Diarrhea-predominant irritable bowel syndrome
Conditions
Interventions
Group 1:Take Chang-Ji-An Capsule
control group:Take Chang-Ji-An Capsule placebo
Sponsors
Beijing Chinese Medicine Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. The subject meets the western diagnostic criteria for diarrhea-predominant irritable bowel syndrome; 2. The subject meets the Chinese medicine syndrome standard of liver and spleen syndrome; 3. Aged 18-65 years male and female; 4. The three NRS scores for the most severe abdominal pain, bloating and abdominal discomfort per day in the last week of the run-in period were recorded separately, with at least one of the above three matching the weekly average of numerical rating scale (NRS) scores (e.g., the mean abdominal pain NRS scores was calculated as: the sum of daily abdominal pain NRS data for seven consecutive days/actual abdominal pain days occurring during the week, same calculation methods for the other two scores) greater than or equal to 3 (11-point NRS); meanwhile, stool characteristics were found at least 2 days per week and at least once a day for Bristol Stool Form Scale Type 6 or 7; 5. SAS < 60 points,SDS < 63 points; 6. Subjects got a colonoscopy in the first-class tertiary hospital within 12 months before the run-in period, and colonoscopy results showed no obvious abnormality (including diverticulum, chronic inflammation) or were diagnosed with colonic polyps; 7. The subject voluntarily participate in this clinical trial and voluntarily sign informed consent form.
Exclusion criteria
Exclusion criteria: 1. The polyp size > 0.5 cm diagnose by colonoscopic without resection, or intestinal polyposis syndrome; 2. The subject had used other IBS drugs in the previous 1 week screened; 3. Non-IBS-D and patients with other digestive systemic diseases, or abdominal pain, abdominal discomfort caused by other organic lesions; 4. Combined with diabetes, hyperthyroidism, or serious primary diseases such as cardiovascular, cerebrovascular, liver, kidney, hematopoietic system, or serious diseases that affect their survival (such as tumors), liver and kidney dysfunction (AST, TBIL;>;1.5 times the upper limit of normal reference, Scr exceeds the upper limit of the normal range), and clinically significant ECG abnormalities; 5. Moderate or severe depression or anxiety, mentally ill; 6. The subject had gastrointestinal surgery before; 7. The subject is taking or need to continue to take drugs that may affect gastrointestinal function (anticholinergic drugs, 5-HT3 receptor antagonists, antidiarrheal agents, antacids, prokinetic agents, antidepressants, anti-anxiety agents, intestinal bacteria, Group of regulating drugs, etc.); 8. Allergies, or those who are allergic to 3 foods, or those who are known to be allergic to the ingredients of Chang jian Capsules; 9. The subject is suspected or indeed have a history of alcohol or drug abuse; 10. Pregnant or lactating women, recent pregnancy planners; 11. The subject has Cognitive dysfunction that cannot be given adequate informed consent; 12. The subject Hepatitis B surface antigen, human immunodeficiency virus antibody, hepatitis C antibody or treponema pallidum antibody test results are positive ; 13. The subject who participated in other clinical trials in the past month; 14. The subject with known familial colorectal cancer syndrome; 15. The subject who are not suitable for inclusion in the opinion of the investigator.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Treatment response rate of diarrhea (fecal trait);Treatment response rate;Abdominal pain response rate;The change in number of diarrhea days over the past week from the baseline;The change in number of average diarrhea episodes over the past week from the baseline;The change in stool urgency score over the past two weeks from the baseline;The most severe bloating numerical rating scale (NRS) score in the past 24 hours, and the change in weekly average NRS score from the baseline;The most severe abdominal discomfort NRS score in the past 24 hours, and the change in weekly average NRS score from the baseline;The change in IBS Symptom Severity Score (IBS-SSS) from the baseline;The change in the traditional Chinese medicine (TCM) syndrome score from the baseline;Relapse rate of IBS-D;The amount of emergency drugs used; | — |
Primary
| Measure | Time frame |
|---|---|
| Treatment response rate of diarrhea (fecal trait) ; | — |
Countries
China
Contacts
Public ContactShengsheng Zhang
Beijing Chinese Medicine Hospital Affiliated to Capital Medical University
Outcome results
None listed