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

Официальное название

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Clinical Study on the Efficacy and Safety of Reduning Injection in the Treatment of Chikungunya Fever

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат Reduning injection
  reduning Injection, intravenous drip, 20 ml per time, once a day;
• Препарат The simulant of Reduning Injection
  The simulant of Reduning Injection, for intravenous drip, 20 ml per time, once a day

Первичные конечные точки

• Duration of symptoms [Срок оценки: -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]

Вторичные конечные точки (8)

• Recovery time of body temperature [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: -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 [Срок оценки: -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.) [Срок оценки: 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 [Срок оценки: 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.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Guangzhou Medical University — Гуанчжоу

Идентификаторы

NCT: NCT07126171 · KYZY-RDN-Ⅴ-CHIKF-202504

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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