ChiCTR2100043211尚未招募Unknown
A Multicenter, Randomized, Double-Blind, Placebo-Control Clinical Trial to Uncover the Actions and the Mechanisms of MaZiRenWan (MZRW) for Functional Constipation and Constipation-Predominant Irritable Bowel Syndrome
Health@InnoHK Initiative Fund of the Hong Kong Special Administrative Region Government (ITC RC/IHK/4/7)4 个研究点 分布在 1 个国家开始时间: 2021年5月1日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 试验地点
- 4
- 主要终点
- The Complete Spontaneous Bowel Movement (CSBM) respond rate
研究概览
简要总结
This study aims to determine 1) the efficacy and safety of MZRW in IBS-C patients; 2) whether and how gut microbiota mediates the ameliorative effects of MZRW in FC and IBS-C spectrum; and 3) whether MZRW will take effect on patients through modulating gut dysbiosis.
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
- 盲法
- Double
入排标准
- 年龄范围
- 18 至 65（—）
- 性别
- All
入选标准
- •FC subjects:
- •Meet the diagnostic criteria for functional constipation based on Rome IV criteria;
- •Aged 18 to 65 years;
- •Signed an informed Consent Form (ICF);
- •Complete spontaneous bowel movement (CSBM) <= 2 times/week (CSBM is defined by feeling of complete passage of stool and without the use of laxatives or enemas within 24 hours);
- •Meet protocol-defined e-Diary completion compliance and agree to refrain from making any new, major life-style changes that may affect FC symptoms;
- •No clinical significance of colonoscopy examination findings.
- •IBS-C subjects:
- •The diagnostic criteria for constipation-predominant irritable bowel syndrome based on Rome IV criteria;
- •Aged 18 to 65 years;
- •Signed an informed Consent Form (ICF);
- •Complete spontaneous bowel movement (CSBM) <= 2 times/week (CSBM is defined by feeling of complete passage of stool and without the use of laxatives or enemas within 24 hours);
- •Abdominal pain intensity: weekly average of worst daily (in past 24 hours) abdominal pain score of >= 3.0 on a 0 to 10 point scale;
- •Irritable bowel syndrome-symptom severity score (IBS-SSS) >= 175.34;
- •Meet protocol-defined e-Diary completion compliance and agree to refrain from making any new, major life-style changes that may affect IBS-C symptoms;
- •No clinical significance of colonoscopy examination findings.
排除标准
- •Both IBS-C and FC subjects:
- •Drug-induced or secondary causes of constipation;
- •Recent history of mushy or watery stools within one month;
- •Known diagnosis of inflammatory bowel disease, celiac disease, microscopic colitis or other gut inflammatory condition;
- •Must use drugs that may adversely affect the study result during the study period (including but not limited to antibiotic, steroid, analgesic drug, neuromodulator, prebiotic, symbiotic, or probiotic drugs);
- •Severe depression and/or anxiety level (Zung Self-rating Depression Scale (SDS)>= 70 and/or Zung Self-rating Anxiety Scale (SAS) >= 60, and/or Hamilton depression rating scale (HAM-D) >= 19 and/or Hamilton anxiety rating scale (HAM-A) >= 25);
- •Clinical significance of laboratory or imaging tests findings;
- •Allergy to Chinese herbal medicine;
- •Prior medical history of abdominal surgeries within one year;
- •Pregnancy or plans to pregnant or breast-feeding with the study time frame;
- •Frequent alcohol consumption (>= 3 times per week and/or >= 2 drinks categories per session and/or >=3 drinks categories per weekly) consumption;
- •Vulnerable adults;
- •Any other disease(s), condition(s) or habit(s) that would interfere with completion of the study, or in the judgment of the investigator that the patients condition would potentially interfere compliance to this study or would adversely affect study outcomes.
研究组 & 干预措施
MZRW for FC group
Placebo for FC group
MZRW for IBS-C group
Placebo for IBS-C group
结局指标
主要结局
The Complete Spontaneous Bowel Movement (CSBM) respond rate
时间窗: from baseline to treatment period, 8 weeks
次要结局
- The CSBM respond rate(8 weeks intervention period and 8 weeks follow-up period)
- Abdominal Pain Weekly Responder in IBS-C group(8 weeks intervention period and 8 weeks follow-up period)
- Change from baseline in 8-week CSBM and SBM frequency rate(baseline and 8-week treatment period)
- Change from baseline in 8-week irritable bowel syndrome-symptom severity score (IBS-SSS) score in IBS-C group(from baseline to treatment period, 8 weeks)
- Change from baseline in 8-week Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire and Patient Assessment of Constipation Quality of Life (PAC-QoL) questionnaire(from baseline to treatment period, 8 weeks)
研究者
研究点 (4)
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