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Not Yet Recruiting NCT05687435

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

Conditions: Diarrhea-Predominant Irritable Bowel Syndrome

Sex: All
Ages: 18 Years – 65 Years
Phase: PHASE2, PHASE3
Enrollment: 240
Sponsor: Mei Han

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:Can Changyanning Tablet improve diarrhea and abdominal pain in IBS-D patients?Is Changchangning Tablet safe for the treatment of IBS-D?

Eligibility Criteria

Inclusion Criteria:Meet IBS-D Rome IV diagnostic criteria;Age between 18 and 65 years old (including boundary value), regardless of gender;IBS symptom severity scale (IBS-SSS) scores > 175 points;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;Patients who voluntarily accept the program's plan of the project and signs the informed consent form.Exclusion Criteria:Patients with serious or unstable heart, liver, kidney, immune, endocrine system and other diseases or malignant tumors;Patients are affected by factors such as intellectual disorder, mental disorder and language;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;Other diseases (such as hyperthyroidism, diabetes, chronic renal insufficiency, nervous system diseases, etc.) that affect digestive tract dynamics;Complicated with tuberculosis peritonitis, gallstones, cirrhosis, chronic pancreatitis and other gastrointestinal diseases;Allergic constitution or allergic to the components of the studied drug;Pregnant or lactating women, and women with recent fertility plans;Previous abdominal or pelvic surgery, such as cholecystectomy;Patients with positive fecal occult blood;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;Those who use probiotics (except those who eat yoghurt) or antibiotics within 8 weeks before enrollment in the study;IBS drugs (except polyethylene glycol and loperamide) were used within 3 months before the study;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);Those who have participated in or are currently participating in other clinical trials within 1 month before screening;The researcher believes that there are patients who are not suitable for inclusion.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05687435). StuddyBuddy aggregates publicly available trial information.