Diarrhea-type irritable bowel syndrome
Conditions
Interventions
Group 1:taking Chang-Ji-An capsule
control group:taking 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. After the introduction period (for those who are in stable condition after non-medication treatment for IBS, such as diet and lifestyle conditioning, etc.), the most severe abdominal pain score of the abdominal pain intensity in the past 24 hours, should be greater than or equal to 3 points of the weekly average (11 points pain number registration amount table, NRS-11); At the same time fecal traits should be Bristol fecal traits scale type 6 or type 7 at least 2 days per week and at least one time; 3. The subject meets the Chinese medicine syndrome standard of liver and spleen syndrome; 4. Aged 18-65 years male and female; 5. The subject voluntarily accepts the treatment and signs informed consent form, the informed consent process complies with relevant GCP regulations.
Exclusion criteria
Exclusion criteria: 1. The diarrhea is caused by infectious diarrhea, inflammatory bowel disease, parasitic infection, fecal occult blood positive, colorectal tumor, malabsorption syndrome, lactose intolerance (combined medical history), and systemic diseases; 2. Non-IBS-D and patients with other digestive systemic diseases, or abdominal pain, abdominal discomfort caused by other organic lesions; 3. 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. 4. Moderate or severe depression or anxiety, mentally ill; 5. The subject had gastrointestinal surgery before; 6. 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.); 7. Allergies, or those who are allergic to 3 foods, or those who are known to be allergic to the ingredients of Chang jian Capsules; 8. The subject is suspected or indeed have a history of alcohol or drug abuse; 9. Pregnant or lactating women, recent pregnancy planners; 10. The subject has Cognitive dysfunction that cannot be given adequate informed consent; 11. The subject who participated in other clinical trials in the past month; 12. The subject who are not suitable for inclusion in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment response rate;Abdominal pain response rate;Diarrhea (fecal trait) response rate;Abdominal pain (degree);IBS Symptom Severity Score (IBS-SSS);IBS Patient Quality of Life Questionnaire (IBS-QOL);TCM syndrome score;Recurrence rate;Vital signs (body temperature, heart rate, respiration, blood pressure);Blood routine, urine routine + urine sediment microscopy, stool routine + occult blood;Liver function (ALT, AST, ALP, GGT, TBIL, DBIL), renal function (UACR, Scr, urinary NAG enzyme) examination;Electrocardiogram (ECG) examination;Fasting blood glucose (FPG), erythrocyte sedimentation rate (ESR), glycosylated hemoglobin (HbA1c);Colonoscopy;Abdominal (hepatobiliary spleen and pancreas) ultrasound;Thyroid function (T3, T4, TSH), digestive system tumor markers (CEA, CA-199);Urine pregnancy test;Adverse reactions; | — |
Countries
China
Contacts
Public ContactShengsheng Zhang
Beijing Chinese Medicine Hospital affiliated to Capital Medical University
Outcome results
None listed