Evaluation of Efficacy and Safety of the Combined Seed Extracts of Cassia Obtusifolia Linne and Foeniculum Vulgare Mill in Patients With Chronic Constipation: a Double-blind, Randomized, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in Colonic transit time during 2 weeks
研究概览
简要总结
The investigators will conduct a randomized, double-blind, placebo-controlled study to investigate the effects and safety of the combination seed extracts of Cassia obtusifolia Linne and Foeniculum vulgare Mill in patients with chronic constipation for 4 weeks.
详细描述
A previous animal study has indicated that the combined seed extracts of Cassia obtusifolia Linne and Foeniculum vulgare Mill have a laxative effect by recovering stool parameters, colonic morphology, and activation of mAchRs and their downstream signaling pathway in constipation. Furthermore, this study provides that the combined seed extracts of Cassia obtusifolia Linne and Foeniculum vulgare Mill could be considered as a therapeutic drug candidate for the prevention or treatment of constipation. Therefore, the investigators a randomized, double-blind, placebo-controlled study to investigate the effects and safety of the combination seed extracts of Cassia obtusifolia Linne and Foeniculum vulgare Mill in patients with chronic constipation for 4 weeks. The Investigators examine stool transit time, constipation Visual Analogue Scale (VAS), Bristol stool Form scale type 3 and 4 (frequency per week), VAS for Irritable Bowel Syndrome (VAS-IBS) questionnaire, IBS severity scoring system, BS Quality of Life instrument at baseline, as well as after 2 and 4 weeks of intervention. Interferon-1β and tumor necrosis factor-α concentrations were measured at baseline and 4 weeks. One hundred adults were administered either 1,000 mg of the combined seed extracts of Cassia obtusifolia Linne and Foeniculum vulgare Mill or a placebo each day for 4 weeks.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •*Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
- •**Must include two or more of the following:
- •Straining during more than ¼ (25%) of defecations
- •Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than ¼ (25%) of defecations
- •Sensation of incomplete evacuation more than ¼ (25%) of defecations
- •Sensation of anorectal obstruction/blockage more than ¼ (25%) of defecations
- •Manual maneuvers to facilitate more than ¼ (25%) of defecations (e.g., digital evacuation, support of the pelvic floor)
- •Fewer than three spontaneous bowel movements per week
- •Loose stools are rarely present without the use of laxatives
- •Insufficient criteria for irritable bowel syndrome
排除标准
- •A person who is taking a constipation treatment prescribed by a doctor within 1 month from the date of screening
- •Those who have been taking lactobacillus or probiotics within the last 1 month
- •Those with secondary constipation induced by drugs or diseases.
- •Abnormal liver or renal function (more than twice the normal upper limit of the research institute)
- •Uncontrolled diabetes mellitus (>160 mg/dL of fasting blood sugar)
- •Uncontrolled hypertension (>160/100 mmHg)
- •Uncontrolled thyroid diseases.
- •Those who are taking drugs, functional foods, herbs, etc. that may affect depression
- •Alcohol abuser
- •Allergic reaction to this test food
- •Those who participated in other drug clinical trials within 1 month from the screening date.
- •Severe gastrointestinal symptoms such as heartburn and indigestion
- •Those who are pregnant, lactating, or plan to become pregnant during the clinical trial
- •Those who are judged to be unsuitable by the PI for other reasons
结局指标
主要结局
Change in Colonic transit time during 2 weeks
时间窗: At the 2nd weeks after the start of the study
The number of retained radiopaque markers on a Day 4 plain abdominal film
Change in Colonic transit time during 4 weeks
时间窗: At the 4th weeks after the start of the study
The number of retained radiopaque markers on a Day 4 plain abdominal film
次要结局
- Change in Interferon-1β during 4 weeks(At 4th weeks after the start of the study)
- Change in Constipation Visual Analogue Scale during 2 weeks(At the 2nd weeks after the start of the study)
- Change in Irritable Bowel Syndrome severity scoring system during 2 weeks(At the 2nd weeks after the start of the study)
- Change in Visual Analogue Scale for Irritable Bowel Syndrome during 4 weeks(At the 4th weeks after the start of the study)
- Change in Visual Analogue Scale for Irritable Bowel Syndrome during 2 weeks(At the 2nd weeks after the start of the study)
- Change in Tumor necrosis factor-α during 4 weeks(At 4th weeks after the start of the study)
- Change in Constipation Visual Analogue Scale during 4 weeks(At the 4th weeks after the start of the study)
- Change in Bristol stool Form scale type 3 and 4 (frequency per week) during 2 weeks(At the 2nd weeks after the start of the study)
- Change in Irritable Bowel Syndrome Quality of Life instrument during 2 weeks(At the 2nd weeks after the start of the study)
- Change in Bristol stool Form scale type 3 and 4 (frequency per week) during 4 weeks(At the 4th weeks after the start of the study)
- Change in Irritable Bowel Syndrome severity scoring system during 4 weeks(At the 4th weeks after the start of the study)
- Change in Irritable Bowel Syndrome Quality of Life instrument during 4 weeks(At the 4th weeks after the start of the study)
研究者
Sang Yeoup Lee
Professor
Pusan National University Yangsan Hospital