Clinical Evaluation of Narikela Lavana and Amalakyadi Churna in the management of Amlapitta (Functional Dyspepsia).

CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年3月4日

试验速览

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•1.Patients of either sex aged between 18 to 50 years.
•2.Subject fulfilling Rome IV criteria (2016) for Functional Dyspepsia.
•3.Criteria fulfilled for the last 3 months with symptom onsetat least 6 months prior to diagnosis with one or more of the followingsymptoms:upper abdominal (epigastric) pain/discomfort, postprandial fullness, early satiation, bloating, nausea and belching.
•4.No evidence of any organic disease.
•5.Subject should be able to provide a written informed consent

•1.Positive Helicobacter pylori test.
•2.Any organic lesions such as peptic ulcer, tumor of any kind, stricture or structural deformity.
•3.Subject with known history of gastric bleeding, intestinal obstruction or perforation and previous gastrointestinal surgery.
•4.Subjects with major systemic illness including cardiac disease, liver disease, kidney disease, diabetes, hypertension, inflammatory bowel disease, psycho-neuro-endocrinal disorders.)
•5.Patients on prolonged (=6 weeks) medication with corticosteroids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study.
•6.Subject currently taking drugs that may affect gastrointestinal motility (e.g., anticholinergic, Reglan, erythromycin, azithromycin, Domperidone, etc.), Buspirone, Acotiamide, Tramadol, nonsteroidal anti-inflammatory drug,
•7.History of hypersensitivity to any of the trial drugs or their ingredients.
•8.Pregnant or lactating women
•9.Patients who are judged by the investigators to be unsuitable to participate in the clinical trial (diagnosed psychotic illnesses, substance dependence or alcoholism)

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