Safety and Efficacy of Reconyl for Cough With/Without Sore Throat: A Preliminary Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Cough score
研究概览
简要总结
This study is a prospective, randomized, double-blind and placebo-controlled study to find out if reconyl may relieve the acute cough with/without sore throat.
详细描述
Reconyl is a mixed extract from 4 Indonesian herbs, Vitex trifolia (Legundi), Zingiber officinale var. Amarum (Jahe Gajah), Abrus precatorius (Saga), and Phaleria macrocarpa (Mahkota Dewa), which have been known traditionally to relieve cough, respiratory congestion, and sore throat.
There will be two parallel groups of 30 subjects per group (a total of 60 subjects) planned to be enrolled in this study.
The investigational product: tablets @ 225 mg of Reconyl. Dose administration: One tablet of Reconyl or Placebo, given 3 times daily, for 3 days.
Eligible subjects will be instructed to perform a daily self-assessment on the cough symptoms over the 3 days of treatment, in the Subject Diary. Subject shall return to the study clinic 3 days ± 24 hours after the first dose, for completion of the subject's participation in the 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy men or women aged 18 to 60 years with cough with/without sore throat with a maximum onset of 3 days.
- •Signing the informed consent.
排除标准
- •Body temperature of > 37.3˚C and/or refuse to follow health protocol for COVID-19
- •Known hypersensitivity to herbal drugs
- •Pregnant or lactating women
- •Have received any anti-inflammatory or cough-alleviating drugs within the past 24 hours
- •Presence of vomiting or diarrhea within the past 24 hours and still ongoing at the start of study
- •Severe illness, e.g. severe hypertension, any other chronic infections or diseases that may induce cough, such as: pulmonary tuberculosis, gastrointestinal reflux diseases (GERD)
研究组 & 干预措施
Treatment Group
1 tablet of Reconyl, 3 times daily
干预措施: Reconyl (Drug)
Control Group
1 tablet of placebo Reconyl, 3 times daily
干预措施: Placebo tablet of Reconyl (Drug)
结局指标
主要结局
Cough score
时间窗: Day 0, Day 1, Day 2, Day 3
Scoring will be performed and recorded daily in the Subject Diary at time 0, every night time and before the morning dose. At the End of Study (last visit) will be assessed by the subject and recorded by the Investigator. Cough score: • Day time: 0 = No cough; 1= Transient cough occasionally during the daytime; 2 = Frequent cough mildly affecting daily life; 3 = Frequent cough severely affecting daily life. • Night time: 0 = No cough; 1= Transient cough before sleep or occasional cough during the night; 2 = Cough mildly affecting night sleep; 3 = Cough severely affecting night sleep.
Visual Analogue Scale (VAS)
时间窗: Day 0, Day 1, Day 2, Day 3
Visual Analogue Scale (VAS) for sore throat (0 - 100), with 0 indicates asymptomatic and 100 refers to the most serious or severe symptom. VAS will be assessed and recorded daily in Subject Diary at time 0, every night time and before the morning dose. At the End of Study (last visit) will be assessed by the subject and recorded by the Investigator.
Adverse events
时间窗: Day 0, Day 1, Day 2, Day 3
Any adverse events (AE) and serious adverse events (SAE) will be observed throughout the study conduct.
次要结局
未报告次要终点