ITMCTR2100004417尚未招募未知
A randomised, double-blind, placebo-controlled clinical trial to determine the effects of MaZiRenWan granules on functional constipation and constipation-predominant irritable bowel syndrome
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 65（—）
- 性别
- All
入选标准
- •a) All participants:
- •- Aged between 18 and 65 (inclusive)
- •- Understand and be able to follow written and oral instructions in Chinese
- •- Provide informed consent
- •- CSBM = 2 times/week (based on the 2-week e-diary in screening)
- •- Clinical diagnosed with constipation with excessive Pattern based on the Traditional Chinese Medicine (TCM) theory (Table 2)
- •b) FC group only:
- •- Clinically diagnosed with FC based on the ROME IV criteria
- •- CSBM = 2 times/week (based on the 2-week e-diary in screening)
- •c) IBS-C group only:
- •- Clinically diagnosed with IBS-C based on the ROME IV criteria
- •- CSBM = 2 times/week (based on the 2-week e-diary in screening)
- •- Abdominal pain intensity: weekly average of the worst daily (in the 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
- •ROME IV criteria for IBS-C and FC are provided in the protocol.
- •Any three of the following chief symptom manifestations of Heat and/or Qi stagnation:
- •(1) Dry and hard stools;
- •(2) Difficult bowel movements;
- •(3) Abdominal distension, with or without tenderness;
- •(4) Belching;
- •(5) Dry mouth or halitosis;
- •(6) Red tongue with dry and/or yellow coating; and
- •(7) Wiry pulse.
排除标准
- •- 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
- •- Use of medications and/or supplements that may confound the study outcomes (including but not limited to antibiotics, steroid, analgesic drug, neuromodulator, prebiotics, symbiotics, or probiotics)
- •- Severe depression and/or anxiety level (Zung Self-rating Depression Scale (SDS)=70 and/or Zung Self-rating Anxiety Scale (SAS) =60)
- •- Clinically significant colonoscopy or sigmoidoscopy examination findings within the past 5 years
- •- Clinically significant laboratory or imaging findings
- •- Known allergic reactions to the ingredients in MZRW and/or placebo
- •- Abdominal surgeries within the past year (except laparoscopic appendectomy)
- •- Pregnancy, breastfeeding or plan to become pregnant with the study timeframe
- •- Frequent alcohol consumption (=3 times per week)
- •- Vulnerable adults (i.e. mentally or physically disabled to take care of himself/herself)
- •- Any disease(s), condition(s) or habit(s) deemed by the investigators that would prevent participation in the study, e.g. participation in past or active clinical research, at the discretion of the investigators
- •- Any disease(s), condition(s) or habit(s) deemed by the investigators that would compromise the individuals ability to complete the study, e.g. serious psychiatric conditions, at the discretion of the investigators
研究者
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