A Prospective, Open-label, Non-comparative, Multi-centric Active PMS to evaluateefficacy and safety of STOMAFIT ORAL LIQUID containing Liquor Bismuth Ammonium Citrate2.5ml, Belladonna Dry Extract 9mg, Thymol 0.15mg and Menthol 0.2 mg in Gastritis orGastroesophageal Reflux Disease (GERD)
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Relief in signs and / or symptoms of patients’ disease. Each symptom or patient complaint will be given intensity score, to describe its intensity from mild to severe, on the Numeric Rating Scale of 01 to 10 starting mildest intensity from 01. Following is an indicative Numerical Rating Scale for measurement of pain intensity
研究概览
简要总结
A Prospective, Open-label, Non-comparative, Multi-centric Active PMS toevaluate efficacy and safety of STOMAFIT ORAL LIQUID containing Liquor BismuthAmmonium Citrate 2.5ml, Belladonna Dry Extract 9mg, Thymol 0.15mg and Menthol0.2 mg in Gastritis or Gastroesophageal Reflux Disease (GERD)
Stomafit oral liquid is being marketed in India since more than a decadeby sponsor of the trial. The office of DCGI has asked to prove the safety andefficacy of the given FDC by conducting Active PMS.
Primary objective is to provide the preliminary evidence of safety ofSTOMAFIT ORAL LIQUID in the treatment of Gastritis or Gastroesophageal refluxdisease (GERD).
Secondary objective is to provide preliminaryevidence of efficacy of STOMAFIT ORAL LIQUID in the treatment of Gastritis orGastroesophageal reflux disease (GERD).
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female subjects 18-60 years of age
- •Patients having gastrointestinal illness; signs and symptoms confirmed from clinical judgement
- •Patients willing to give informed consent for the Active PMS and willing to comply with all the study procedure and requiremnets.
排除标准
- •History of HIV positive patients
- •Chronic heart failure, respiratory failure or chronic liver and renal failure.
- •Patient with active cancer.
- •Female who is pregnant, planning a pregnancy (during the course of the study) or nursing a child
- •Certain medications that may interfere with the study medication (these will be identified by the study Investigator).
结局指标
主要结局
Relief in signs and / or symptoms of patients’ disease. Each symptom or patient complaint will be given intensity score, to describe its intensity from mild to severe, on the Numeric Rating Scale of 01 to 10 starting mildest intensity from 01. Following is an indicative Numerical Rating Scale for measurement of pain intensity
时间窗: 1-3 weeks
次要结局
- Evaluate Efficacy of STOMAFIT(1-3 weeks)