A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate The Efficacy and Safety of Reconyl in Acute Cough Treatment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Changes of VAS Score on Cough
研究概览
简要总结
This is a 2-arm, prospective, randomized, double-blind, parallel, controlled, non-inferiority study comparing Reconyl at a dose of 225 mg three times daily and Reconyl Placebo three times daily for a 7-day course of therapy.
Reconyl is a combination of four Indonesian herbals, Vitex trifolia folium, Zingiber officinale rhizome, Abrus precatorius folium, and Phaleria macrocarpa fructus, which have been traditionally used in treating cough and common cold. A combination of these herbals is expected to relieve cough and soothe throat, provide a promising cough treatment which has no side effects.
详细描述
There will be 2 groups of treatment; each group will consist of 72 subjects with the treatment regimens for 7 days:
Treatment I : 1 tablet of Reconyl 225 mg three times daily; Treatment II : 1 tablet of Reconyl Placebo three times daily.
Subjects will be asked to come to the clinic at Baseline and at Visit 1 (Day 7) for evaluation of treatment efficacy. During the 7-day study period, subjects should record product consumption, any adverse events, and their daily VAS score in the provided Patient's Diary.
The safety profile of study medication other than vital signs and adverse event will be measured at Baseline and End of Study.
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
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent from the subject or the subject's legally acceptable representatives (must obtained before any trial related activities)
- •Male or female subjects, aged 18-50 years at screening
- •Experience acute cough, defined as sudden onset dominant or main symptom of acute or worsened cough, with or without sputum, in the span of 72 hours, avoiding prescription and non-prescription cough-relieving medications (e.g. antitusives such as codeine-based cough supressants or dextromethorphan HBr, and mucolytics such as N-acetylsistein, Bromhexin and Ambroxol), within 24 hours before entering the study.
- •The condition of the patient does not have any illness other than acute cough that could possibly interfere with the study evaluation, such as chronic obstructive pulmonary disease (COPD), suspect GERD, rhinitis, asthma, tuberculosis (TB), and pneumonia.
- •Cooperative and able to fill out study material
排除标准
- •Subject with febrile within 24 hours before screening, or has body temperature ≥ 38°C during screening visit
- •Personal/family history of allergy or hypersensitivity or contradiction to any component of the drugs
- •History or clinical evidence of immunosuppression according to investigator assessment, or currently under treatment with immunosuppressive agents
- •Participation in any other trial less than 90 days before
- •Pregnancy or lactation
- •History of drug or alcohol abuse within 12 months prior to screening
研究组 & 干预措施
Reconyl
1 tablet of Reconyl 225 mg three times daily
干预措施: Reconyl (Drug)
Placebo of Reconyl
1 tablet of Reconyl Placebo three times daily
干预措施: Placebo of Reconyl (Drug)
结局指标
主要结局
Changes of VAS Score on Cough
时间窗: 7 days
Changes of VAS Score on Cough from Baseline to Day 7 of study treatment.
次要结局
- Changes of LCQ-acute score on Cough(7 days)
- Renal function (Serum creatinine and eGFR)(7 days)
- Liver function (ALT and AST)(7 days)
- Adverse events(7 days)