Changyanning Tablet for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D) (NCT05687435) | Clinical Trial Compass
UnknownPhase 2/3
Changyanning Tablet for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
240 participantsStarted 2023-01-30
Plain-language 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?
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Meet IBS-D Rome IV diagnostic criteria;
✓. Age between 18 and 65 years old (including boundary value), regardless of gender;
✓. 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;
What they're measuring
1
Weekly response rate of abdominal pain and diarrhea