A Double Blind, Multi-Arm, Clinical Study to Assess the Safety and Efficacy of a Gut Health Regimen for the Management of Constipation in subjects with Mild to Severe Constipation and Irritable Bowel Syndrome with Constipation (IBS-C).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1. The change in constipation symptom severity from baseline to the end of the study period is assessed through a standardized constipation severity scale, comparing improvements in stool frequency, ease of
研究概览
简要总结
This clinical study is a double-blind, multi-arm investigation aimed at evaluating the safety and efficacy of a gut health regimen for managing constipation in individuals diagnosed with mild to severe functional constipation or irritable bowel syndrome with constipation (IBS-C). Forty subjects aged 18–60, meeting specific inclusion criteria, will be enrolled. They will receive symptom-specific products targeting gut health, including probiotics, digestive aids, and stress-relief .
The primary objective is to assess the regimen’s effectiveness in reducing constipation symptoms over 30 days, with a possible extension to 56 days if necessary. Secondary objectives include monitoring changes in bowel movement frequency, stool consistency (using the Bristol Stool Chart), and participant-reported improvements in digestive health and relief from constipation. The study will also track adverse events,if any .
Outcomes will be measured through baseline and weekly assessments, using scales like the VAS for symptom severity and the PAC-SYM questionnaire for subjective symptom relief.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •To be eligible for the study, Subjects must meet the following criteria 1.Healthy males and females aged 18–60 years.
- •2.Diagnosed with mild to severe functional constipation or IBS-C using Bristol stool scale.
- •3.Subjects willing to avoid fermented foods throughout the study duration.
- •4.No use of fiber supplementation over the month prior to the screening visit.
- •5.Able and willing to comply with the study protocol.
排除标准
- •Subjects with any of the following symptoms will be excluded from the study: 1.Presence of significant gastrointestinal pathology, including but not limited to malignancies.
- •2.Subjects with IBS-D, IBD & IBS-M.
- •3.Active or recent esophageal disease, such as severe gastroesophageal reflux disease (GERD) or esophageal strictures and Crohn’s, Piles disease etc.
- •4.Diagnosed fatty liver disease or hepatic disorders.
- •5.Active gastrointestinal ulcers or the recent history of peptic or duodenal ulcers.
- •6.Skin disorders related to immune function, such as seborrheic dermatitis.
- •7.History of major gastrointestinal surgery within the past 6 months.
- •8.Recent use of prebiotics, probiotics, Ayurvedic medications, or other supplements for constipation that significantly affect gastrointestinal motility within 2 weeks prior to screening 9.Women who are pregnant, breastfeeding, or planning pregnancy during the study period.
- •10.Evidence of current or recent (within the last 3 months) drug or alcohol abuse.
- •11.Participation in any clinical trial involving investigational products within 3 months of screening.
- •12.Recent history of acute or chronic illness that may compromise immune function or overall health.
结局指标
主要结局
1. The change in constipation symptom severity from baseline to the end of the study period is assessed through a standardized constipation severity scale, comparing improvements in stool frequency, ease of
时间窗: Baseline (T0), Day 7 (T7), Day 14 (T14), Day 21 (T21), Day 28 (T28)
bowel movements, and reduction in abdominal discomfort. (VAS Scale),
时间窗: Baseline (T0), Day 7 (T7), Day 14 (T14), Day 21 (T21), Day 28 (T28)
2. Time frame: T0, T7, T14, T21, T28
时间窗: Baseline (T0), Day 7 (T7), Day 14 (T14), Day 21 (T21), Day 28 (T28)
次要结局
- 1.Increase in the number of bowel movements per week from baseline to the end of the study period.(2.Improvement in stool consistency as measured by the Bristol Stool Chart, comparing baseline to weekly time points)
研究者
DrDipti Gupta
Tulsi Multispeciality Hospital.