Clinical study to study the safety and effect of a herbal formulation DRDC/2022/040 on symptoms of gastro oesophageal reflux disease â?? An open label, non-comparative, interventional, prospective study - NI

Dabur India Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年8月21日

试验速览

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•1.Subjects of either sex in the age group of 18 to 60 years, both inclusive.
•2.Subjects having average moderate reflux score (items 2 and 3) of Gastrointestinal symptoms rating scale (GSRS) [Appendix 2]
•3.Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.

•1.Known cases of diseases like gastric ulcer, duodenal ulcer, Gastric Ca etc.
•2.Subjects who undergone abdominal surgeries.
•3.Subjects with an anticipated need for concomitant medication with anticholinergics, promotility agents, prostaglandin analogs, sucralfate, nonsteroidal anti-inflammatory drugs (NSAIDs), or salicylates
•4.Chronic alcoholics and Habitual Tobacco chewers.
•5.Known cases of Severe/Chronic hepatic or renal disease.
•6. Known subject of any active malignancy.
•7.Subjects giving history of significant cardiovascular event < 12 weeks prior to recruitment.
•8.Subjects having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
•9. Known subjects of having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.
•10.Subjects using any other investigational drug within 1 month prior to recruitment or Subjects currently participating in any other Clinical study
•11.Known hypersensitivity to any of the ingredients used in study drug
•12.Pregnant and Lactating females.
•13.Any other condition due to which patients are deemed to be unsuitable by the investigator for reason(s) not specifically started in the exclusion criteria

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