A prospective open label study to evaluate the efficacy and safety of SoEazy in the management of constipation in adults.

Sami Labs Limited0 个研究点目标入组 24 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1 Patients suffering from constipation.
•2 Constipation as defined by the American College of Gastroenterology : Unsatisfactory defecation characterized by infrequent stools, difficult stool passage, or both.
•3 Difficult stool passage includes straining, a sense of difficulty passing stool, incomplete evacuation, hard/lumpy stools, prolonged time to stool.
•4 Men and non-pregnant women 18 to 60 years of age.
•5 Willing to give written informed consent.
•6 Patient who is able and willing to complete questionnaire.
•7 Having stool form between 1 to 3 on the Bristol Stool Form Scale.

•1 Patients with known or suspected history of hypersensitivity to the Investigational Product.
•2 Patients with known history of colorectal cancer, anal abscess, anal fistula, anal fissure, rectocele, inflammatory bowel diseases, or gastro intestinal obstruction.
•3 Patients with a known history of diabetes, hypertension, hypothyroidism, or any other metabolic disorders.
•4 Patients with unknown cause of gastro intestinal bleeding, or acute infection.
•5 Patients with symptoms of appendicitis or recent intestinal surgery.
•6 Patients whose chronic constipation, according to the Investigator clinical judgement, is thought to be a result of bowel surgery, gynaecological surgery, neurologic disorders, systemic sclerosis, myloidosis, scleroderma, myotonic dystrophy.
•7 Pregnant or lactating women.

发起方

Sami Labs Limited