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
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- 1. To determine the effectiveness of fixed-dose formulation of milk of magnesia, liquid paraffin, and sodium picosulphate oral emulsion in the treatment of constipation symptoms in post-ano-rectal surgical patients.
研究概览
简要总结
This is a prospective, multicenter, single-arm, open-label, post-marketing observational study designed to evaluate the effectiveness and safety of fixed-dose oral formulation containing the milk of magnesia, liquid paraffin, and sodium picosulphate (Cremaffin-Plus®, Abbott India Limited) oral emulsion in the management of constipation in Indian patients, post-ano-rectal surgery.
This multicenter study will enroll 80 patients, with constipation symptoms post-anorectal surgery. The patients will be followed up for 15 (±1 day) days after enrollment into the study. The selection of patients for the study will be totally at the discretion of the investigator, and as per the study protocol. All the patients diagnosed with symptoms of constipation post anorectal surgery, meeting inclusion and exclusion criteria, and ready to give written informed consent for study participation, are eligible for participation in this study. The study is planned to be conducted for approximately Six (6)- months.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Post-ano-rectal surgery (anal fissures, anal fistulas, and hemorrhoids) patients of either sex, in the age group of ≥18 and ≤65 years.
- •Patients having symptoms of constipation for a minimum of 3 days before the day of surgery.
- •Women of childbearing potential who had a negative pregnancy test were non-lactating and were willing to use adequate throughout the study.
- •Patients willing to comply with study procedures and requirements.
- •Patients who understood the requirements of the study and were willing to sign and date the informed consent form before participating in the study.
排除标准
- •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).
- •Pregnant or lactating women.
- •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.
- •Patients not willing to provide written informed consent to be excluded.
- •Patients with ongoing intestinal obstruction, ileus, toxic megacolon gastric retention abdominal pain, nausea or vomiting, ongoing irritable bowel syndrome (IBS) with constipation at screening.
- •Patients with history/ongoing psychiatric conditions.
- •Patients with active or cured malignancies.
- •Patients with a history of hypersensitivity to liquid paraffin, magnesium hydroxide, or sodium picosulfate.
- •Patients with any medical condition judged by investigators that warrant exclusion at screening.
- •Patients who have been on any laxatives containing, Milk of Magnesia, Liquid paraffin, and Sodium Picosulfate in the last 2 weeks.
结局指标
主要结局
1. To determine the effectiveness of fixed-dose formulation of milk of magnesia, liquid paraffin, and sodium picosulphate oral emulsion in the treatment of constipation symptoms in post-ano-rectal surgical patients.
时间窗: Day 0, 4 and 14
次要结局
- 1. To assess the treatment response in terms of bowel symptom relief after 4±2: days and 15-day treatment with fixed-dose formulation of milk of magnesia, liquid paraffin, and sodium picosulphate oral emulsion in post-ano-rectal surgical patients.(2. To determine the impact of treatment with the fixed-dose formulation of milk of magnesia, liquid paraffin, and sodium picosulphate oral emulsion on the quality of life (QoL) of patients using the Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QoL).)
研究者
Dr Pravin Gore
Piles Freedom Clinic