Diarrhea-predominant irritable bowel syndrome Digestive System Irritable bowel syndrome with diarrhoea
Conditions
Interventions
Current intervention as of 05/07/2021:
Participants are randomized into two groups using SAS software to generate a sequence of random numbers. One group receives Tongxie Yaofang, and the control grou
Sponsors
National Natural Science Foundation of China
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 05/07/2021: 1. Aged 18 to 65 years, male or female 2. Those who meet IBS-D Rome IV diagnostic criteria 3. Those who meet Liver Depression and Spleen Deficiency Syndrome (Ganyu Pixu Zheng) from the diagnostic criteria for TCM syndromes 4. IBS-SSS score =75 5. The patient did not take any drugs related to the treatment of the disease at least 1 week before entering the study and did not participate in other ongoing studies 6. Patients who have had a colonoscopy within 1 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 _____ Previous inclusion criteria: 1. Aged 18 to 65 years, male or female 2. Those who meet IBS-D Rome IV diagnostic criteria 3. Those who meet Liver Depression and Spleen Deficiency Syndrome (Ganyu Pixu Zheng) from the diagnostic criteria for TCM syndromes 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 1 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: Current exclusion criteria as of 05/07/2021: 1. Irritable bowel syndrome with predominant irregular bowel habits 2. Patients with severe tumors or organic lesions in the heart, liver, or kidney 3. Patients with severe mental illness or language disorders that affect communication 4. Patients with severe tumors or organic lesions in gastrointestinal tract, such as pancreatitis, history of colon or rectal cancer, intestinal tuberculosis, ulcerative colitis or Crohn's disease 5. Patients with metabolic diseases affecting gastrointestinal motility, such as hyperthyroidism 6. Those who with an allergic constitution or allergic to the composition of the studied medication 7. Patients with a history of gastrointestinal surgery 8. Pregnant or lactating women, and women planning to have a child or fertility treatment _____ Previous 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, e.g., 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. In light of the investigator's judgment, the patient has a situation that reduces the likelihood of enrollment or complicates enrollment, e.g., frequent changes in the work environment and other situations that are prone to loss of follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 02/03/2022: 1. The degree of IBS symptom severity, measured using the scale of irritable bowel syndromes symptom severity score (IBS-SSS) at baseline, 4 weeks ± 3 days (duration of treatment), 8 weeks ± 3 days (end of treatment), 3 months ± 3 days (end of follow-up) Previous primary outcome measure: 1. The degree of IBS symptom severity, measured using the scale of irritable bowel syndromes symptom severity score (IBS-SSS) at baseline, 4 weeks ± 3 days (duration of treatment), 8 weeks ± 3 days (end of treatment), 3 months ± 3 days (end of follow-up) 2. Stool frequency: the average daily number of voluntary defecations recorded in the week before each timepoint at baseline, 4 weeks ± 3 days (duration of treatment), 8 weeks ± 3 days (end of treatment), 3 months ± 3 days (end of follow-up) 3. Stool consistency measured using the Bristol stool scale at baseline, 4 weeks ± 3 days (duration of treatment), 8 weeks ± 3 days (end of treatment), 3 months ± 3 days (end of follow-up) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 02/03/2022: 1. Stool frequency: the average daily number of voluntary defecations recorded in the week before each timepoint at baseline, 4 weeks ± 3 days (duration of treatment), 8 weeks ± 3 days (end of treatment), 3 months ± 3 days (end of follow-up) 2. Stool consistency measured using the Bristol stool scale at baseline, 4 weeks ± 3 days (duration of treatment), 8 weeks ± 3 days (end of treatment), 3 months ± 3 days (end of follow-up) 3. Quality of life measured using the scale of IBS-quality of life (IBS-QOL) at baseline, 8 weeks ± 3 days (end of treatment) 4. Anxiety measured using the self-rating anxiety scale (SAS) at baseline, 8 weeks ± 3 days (end of treatment) 5. Depression measured using the self-rating depression scale (SDS) at baseline, 8 weeks ± 3 days (end of treatment) 6. Safety assessed by: 4.1. Routine examination (blood routine, urine routine, stool routine + occult blood (OB)) at baseline, 8 weeks ± 3 days (end of treatment) 6.2. Biochemical indexes including liver function (aspartate aminotransferase (AST) and alanine aminotransferase (ALT)), kidney function (blood urea nitrogen (BUN), creatinine) measured at baseline, 8 weeks ± 3 days (end of treatment) 6.3. Heart electrical activity measured using electrocardiogram at baseline, 8 weeks ± 3 days (end of treatment) 6.4. Adverse events, such as rash, constipation, or other special symptoms, recorded at any time during the treatment by the patient: Incidence of adverse events = (number of adverse events / total cases) × 100% 6.5. Severe 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 severe adverse events = (number of severe adverse events / total cases) × 100% Previous secondary outcome measures: 1. Quality of life measured using the scale of IBS-quality of life (IBS-QOL) at baseline, 8 weeks ± 3 days (end of treatment) 2. Anxiety measured u | — |
Countries
China
Contacts
Public ContactHong-Jie Cheng
Outcome results
None listed