CTRI/2020/03/023788已完成Unknown
Multi-centric, Open label, Single arm, Clinical Study to Evaluate the Efficacy and Safety of Kafnorm® Syrup for Symptomatic Relief of Dry or Productive Cough.
Virgo UAP Pharma Pvt2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年9月3日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Changes in day and night frequencies of cough: [Time
研究概览
简要总结
Multi-centric, Open-label, Single-arm, Clinical Study to Evaluate the Efficacy and Safety of Kafnorm® Syrup for Symptomatic Relief of Dry or Productive Cough.
Primary Objectives: To evaluate the clinical efficacy of Kafnorm® syrup for symptomatic relief of dry or productive cough.
Secondary Objectives: To assess the safety and tolerability of Kafnorm® syrup for symptomatic relief of dry or productive cough.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18−50 completed years.
- •History of acute dry or productive cough ≤ 1-week duration.
- •Cough score of 0,1,2 as per day time cough scale.
- •Willing to give written informed consent.
- •Able to comply with study requirements.
- •Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study.
- •Patient willing to refrain from smoking, alcohol, etc.
排除标准
- •Age < 18 years.
- •Pregnant (as per urine pregnancy test) or lactating female patient.
- •Past history of drug abuse and alcohol consumption since last 6 months.
- •Symptoms of the cough for more than 1 week.
- •Known immune deficiency.
- •Lung disease (include asthma or COPD).
- •Other respiratory disorders like Tuberculosis, chronic bronchitis, asthma, suspected pneumonia, suspected bacterial infections etc.
- •History / current condition of Cardiac disease like cardiomegaly, myocardial infraction, mitral regurgitation etc.
- •Gastrointestinal symptoms such as nausea, vomiting, abdominal pain or diarrhea.
- •History of uncontrolled Diabetes Mellitus.
- •Current smoker, Smoking history >10 packs per month.
- •Patient who received other medications and antibiotic (give all details) for cough within 3 days prior to Investigation drug administration.
- •History of or patients taking any medication that causes cough.
- •History of homemade therapy and patient not willing to refrain from such medications, therapy, home-made therapy during the treatment phase.
- •Patient agreed to avoid such condition like certain foods like cold foods, cold drinks, cough induced lifestyle and cold environmental conditions.
结局指标
主要结局
Changes in day and night frequencies of cough: [Time
时间窗: 5 days
frame: Baseline/Screening & 1, 2 & 3 days post-treatment]
时间窗: 5 days
– Will be evaluated on 6 point scale in treated patient. 1. Change in throat irritation: [Time frame:
时间窗: 5 days
be evaluated on 6 point scale.
时间窗: 5 days
Baseline/Screening & 1, 2 & 3 days post-treatment] – Will
时间窗: 5 days
次要结局
- 1. Duration of relief from symptoms(2. Time to relief from cough and throat irritation)
研究者
研究点 (2)
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