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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorJiangsu Kanion Pharmaceutical Co., Ltd

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Reduning injection

    Drug

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

  • The simulant of Reduning Injection

    Drug

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

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Reduning treatment groupExperimental treatment 1 intervention
Group B: placebo groupPlacebo comparator 1 intervention

Trial outcomes

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

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

Secondary outcomes

1

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.
2

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.
3

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.

Time frame
After taking the medicine for 5 days, 14 days after the onset of the disease
4

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.

Other outcomes

Sponsors and contacts

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