joint pain episodes compared to the baseline value
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: