Efficacy and safety of fixed dose combination of drotaverine hydrochloride(80 mg)and paracetamol(500 mg) in amelioration of abdominal pain in acute infectious gastroenteritis: a double blind randomized controlled trial

Walter Bushnell Pvt Ltd0 个研究点目标入组 250 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Patients between 18 to 59 years of either gender with presenting with acute infectious diarrhoea (defined as at least 3 unformed, watery or soft, stools accompanied by symptoms within 24 hours preceding randomization with duration of illness <= 72 hours) who present with moderate to severe (baseline pain intensity [PI] score on a 100-mm visual analog scale [VAS] of > 50 mm and â??moderate to severeâ?? on a VRS scale) abdominal pain present at enrollment.
•2.Patients who give written informed consent with videography prior to the study entry.
•3.Patients with good health as determined by:
•Medical history
•Physical examination
•Clinical judgment of the investigator

•1.Patients with moderate or severe dehydration requiring hospitalization and administration of intravenous medications.
•2.Patients with bloody diarrhoea and dysentery.
•3.Any previous clinical history of gastroduodenal ulcer, gastrointestinal bleeding, or gastroduodenal perforation.
•4.Concomitant use of medications that are known to increase the likelihood of upper gastrointestinal adverse events (e.g. corticosteroids and anticoagulants).
•5.Patients with other established etiologies as pancreatitis, inflammatory bowel disease (IBD) or irritable bowel disease (IBS), previous gastrointestinal surgery and known immunodeficiency.
•6.Patients with history of hypersensitivity to paracetamol and/or drotaverine.
•7.Patients taking opioid analgesics, NSAIDs, and sedatives in the last 24 hours.
•8.Presence of serious co-morbidity, such as cardiovascular disease, cerebrovascular disease, renal or hepatic impairment, diabetes, hypertension, hypo or hyperthyroidism.
•9.Pregnant & lactating women.
•10.Patients participating in any other clinical trial.

发起方

Walter Bushnell Pvt Ltd