Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Clinical Trial of the Efficacy and Safety of Rengalin in the Treatment of Cough in Acute Viral Upper Respiratory Tract Infections Tract Infections in Children During the Epidemic Growth of Influenza and ARVI
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 264
- 试验地点
- 30
- 主要终点
- The percentage of patients responded to treatment
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy and safety of liquid dosage form of Rengalin in the treatment of cough in acute viral upper respiratory tract infections infections in children in during the epidemic growth of influenza and ARVI. The main questions it aims to answer are:
Investigators will compare the liquid dosage form of Rengalin to a placebo (a look-alike substance that contains no drug) to see if Rengalin in the liquid dosage form works for cough in acute viral upper respiratory tract infections in children.
Participants will:
Take the liquid dosage form of Rengalin or placebo per os 5 ml per administration 3 times a day for 7 days.
详细描述
The design is a multicenter, double-blind, placebo-controlled, randomized, parallel-group clinical trial evaluating the efficacy and safety of the study therapy.
The trial will enroll children of either gender aged 6 months to 3 years, who consulted a physician for dry/non-productive cough caused by acute viral upper respiratory tract infections during the seasonal growth of influenza and ARVI.
The duration of cough at inclusion in the trial should be at least 24 hours but not more than 72 hours; cough severity - 6 or more points (according to the Cough Severity Score (CSS)).
After one of the parents/adoptive parents signs the patient information leaflet (PIL) and the informed consent form (ICF) (two versions are used - with the consent of the parent/adoptive parent to take blood and urine samples for the purpose of conducting laboratory tests or without consent) for participation in the clinical trial at Visit 1, complaints and anamnesis are collected, vital signs are assessed, a physical examination is performed, concomitant therapy is recorded, and laboratory tests are conducted.
It is planned to conduct a general urine analysis, general and biochemical blood tests in at least 50% of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients of both genders aged over 6 months and under 3 years.
- •Clinically confirmed diagnosis of acute viral upper respiratory tract infections (acute pharyngitis, nasopharyngitis, tonsillitis, laryngitis, laryngotracheitis, tracheitis, acute viral respiratory infection of multiple and unspecified localization) during the epidemic growth of influenza and ARVI.
- •Dry (non-productive) cough lasting at least 24 hours but not more than 72 hours.
- •Total (day and night) cough severity score of 6 or more.
- •Availability of a patient information sheet and an informed consent form for participation in the clinical trial signed by one of the patient's parents/adoptive parents.
排除标准
- •Presence of the following diseases at the time of inclusion in the clinical trial:
- •1.1 Inflammatory processes in the lower respiratory tract. 1.2 Grade III adenoid hypertrophy. 1.3 Chronic adenoiditis. 1.4 Postnasal drip syndrome. 1.5 Gastroesophageal reflux. 1.6 Bronchial asthma. 1.7 Cystic fibrosis. 1.8 Primary ciliary dyskinesia 1.9 Bronchopulmonary dysplasia 1.10 Malformations of the respiratory and ENT organs 1.11 Other chronic lung diseases. 1.12 Primary/secondary immunodeficiency. 1.13 Oncological disease of any localization.
- •Suspected bacterial infection of any localization, including pneumonia, sinusitis, otitis media.
- •Allergic rhinitis.
- •Bronchial obstruction syndrome.
- •Acute obstructive laryngitis [croup] and epiglottitis.
- •Congenital heart defects with hypervolemia in pulmonary circulation.
- •Acute respiratory failure.
- •Inflammatory, degenerative, demyelinating diseases of the central nervous system, polyneuropathies, epilepsy.
- •Exacerbation or decompensation of chronic diseases affecting the patient's ability to participate in a clinical trial.
- •Presence of allergy/hypersensitivity to any components of the medicines used in the treatment.
- •Taking medications listed in the section "Prohibited Concomitant Therapy" within 4 weeks prior to inclusion in the study.
- •Patients whose parents/adoptive parents, from the investigator's point of view, will not comply with observation requirements during the study or with the administration of study drugs.
- •Participation in other clinical trials within 3 months prior to inclusion in this trial.
- •A patient's parent/adoptive parent is related to on-site research personnel directly involved in the trial, or is the immediate family member of the investigator. 'Immediate family members' mean spouses, parents, children, or siblings, whether related or adopted.
- •The patient's parent/adoptive parent is employed by OOO "NPF "MATERIA MEDICA HOLDING", i.e., is an employee of the company, a temporary contract employee, or a designated official responsible for conducting the trial or their immediate family member.
研究组 & 干预措施
Rengalin
Orally. 5 ml per dose 3 times a day for 7 days. The drug is taken without meals.
干预措施: Rengalin (Drug)
Placebo
Placebo using the dosing regimen Rengalin for 7 days.
干预措施: Placebo (Drug)
结局指标
主要结局
The percentage of patients responded to treatment
时间窗: On baseline and 3 day
The percentage of patients responded to treatment (reduction in the total (day and night) cough severity score to 3 points or less after 3 days of treatment - isolated cough episodes or complete absence of cough during the day) after 3 days.
次要结局
- Change in the total CSS(On baseline and 7 day)