Changyanning Tablet for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

• Status: Not yet recruiting
• Trial end date: 2024-04-30
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical trial is to test the efficacy and safety of the Chinese patent medicine Changyanning Tablet in the patients with Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D). The main questions it aims to answer are:

1. Can Changyanning Tablet improve diarrhea and abdominal pain in IBS-D patients?

2. Is Changchangning Tablet safe for the treatment of IBS-D?

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mei Han

Criteria

Inclusion Criteria:

1. Meet IBS-D Rome IV diagnostic criteria;

2. Age between 18 and 65 years old (including boundary value), regardless of gender;

3. IBS symptom severity scale (IBS-SSS) scores > 175 points;

4. The weekly average score of abdominal pain in screening period is ≥ 3 points (The most severe abdominal pain in the past 24 hours every day, the pain score was 11 grades (0-10), NRS-11; Also the number of days of the stool character classification (Bristol stool scale) is type 6 or 7 ≥ 2 in a week;

5. Patients who voluntarily accept the program's plan of the project and signs the informed consent form.

Exclusion Criteria:

1. Patients with serious or unstable heart, liver, kidney, immune, endocrine system and other diseases or malignant tumors;

2. Patients are affected by factors such as intellectual disorder, mental disorder and language;

3. Patients with gastrointestinal organic diseases or with malignant tumors, such as pancreatitis, intestinal adenoma (excluding polypectomy for more than half a month), intestinal diverticulum, colon or rectal cancer, inflammatory bowel disease, intestinal tuberculosis, etc;

4. Other diseases (such as hyperthyroidism, diabetes, chronic renal insufficiency, nervous system diseases, etc.) that affect digestive tract dynamics;

5. Complicated with tuberculosis peritonitis, gallstones, cirrhosis, chronic pancreatitis and other gastrointestinal diseases;

6. Allergic constitution or allergic to the components of the studied drug;

7. Pregnant or lactating women, and women with recent fertility plans;

8. Previous abdominal or pelvic surgery, such as cholecystectomy;

9. Patients with positive fecal occult blood;

10. During the screening period, drugs that affect gastrointestinal motility and function cannot be stopped, including parasympathetic inhibitors, such as scopolamine, atropine, belladonna, etc; Muscle relaxants, such as succinylcholine; Antidiarrheal agents such as loperamide, smecta, etc; Opioid preparations, etc;

11. Those who use probiotics (except those who eat yoghurt) or antibiotics within 8 weeks before enrollment in the study;

12. IBS drugs (except polyethylene glycol and loperamide) were used within 3 months before the study;

13. Those who regularly drink alcohol within 6 months before screening, i.e., drink more than 14 units of alcohol every week (1 unit=360 mL beer or 45 mL liquor or 150 mL wine with 40% alcohol);

14. Those who have participated in or are currently participating in other clinical trials within 1 month before screening;

15. The researcher believes that there are patients who are not suitable for inclusion.