A Prospective, Multicentric Study, To Evaluate The Effectiveness And Safety Of Milk Of Magnesia+Liquid Paraffin+Sodium Picosulfate In The Treatment Of Constipation Symptoms In Post Ano-Rectal Surgical Patients - NA

Abbott India Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

试验速览

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•1.Post-ano-rectal surgery (anal fissures, anal fistulas, and hemorrhoids) patients of either sex, in the age group of =18 and =65 years.
•2.Patients having symptoms of constipation for a minimum of 3 days before the day of surgery.
•3.Women of childbearing potential who had a negative pregnancy test were non-lactating and were willing to use adequate throughout the study.
•4.Patients willing to comply with study procedures and requirements.
•5.Patients who understood the requirements of the study and were willing to sign and date the informed consent form before participating in the study.

•1.Patients with a history/ongoing congestive heart failure, severe hepatic or renal dysfunction, or neurological conditions (like Parkinson’s disease, multiple sclerosis, sacral nerve damage, and paraplegia or autonomic neuropathy).
•2.Pregnant or lactating women.
•3.Patients with ingestion of laxatives or any drug affecting GI motility in the last 3 days or known hypersensitivity, as per the discretion of the investigator at screening.
•4.Patients not willing to provide written informed consent to be excluded.
•5.Patients with ongoing intestinal obstruction, ileus, toxic megacolon gastric retention abdominal pain, nausea or vomiting, ongoing irritable bowel syndrome (IBS) with constipation at screening.
•6.Patients with history/ongoing psychiatric conditions.
•7.Patients with active or cured malignancies.
•8.Patients with a history of hypersensitivity to liquid paraffin, magnesium hydroxide, or sodium picosulfate.
•9.Patients with any medical condition judged by investigators that warrant exclusion at screening.
•10.Patients who have been on any laxatives containing, Milk of Magnesia, Liquid paraffin, and Sodium Picosulfate in the last 2 weeks.

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