ITMCTR2100004417
Not yet recruiting
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
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Hong Kong Baptist University
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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:
Exclusion Criteria
- •\- 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
Outcomes
Primary Outcomes
Not specified
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