CTRI/2024/07/070750
Recruiting
Phase 4
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
ConditionsHealth Condition 1: K590- Constipation
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: K590- Constipation
- Sponsor
- Abbott India Limited
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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