Clinical trial NCT05687435: Changyanning Tablet for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
Official title: Changyanning Tablet for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D): A Multicenter, Randomized, Double Blind, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Diarrhea-Predominant Irritable Bowel Syndrome
Lead sponsor: Beijing University of Chinese Medicine
Sponsor class: OTHER
First posted: 2023-01-18
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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?


Eligibility 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.

Primary outcomes:
measure: Weekly response rate of abdominal pain and diarrhea
timeFrame: 8 weeks (after treatment)
Secondary outcomes:
measure: Weekly response rate of abdominal pain and diarrhea
timeFrame: 2 weeks, 4 weeks, 6 weeks, 12 weeks
measure: Weekly response rate of diarrhea
timeFrame: 2 weeks, 4 weeks, 6 weeks, 8 weeks，12 weeks
measure: Weekly response rate of abdominal pain
timeFrame: 2 weeks, 4 weeks, 6 weeks, 8 weeks，12 weeks
measure: IBS symptom severity scale（IBS-SSS）scores
timeFrame: 2 weeks, 4 weeks, 6 weeks, 8 weeks，12 weeks
measure: Stool frequency
timeFrame: 2 weeks, 4 weeks, 6 weeks, 8 weeks，12 weeks
measure: IBS quality of life (IBS-QOL) scores
timeFrame: 6 weeks, 8 weeks（after treatment），12 weeks（after follow-up）
Other outcomes:
measure: Blood routine test
timeFrame: baseline， 8weeks（after treatment）
measure: C-reactive protein
timeFrame: baseline， 8weeks（after treatment）
measure: Urine routine test
timeFrame: baseline， 8weeks（after treatment）
measure: Stool routine test
timeFrame: baseline， 8weeks（after treatment）
measure: Stool occult blood
timeFrame: baseline， 8weeks（after treatment）
measure: Liver function-Alanine aminotransferase（ALT）
timeFrame: baseline， 8weeks（after treatment）
measure: Liver function-Aspartate aminotransferase (AST)
timeFrame: baseline， 8weeks（after treatment）
measure: Liver function-alkaline phosphatase (ALP)
timeFrame: baseline， 8weeks（after treatment）
measure: Renal function-blood urea nitrogen (BUN)
timeFrame: baseline， 8weeks（after treatment）
measure: Renal function-creatinine
timeFrame: baseline， 8weeks（after treatment）
measure: Electrocardiogram
timeFrame: baseline， 8weeks（after treatment）
measure: Adverse events
timeFrame: Up to 8 weeks
measure: Serious adverse events
timeFrame: Up to 8 weeks
Locations:
Study officials:
affiliation: Wangjing Hospital of China Academy of Chinese Medical Sciences
name: Wei Wei, Pro
role: PRINCIPAL_INVESTIGATOR
References: