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

Mei Han

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Diarrhea-Predominant Irritable Bowel Syndrome

Treatments: Other: Changyanning tablet placebo; Drug: Changyanning tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT05687435

CYNT-2022-12

Details and patient eligibility

About

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?

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 2 patient groups, including a placebo group

Changyanning group

Experimental group

Description:

Changyanning tablet: Each tablet weighs 0.42g and is taken orally, 4 tablets once and 3 times a day.The course of treatment was 8 weeks.

Treatment:

Drug: Changyanning tablet

Placebo group

Placebo Comparator group

Description:

Changyanning tablet placebo: Each tablet weighs 0.42g and is taken orally, 4 tablets once and 3 times a day.The course of treatment was 8 weeks.

Treatment:

Other: Changyanning tablet placebo