An open-label clinical study to evaluate the efficacy and safety of DizesterÃ?Â® Herbal in Patients suffering from functional dyspepsia.

Dr Willmar Schwabe India Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•1.Patients in the age group between 18 to 65
•years of either sex.
•2.Patients able to provide informed consent.
•3.Subject fulfilling the Rome IV criteria for functional dyspepsia which
•includes one or more of the following
•Ã¢â?¬Â¢Bothersome postprandial fullness
•Ã¢â?¬Â¢Bothersome early satiation
•Ã¢â?¬Â¢Bothersome epigastric pain
•Ã¢â?¬Â¢Bothersome epigastric burning and
•Ã¢â?¬Â¢No evidence of structural diseases (including the upper endoscopy) that
•is likely to explain the symptoms
•Ã¢â?¬Â¢Must fulfill criteria for Postprandial Distress Syndrome and or
•Epigastric Pain Syndrome.
•Ã¢â?¬Â¢Criteria fulfilled for the last 3 months with symptom onset at least 6
•months before diagnosis.
•4.Patients will included on the basis of signs and symptoms of Non ulcer dyspepsia, epigastric pain, burning sensation over epigastrium/ retrosternal region, sour, bitter eructation, nausea, vomiting, indigestion and abdominal distension.

•1.Patients on Proton pump inhibitors
•2.Pregnant or lactating women or with infants less than 1 year
•3.Any preexisting condition or contraindications like CAD, abnormal creatinine levels, liver
•dysfunction.
•4.Patients with alarm features like unintentional weight loss, recurrent vomiting, dysphagia,
•hemetemesis, melena, fever, jaundice, or anemia
•5.Any kind of organic lesion such as peptic ulcer, tumor of any kind, stricture, or structural
•6.A previous endoscopic diagnosis of erosive gastroesophagitis or Barretts esophagus
•7.Subject with known history of gastric bleeding, intestinal obstruction or perforation, and
•previous gastrointestinal surgery.
•8.Subjects with major systemic illness including cardiac disease, liver disease, kidney
•disease, diabetes, hypertension, psychoneuroendocrinal disorders
•9.Smoking or drug addicts or with psychiatric illness.

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