Functional Constipation and Constipation-Predominant Irritable Bowel Syndrome
Conditions
Interventions
MZRW for IBS-C group:MZRW granule
Placebo for FC group:MZRW placebo granule
Placebo for IBS-C group:MZRW placebo granule
MZRW for FC group:MZRW granule
Sponsors
Hong Kong Baptist University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion 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: - 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Complete Spontaneous Bowel Movement (CSBM) respond rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 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; | — |
Countries
China
Contacts
Public ContactZhaoxiang Bian
Hong Kong Baptist University
Outcome results
None listed