A randomised, double-blind, placebo-controlled clinical trial to determine the effects of MaZiRenWan granules on functional constipation and constipation-predominant irritable bowel syndrome

Not Applicable

• Conditions: Functional Constipation and Constipation-Predominant Irritable Bowel Syndrome

• Registration Number: ITMCTR2100004417
• Lead Sponsor: Hong Kong Baptist University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

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:
- 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.

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
- 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

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Complete Spontaneous Bowel Movement (CSBM) respond rate;

Secondary Outcome Measures

Name	Time	Method
IBS symptom severity, based on the scores of irritable bowel syndrome-symptom severity score (IBS-SSS) in the IBS-C group;The CSBM respond rate;Spontaneous Bowel Movement (SBM) frequency;Colonic transit time (CTT);Fecal microbiota structure;Constipation symptoms and quality of life, based on the scores of Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire and Patient Assessment of Constipation Quality of Life (PAC-QoL) questionnaire, respectively.;Abnormal result rate in glucose breath test;Abdominal Pain Responder rate in the IBS-C group;Symptoms of depression and anxiety, based on the scores of Zung's Self-rating Depression Scale (SDS) and Zung's Self-rating Anxiety Scale (SAS), respectively.;Colonic mucosal microbiota structure;