Efficacy and Safety of Chinese Medicine JCM-16021 for Diarrhea-predominant Irritable Bowel Syndrome: a Multicenter, Randomized, Double-blind, Placebo Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 392
- 试验地点
- 2
- 主要终点
- Global Assessment of Improvement (GAI) score
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo controlled clinical trial, in order to evaluate the efficacy and safety of Chinese Medicine JCM-16021 for diarrhea-predominant irritable bowel syndrome. All patients will be evaluated for study eligibility at Visits 1 (baseline) and 2 (2 weeks). On visit 2, patients who meet the criteria will be randomly assigned to receive 8-week treatment of either JCM-16021 Granules or JCM-16021 placebo Granules. The investigators, research assistants and participants are not aware of the treatment assignments throughout the study. Treatment codes will only be broken after the completion of study. The assessments at Visit 3 (4-week post treatment) and at visit 4 (end of 8-week treatment) are used to measure treatment response (i.e. changes from baseline). Assessment at visit 5 (end of 8-week follow up) is to determine any sustained response to treatment. All the visits will be carried out in HKBU and CUHK clinics.
详细描述
Sample size calculation:
Sample size is calculated on the basis of primary efficacy variables. From our previous study, the global assessment of improvement (GAI) were 52% in herbal medicine group and 32% in western medicine group, respectively. According to the references (Corazziari E, Bytzer P, Delvaux M, et al. Clinical trial guidelines for pharmacological treatment of irritable bowel syndrome. Alimentary pharmacology & therapeutics 2003; 18 (6): 569-580), the investigational drug is more effective than placebo (the overall improvement rate of symptoms is 15%), using StudySize2.0 software to calculate the sample size, assuming the improvement in the treatment group is 52%. In order to detect a difference with a two-side p value <0.05 and 80% statistical power, we will need to recruit 166 patients per arm. Further assuming a 15% dropout rate, we conclude that a total of 392 patients (196 per arm) will be recruited to ensure statistically significant results.For the number of cases distribution between centers, according to the references (Lai D,Chang KC, Rahbar MH, Moye LA. Optimal Allocation of Sample Sizes to Multicenter Clinical Trials. Journal of biopharmaceutical statistics 2013; 23 (4): 818-828) , from the following equation, we will consider the center about the patient flow, traffic, treatment,costs and other possible factors, we will use the formula below to estimate the number of cases that will be recruited in each center.
Research medical record and Electronic Database:
All patients should be observed and assessed based on clinical trial protocol and the investigators need to document in the medical record accurately and clearly. Research medical record is the source document which cannot be altered. Any correction should not change the original record and can only be added in a way of narration with reasons. The doctor participated in the clinical trial needs to sign and date the record. An electronic database will be created. Each study site will input their own data and be responsible for its accuracy. A chief statistician will be responsible for data cleaning and data analysis.
Analysis parameters:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •fulfill the diagnostic criteria of diarrhea-predominant IBS (IBS-D);
- •fulfill the diagnostic criteria of diarrhea with TCM pattern of liver depression and spleen deficiency (LDSD);
- •age of 18-65 years (inclusive);
- •participants are voluntary and provide written informed consent.
排除标准
- •constipation-predominant, mixed or unsubtyped IBS patients;
- •severe diseases on heart, liver and kidney, hematology or cancer which is diagnosed by traditional Chinese medicines;
- •medical history of organic gastrointestinal diseases (e.g. inflammatory bowel diseases, intestinal tuberculosis, colon polyps), or systemic diseases which could affect gastrointestinal motility (e.g. hyperthyroidism, diabetes mellitus, chronic renal failure, neuropsychiatric diseases) which is diagnosed by traditional Chinese medicines;
- •current concomitant medication with effects on gastrointestinal function (e.g. anticholinergic drugs, calcium channel blockers, 5-HT3 receptor antagonists, antidiarrheal agents, antacids, prokinetic agents, antidepressants, anxiolytics and intestinal flora regulating drugs);
- •medical history of abdominal surgery (e.g. cholecystectomy, etc.);
- •drug or food allergies;
- •pregnancy or breast-feeding;
- •medical history of neurological diseases or psychiatric disorders;
- •currently participating in another clinical trial;
- •taking IBS treatment drugs within 1 week.
研究组 & 干预措施
JCM-16021 Group
JCM-16021 granules 8g/sachet, three times daily for 8 weeks.
干预措施: JCM-16021 (Drug)
Placebo Group
Placebo granules 8g/sachet, three times daily for 8 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Global Assessment of Improvement (GAI) score
时间窗: 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).
次要结局
- Pain responder rate in daily worst abdominal pain scores(16 weeks)
- Stool consistency responder rate In daily stool consistency scores(16 weeks)
- Efficacy judgement standard of single symptom(16 weeks)
- Comprehensive efficacy judgement standard of cardinal symptoms(16 weeks)
- TCM pattern improvement(16 weeks)
- Quality of life scoring (IBS-QoL)(16 weeks)
- Irritable Bowel Syndromes-Symptom Severity Score (IBS-SSS)(16 weeks)
研究者
ZhaoXiang Bian
Chair Professor of Clinical Division
Hong Kong Baptist University