Effectiveness and safety of Compound Glutamine Entersoluble Capsules versus placebo for diarrhea-predominant irritable bowel syndrome

Phase 2

• Conditions: Diarrhea-predominant irritable bowel syndrome; Digestive System; Irritable bowel syndrome with diarrhoea

• Registration Number: ISRCTN85973621
• Lead Sponsor: Di Ao Chengdu Pharmaceutical Co., Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-09
• Last Update Posted: 17 January 2022
• Study Completion: 2022-05-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 198

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 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)<br> 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)<br> 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)<br>