Efficacy and Safety of Chinese Medicine JCM-16021 for Diarrhea-predominant Irritable Bowel Syndrome
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|ClinicalTrials.gov Identifier: NCT03457324|
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : August 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome||Drug: JCM-16021 Drug: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||392 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy and Safety of Chinese Medicine JCM-16021 for Diarrhea-predominant Irritable Bowel Syndrome: a Multicenter, Randomized, Double-blind, Placebo Controlled Clinical Trial|
|Actual Study Start Date :||November 8, 2018|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||June 30, 2021|
Experimental: JCM-16021 Group
JCM-16021 granules 8g/sachet, three times daily for 8 weeks.
This prescription with seven ingredients.
Placebo Comparator: Placebo Group
Placebo granules 8g/sachet, three times daily for 8 weeks
- Global Assessment of Improvement (GAI) score [ Time Frame: 16 weeks ]The global symptom improvement will be evaluated by scales (terrible=0, worse=1, slightly worse=2, no change=3, slightly better=4, better=5, excellent=6).
- Pain responder rate in daily worst abdominal pain scores [ Time Frame: 16 weeks ]Pain responders are defined as that participants who met the daily pain response criteria for at least 50% of the days with diary entries during the observational period of interest. Daily pain response: decrease in the worst abdominal pain scores in the past 24 hours of ≥ 30% compared to baseline (average of daily worst abdominal pain the 2-week prior to randomization). Pain score is ranked from 0 to 10 represented none to most severe.
- Stool consistency responder rate In daily stool consistency scores [ Time Frame: 16 weeks ]Stool consistency responders are defined as that participants who met daily stool consistency response criterion (ie, score of 1, 2, 3, or 4 or absence of bowel movement if accompanied by ≥30% decrease in worst abdominal pain scores compared to baseline pain) for at least 50% of days with diary entries during the observational period of interest. Bristol stool scale is defined as 7-point Scale in which a score of 1 = separate hard lumps, 2 = sausage shaped but lumpy, 3 = sausage-like with cracks on the surface, 4 = sausage-like but smooth and soft, 5 = soft blobs with clear cut edges, 6 = fluffy pieces with ragged edges, and 7 = watery with no solid pieces.
- Efficacy judgement standard of single symptom [ Time Frame: 16 weeks ]
- Excellent: symptom disappearing;
- Effective: symptom decreased, scoring declining more than 2 points (including 2 points);
- Helpful: symptom decreased, scoring declining between 1 point to 2 points;
- Invalid: no change in symptom. Improvement contains excellent, effective and helpful. Each cardinal symptom total improvement rate will be calculated and then conducted symptom evaluation.
- Comprehensive efficacy judgement standard of cardinal symptoms [ Time Frame: 16 weeks ]The symptom improvement rate is calculated by "(total scoring of prior treatment - total scoring of post treatment) / total scoring of prior treatment × 100%". Clinical remission is defined as symptom disappearing, symptom improvement rate equal or greater than 80% is excellent, symptom improvement rate between 50% and 80% is helpful, symptom improvement rate under 50% is invalid, and negative symptom improvement rate is deterioration. Total effective rate is based on recovery and excellent cases.
- TCM pattern improvement [ Time Frame: 16 weeks ]Clinical remission: clinical symptoms and signs disappear or basically disappear, total scoring declining ≥95%; Excellence: clinical symptoms and signs are significantly improved, total scoring declining ≥ 70%; Effective: clinical symptoms and signs are improved, total scoring declining ≥ 30%; Invalid: clinical symptoms and signs are without obvious improvement or even with exacerbation, total scoring declining < 30%. Remark: calculation formula (nimodipine method) is: [(scoring of prior treatment - scoring of post treatment) / scoring of prior treatment]×100%
- Quality of life scoring (IBS-QoL) [ Time Frame: 16 weeks ]IBS-QoL includes 34 items and divides into 8 subscales, i.e. dysphoria (Q1), interference with activity (Q2), body image (Q3), health worry (Q4), food avoidance (Q5), social reaction (Q6), sexual (Q7) and relationship (Q8). Each item has a five-point response scale with reverse scoring. After conversion, total scoring will be in 0-100 range. Higher scoring reflects superior quality of life.
- Irritable Bowel Syndromes-Symptom Severity Score (IBS-SSS) [ Time Frame: 16 weeks ]The IBS-SSS is involved five aspects: the severity of abdominal pain, the frequency of abdominal pain, the severity of abdominal discomfort, defecation satisfaction, and interference with daily life. The range of score is 0-500 points scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03457324
|Contact: Zhaoxiang Bian, ph.D||34112905 ext firstname.lastname@example.org|
|China, Hong Kong|
|Chinese Medicine Clinics of Hong Kong Baptist University||Recruiting|
|Hong Kong, Hong Kong, China|
|Contact: Zhao-xiang Bian, PhD 852-34112905 email@example.com|
|Institute of Digestive Disease, The Chinese University of Hong Kong||Not yet recruiting|
|Hong Kong, China|
|Contact: Justin Wu, M.D 2632 3524 firstname.lastname@example.org|
|Principal Investigator:||Justin Wu, M.D.||Chinese University of Hong Kong|