CTRI/2025/11/098194尚未招募不适用
A randomized, double blind, placebo controlled, parallel study to evaluate the efficacy and safety of AS Gel On patients suffering from Mild to Moderate Constipation.
PR Nine Co., Ltd.2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年1月8日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 2
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, parallel study designed to evaluate the efficacy and safety of AS Gel in patients with mild to moderate constipation. The study will assess improvements in Constipation Scoring System (CSS) scores and abdominal pain as primary endpoints, along with the number of spontaneous bowel movements and overall safety and tolerability as secondary endpoints. The study aims to determine whether AS Gel is a safe and effective treatment for relieving constipation symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female individuals age from 18-60 (both inclusive).
- •Subjects suffering from mild to moderate constipation from last two weeks.
- •Subjects who have less than 3 bowel movements per week for at least 2 weeks
- •Subjects who agree to maintain their usual level of activity throughout the trial period
- •Those who voluntarily agree to participate and signs the informed consent form
- •Subjects shall be willing and able to understand and comply with the requirements of the study, consume the study IP as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study.
排除标准
- •Pregnant and breastfeeding subjects have undergone any surgery and have taken part in any clinical Trial.
- •Significant history or presence of gastrointestinal, liver, or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism, or excretion of common medications
- •Not willing to sign the ICF or give the consent.
- •Having hypersensitivity or history of allergy to the study product.
- •Suffering from a metabolic disorder
- •Subjects diagnosed with functional constipation as per Rome III criteria
- •Major gastrointestinal complication.
研究者
Dr Venkatesh S
Vagus Super Speciality Hospital Pvt.Ltd.
研究点 (2)
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