Diarrhea-predominant irritable bowel syndrome Digestive System Irritable bowel syndrome with diarrhoea
Conditions
Interventions
In this study, the researchers will allocate randomly participants into two groups using SAS software to generate a sequence of random numbers. One group receives Compound Glutamine Entersoluble Capsu
Sponsors
Di Ao Chengdu Pharmaceutical Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years, male or female 2. Those who meet IBS-D Rome IV diagnostic criteria 3. Those who meet any one type syndrome of the diagnostic criteria for TCM syndromes, including: Liver Depression and Spleen Deficiency Syndrome, Spleen Deficiency and Wetness Sheng Syndrome, Spleen and Kidney Yang Deficiency Syndrome, Spleen and Stomach Damp-Heat Syndrome, Cold and Heat Miscellaneous Syndrome 4. IBS-SSS score = 75 5. The patient did not take any drugs related to the treatment of the disease at least one week before entering the study, and did not participate in other ongoing studies 6. Patients who had a colonoscopy at a 3A (Tertiary) hospital within one year and had an examination report 7. Accept the trial voluntarily and sign the informed consent form. The informed consent process complies with Good Clinical Practice (GCP) 8. Long term residence in the place where the treatment is given
Exclusion criteria
Exclusion criteria: 1. Irritable bowel syndrome with predominant irregular bowel habits 2. Patients with tumors or organic lesions in the heart, liver, kidney, etc 3. Patients with mental illness 4. Patients with tumors or organic lesions in gastrointestinal tract, such as pancreatitis, intestinal polyps (excluding those with polypectomy for more than half a month), intestinal diverticulum, history of colon or rectal cancer, history of inflammatory bowel disease, intestinal tuberculosis, etc 5. Patients with metabolic diseases that affect the dynamics of the digestive tract, such as thyroid disease, diabetes, etc 6. Those who with allergic constitution or allergic to the composition of the studied drug 7. Patients with a history of abdominal or pelvic surgery, such as cholecystectomy 8. According to the investigator's judgment, the patient has a situation that reduces the likelihood of enrollment or complicates enrollment, such as frequent changes in the work environment and other situations that are prone to loss of follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The degree of IBS symptom severity, measured using the scale of irritable bowel syndromes symptom severity score (IBS-SSS) at baseline, 2 weeks ± 3 days (duration of treatment), 4 weeks ± 3 days (end of treatment), 8 weeks ± 3 days (end of follow-up) 2. Stool frequency: the average daily number of voluntary defecations in the week before each timepoint at baseline, 2 weeks ± 3 days (duration of treatment), 4 weeks ± 3 days (end of treatment), 8 weeks ± 3 days (end of follow-up) 3. Stool consistency measured using the Bristol stool scale at baseline, 2 weeks ± 3 days (duration of treatment), 4 weeks ± 3 days (end of treatment), 8 weeks ± 3 days (end of follow-up) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life measured using the scale of IBS-quality of life (IBS-QOL) at baseline, 4 weeks ± 3 days (end of treatment) 2. Anxiety of patient measured using the self-rating anxiety scale (SAS) at baseline, 4 weeks ± 3 days (end of treatment) 3. Depression of patient measured using the self-rating depression scale (SDS) at baseline, 4 weeks ± 3 days (end of treatment) 4. Safety assessed by: 4.1. Routine examination (blood routine, urine routine, stool routine + OB) at baseline, 4 weeks ± 3 days (end of treatment) 4.2. Biochemical indexes including liver function (ALT, AST), kidney function (BUN, Cr) measured at baseline, 4 weeks ± 3 days (end of treatment) 4.3. Electrocardiogram measured at baseline, 4 weeks ± 3 days (end of treatment) 4.4. Adverse reactions, such as rash, constipation, or other special symptoms, recorded at any time during the treatment by the patient: Incidence of adverse reactions = (number of adverse reactions / total cases) × 100% 4.5. Adverse events, such as loss of function or disability, life-threatening or even death, recorded at any time during the treatment by the researchers: incidence of adverse events = (number of adverse events / total cases) × 100% | — |
Countries
China
Contacts
Public ContactWei Wei
Outcome results
None listed