Irritable Bowel Syndrome
Conditions
Interventions
High dose group:Renzhu Changle Granule 8g
Low dose group:Renzhu Changle Granule 4g+Placebo 4g
Zero dose group:Placebo 8g
Sponsors
Beijing Chinese Medicine Hospital affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The following criteria must be fully compliant to enter the lead-in period: (1) Comply with the diagnosis of Western medicine diarrhea-type irritable bowel syndrome (IBS-D); (2) TCM syndrome differentiation is a syndrome of liver stagnation and spleen deficiency; (3) Age between 18 and 65 years male and female; (4) Those who voluntarily participate in clinical trials and sign informed consent. At the end of the following standard introduction period, all must be met before entering the test: (1) TCM syndrome differentiation is a syndrome of liver stagnation and spleen deficiency; (2) The weekly average of the NRS scores of the most severe abdominal pain intensity in the lead-in period is =3 points; (3) The introduction period is at least 2 days per week, and at least 1 time of Bristol fecal traits is type 6 or type 7. Note: 1) The pain NRS score, the Numerical Rating Scal (NRS), refers to a numerical rating scale score of 11 (0-10). 2) The Bristol stool trait scale is shown in Annex 2.
Exclusion criteria
Exclusion criteria: All non-conformities must enter the lead-in period when screening the following criteria: (1) other subtypes other than IBS-D; (2) Those with a history of gastrointestinal surgery (excluding cesarean section, appendectomy, and intestinal polypectomy); those with gastrointestinal organic lesions, such as gastric ulcers, intestinal polyps (polyps >0.5cm, etc.), Intestinal tuberculosis, history of colon or rectal cancer, history of inflammatory bowel disease (intestinal stenosis), and diseases that are easily confused with IBS symptoms such as eosinophilic enteritis and collagen enteritis; (3) Those with systemic diseases affecting digestive tract motility, such as diabetes, hyperthyroidism or history of hypothyroidism, chronic renal insufficiency, neuropsychiatric disorders (such as severe depression, severe anxiety); (4) Drugs that may affect or affect the function of the gastrointestinal tract (anticholinergic drugs, calcium channel blockers, 5-HT3 receptor antagonists, antidiarrheal agents, antacids, prokinetic agents, antibiotics) Depressive drugs, anti-anxiety drugs, intestinal flora regulating drugs, etc.); (5) Other drugs used for treating irritable bowel syndrome were used within 1 week before screening; (6) Liver function ALT, AST exceeds the upper limit of the reference value by 1.5 times, or Scr exceeds the upper limit of the reference value; (7) Combined with severe primary diseases such as liver, kidney, hematopoietic system, endocrine system and mental illness; (8) allergies and allergies to known components of the study drug; (9) Pregnancy, male or female with recent family planning, lactating women; (10) suspected or indeed have a history of alcohol or drug abuse; (11) Those who have participated in other clinical trials within one month; (12) According to the investigator's judgment, it is not appropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Abdominal pain intensity response rate;Fecal trait response rate;Changes in the VAS score of bowel movement urgency and abdominal distension compared with baseline;Severity score (IBS-SSS) changes from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in overall symptom scores from baseline;Changes in irritable bowel syndrome quality of life (IBS-QOL) scores compared to baseline;TCM syndrome score;Emergency drug use; | — |
Countries
China
Contacts
Public ContactShengsheng Zhang
Beijing Chinese Medicine Hospital affiliated to Capital Medical University
Outcome results
None listed