Randomised Clinical Trial: Enteric-coated Anise-oil Capsules vs. Placebo & Active Controlled in Irritable Bowel Syndrome - A 4 Week Double-blind Study With 2 Weeks Follow-up
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Composite of Quality of Life (QOL), pain, flatulence, diarrhea, constipation, reflux, headache and tiredness
研究概览
简要总结
Colpermin ® (Peppermint oil) is used in the treatment of Irritable Bowel Syndrome but Peppermint (Mentha x piperita) isn't native in Iran. So in this study the Enteric-Coated of Anise-oil will formulate and use in treatment of Irritable Bowel Syndrome with pain and bloating.
详细描述
The purpose of this study is to assess the efficacy of Enteric-coated Anise-oil capsules comparing with placebo and Colpermin® for treatment of IBS patients. 120 patients with confirmed IBS with non-response criteria selected. In this double blind pilot study, the patients and researchers will be blinded about Receiving Drug, Placebo and Active allocation. Patients will be randomized into group A (Anise-oil EC Capsule 187 mg daily, for 4 weeks), group B (placebo Capsule once daily, for 4 weeks) and group B (Colpermin® Capsule once daily, for 4 weeks). At the end of therapy (4 weeks) and at baseline (first), 2 weeks after receiving drug, placebo and Colpermin® IBS load, will be evaluated and compared between groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Meeting the Rome III Modular Questionnaire
- •Patients with 50 years were required to have a colonoscopy performed within the previous 5 years
- •Patients under the age of 50 years were required to have a sigmoidoscopy performed
排除标准
- •Unable or unwilling patients to use an acceptable method of birth control
- •Pregnant or nursing females
- •Previous gastrointestinal or abdominal surgery (except for common causes unrelated to IBS)
- •Organic disorder of the large or small bowel (e.g. ulcerative colitis, Crohn's disease)
- •Mechanical obstruction
- •Unexplained significant weight loss or rectal bleeding
- •Diagnosis of any medical condition associated with constipation (other than IBS)
- •Abnormal laboratory tests
- •Abuse of alcohol or drugs
研究组 & 干预措施
Anise-oil EC
Intervention Group: Anise-oil EC Capsule,One Cap(187mg)/day for 4 weeks. Patients will be Followed at Baseline, 4 and 6 Weeks after Starting Intervention.
干预措施: Anise-oil EC Capsule (Drug)
Placebo
Placebo Group: One Placebo Capsule/Day for 4 Weeks. Patients Will be Followed at Baseline, 4 and 6 Weeks after Starting Intervention.
干预措施: Placebo (Other)
Colpermin®
Colpermin® Group: One Colpermin® Capsule/Day for 4 Weeks. Patients Will be Followed at Baseline, 4 and 6 Weeks after Starting Intervention.
干预措施: Colpermin® (Drug)
结局指标
主要结局
Composite of Quality of Life (QOL), pain, flatulence, diarrhea, constipation, reflux, headache and tiredness
时间窗: Baseline
(IBS-QOL) questionnaire and 10-point visual scale ranging
次要结局
- Composite of Change in Quality of Life (QOL), pain, flatulence, diarrhea, constipation, reflux, headache and tiredness at end of treatment(End of Follow Up(6 weeks after staring intervention))
研究者
Dr. Maryam Mosaffa-Jahromi
PharmD., PhDc of Traditional Pharmacy
Shiraz University of Medical Sciences