Table 1 WHO trial registration data set—structured summary
Data category | Information |
|---|---|
Primary registry, trial identifying number | ClinicalTrials.gov (NCT03457324) |
Date of registration in primary registry | February 8, 2018 |
Secondary identifying numbers | Â |
Sources of monetary support | Innovative Technology Commission of the government of Hong Kong Special Administrative Region |
Contact for public queries | ZXB, MD, PHD [bzxiang@hkbu.edu.hk] |
Contact for scientific queries | ZXB, MD, PHD [bzxiang@hkbu.edu.hk] |
Public title | Efficacy and Safety of Chinese Medicine JCM-16021 for Diarrhea-predominant Irritable Bowel Syndrome |
Scientific title | Efficacy and Safety of Chinese Medicine JCM-16021 for Diarrhea-predominant Irritable Bowel Syndrome: Study protocol for a Multi-center, Randomized, Double-blind, Placebo Controlled Clinical Trial |
Country of recruitment | Hong Kong, China |
Health problem | Diarrhea-predominant Irritable Bowel Syndrome |
Intervention(s) | Experimental group: JCM-16021 granules (8Â g/sachet for each time, three times daily for 8Â weeks) |
Control group: Placebo granules (8Â g/sachet for each time, three times daily for 8Â weeks) | |
Key inclusion and exclusion criteria | Inclusion criteria: (1) the diagnosis criteria of IBS-D; (2) the diagnosis of LSSD; (3) Age of 18–65 years; (4) with written informed consent |
Exclusion criteria: (1) Constipation predominant, mixed or unsubtyped IBS; (2) Abnormal colonoscopy within 5 years (except for benign polypectomy or hemorrhoids); (3) With severe diseases on the system of heart, lung, liver, and kidney which are diagnosed by TCM theory; (4) Concomitant diabetes, Glucose-6-Phosphate Dehydrogenase deficiency, unstable hypertension, malignant tumor or have undergone thyroid surgery or medication within a year; (5) With diseases on the spleen-stomach system or other diseases that affect the movement of qi on the spleen-stomach system, which are diagnosed by TCM theory; (6) 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); (7) Medical history of gastrointestinal surgery (except for appendicitis surgery); (8) The serum levels of alanine transaminase (ALT), aspartate transaminase(AST), and creatinine(Cr) exceed 1.5 times of the reference limit; (9) History of allergy in Chinese medicine; (10) Women in pregnancy or breast-feeding; (11) Medical history of neurological diseases or psychiatric disorders; (12) Currently participating in another clinical trial; (13) Taking IBS treatment drugs within 1 week | |
Study type | Interventional allocation: randomized |
Intervention model: parallel assignment | |
Masking: double blind (participants and Physicians, Chinese Medicine Practitioners and research assistants) | |
Primary purpose: Treatment | |
Phase III | |
Date of first enrollment | October 2018 |
Target sample size | 392 |
Recruitment status | Completed |
Primary outcome | The improvement rate on the Global Assessment of Improvement (GAI) at week 10 |
Key secondary outcomes | Changes of IBS symptoms, TCM pattern improvement, IBS-Quality of Life (IBS-QoL), IBS-Symptom Severity Score (IBS-SSS), safety |