Functional Constipation Clinical Trial
Official title:
Chinese Herbal Medicine (MaZhiRenWan) for Functional Constipation: a Prospective, Double-blinded, Double-dummy, Randomized Controlled Study
NCT number | NCT01695850 |
Other study ID # | HHSRF09101501 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | June 2013 |
Est. completion date | August 2015 |
Verified date | May 2020 |
Source | Hong Kong Baptist University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this study is to evaluate the efficacy and safety of a Chinese herbal proprietary medicine, MaZiRenWan (MZRW), by comparing with stimulant laxative western medicine (WM), senna, and placebo for patients with functional constipation (FC) in excessive TCM syndrome.
Status | Completed |
Enrollment | 291 |
Est. completion date | August 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - either gender aged 18 to 65 years - have FC diagnosed as Rome III criterial - have diagnosis of Excessive Constipation according to the TCM theory - complete spontaneous bowel movement (CSBM) ?2times/w - severity of constipation?3pts (7 pts scale from 0 to 6pts) and the overall scoring of constipation-related symptoms?6pts (6items in 7pts scale) for self symptom assessment in the run-in period - normal colonic evaluation (colonoscopy or barium enema) within 12 months - normal liver and renal function in blood test within 3 months Exclusion Criteria: - drug-induced constipation - secondary causes of constipation (i.e. medical history of diabetes mellitus and thyroid disease) - abdominal surgery (i.e. Caesarean operation) - severe diseases (i.e. cancer and acute present asthma) - allergy to CHM (i.e. G6PD deficiency), senna and tartrazine - pregnancy or breast-feeding - psychiatric or addictive disorders |
Country | Name | City | State |
---|---|---|---|
China | School of Chinese Medicine, Hong Kong Baptist University | Hong Kong | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Hong Kong Baptist University | Prince of Wales Hospital, Shatin, Hong Kong, Queen Elizabeth Hospital, Hong Kong |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the responder rate for CSBM during the treatment period | a clinically meaningful endpoint by combining an objective measure (number of bowel movement) with a subjective measure (feelings of patients as to completeness of defecation,Patients with a mean increase of ?1 complete spontaneous bowel movement(CSBM)/wk compared with the baseline(wk1-2) will be defined as responders | 8 weeks | |
Secondary | the responder rate for CSBM during the follow-up period | Participants with a mean increase of complete spontaneous bowel movement (CSBM)>=1 movement per week compared with the last 14 days of the run-in period were defined as responders | 8 weeks | |
Secondary | Individual assessment of constipation and related symptoms | severity of constipation, sensation of straining, incomplete evacuation, bloating, abdominal pain / cramping, nausea, and passing of gas) was recorded using a 7-point ordinal scale (0 = not at all and 6 = very severe | 18 weeks | |
Secondary | the changes of colonic transit time | It is estimated by using a commercially available radio-opaque Sitzmarks capsule (Konsyl Pharmaceuticals, US). Each gelatine capsule contained 24 barium sulphate embedded polyvinyl chloride markers measuring 1mmx4.5mm. Plain radiographs of the abdomen will be obtained after the swallow of capsule for five days (120 hours) before and after 8 weeks treatment period. | 18 weeks | |
Secondary | Global symptom assessment | Participants were asked to rate their impression of change in constipation by comparing with their baseline (Wk2) at the visits during the treatment (Wk6), end of treatment (Wk10) and end of follow-up (Wk18) with scores from 0 to 6 represented markedly worse or better respectively. The response categories were collapsed to simply "improved" for score 4 to 6, "same" for score 3 or "worse" for score 0 to 2. | 18 weeks | |
Secondary | Success of blinding | the success of blinding is evaluated for both investigator and patients as to whether CHM, WM or placebo had been taken | 18 weeks | |
Secondary | safety profiles | Assessed by determining the important adverse events reported in the participants ' diaries, follow-up interviews,and clinical laboratory evaluationse.g., liver and renal function. | 18 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04506801 -
The Effect of Probiotics on Functional Constipation in the Elderly
|
N/A | |
Completed |
NCT04620161 -
A Proof of Concept Study of Pradigastat in Patients With Functional Constipation
|
Phase 2 | |
Active, not recruiting |
NCT02361749 -
Botulinum Toxin Injection Versus Anal Myectomy in Management of Idiopathic Constipation
|
Phase 4 | |
Completed |
NCT03054805 -
The Effect of Probiotics on Constipation, and Intestinal Microflora in Children With Functional Constipation
|
Phase 4 | |
Not yet recruiting |
NCT01913665 -
The Effect of Bifidobacterium Lactis and Inulin on Functional Constipation
|
N/A | |
Completed |
NCT01348152 -
Effect of TU-100 in Patients With Functional Constipation
|
Phase 2 | |
Completed |
NCT01622972 -
Mode of Action of Moviprep
|
Phase 4 | |
Completed |
NCT01212146 -
Probiotic-enriched Artichoke in Functional Constipation
|
N/A | |
Completed |
NCT04231162 -
Effect of an 8-week Bifidobacterium Lactis HN019 Supplementation on Functional Constipation
|
N/A | |
Not yet recruiting |
NCT03639142 -
Dried Plums (Prunes) vs. Polyethylene Glycol 4000 for Treatment of Functional Constipation in Children
|
Phase 3 | |
Recruiting |
NCT04918329 -
Functional Digestive Disorders Observatory
|
||
Completed |
NCT02592200 -
Effect of Lactobacillus Gasseri DSM 27123 on Functional Constipation in Healthy Women
|
N/A | |
Completed |
NCT03707002 -
Effect of scFOS on Increase in Stool Frequency in Constipated People
|
N/A | |
Recruiting |
NCT06083311 -
The Efficacy of a Probiotic for Functional Constipation (FC)
|
N/A | |
Completed |
NCT04110145 -
Linaclotide Safety and Efficacy in 2 to 5-Year-Old Participants With Functional Constipation
|
Phase 2 | |
Recruiting |
NCT06196073 -
Visceral Osteopathy in Functional Constipation
|
N/A | |
Completed |
NCT04026113 -
Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC)
|
Phase 3 | |
Completed |
NCT02359396 -
A Randomized, Open-label, Three-arm Study of MZRW on Tolerability, Exposure and Pharmacokinetics
|
Phase 1 | |
Completed |
NCT01847950 -
Effects of scFOS on Stool Frequency in People With Functionnal Constipation
|
N/A | |
Recruiting |
NCT01274793 -
Trial for Quantity-Effect Relationship of Acupuncture With Two-ways Regulation to Treat Functional Enteropathy
|
Phase 1 |