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

Last updated: January 13, 2023
Sponsor: Mei Han
Overall Status: Active - Not Recruiting

Phase

2/3

Condition

Colic

Gastrointestinal Diseases And Disorders

Lactose Intolerance

Treatment

N/A

Clinical Study ID

NCT05687435
CYNT-2022-12
  • Ages 18-65
  • All Genders

Study 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

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 mostsevere 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 (Bristolstool scale) is type 6 or 7 ≥ 2 in a week;
  5. Patients who voluntarily accept the program's plan of the project and signs theinformed consent form.

Exclusion

Exclusion Criteria:

  1. Patients with serious or unstable heart, liver, kidney, immune, endocrine system andother diseases or malignant tumors;
  2. Patients are affected by factors such as intellectual disorder, mental disorder andlanguage;
  3. Patients with gastrointestinal organic diseases or with malignant tumors, such aspancreatitis, 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 pancreatitisand 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 functioncannot be stopped, including parasympathetic inhibitors, such as scopolamine,atropine, belladonna, etc; Muscle relaxants, such as succinylcholine; Antidiarrhealagents such as loperamide, smecta, etc; Opioid preparations, etc;
  11. Those who use probiotics (except those who eat yoghurt) or antibiotics within 8 weeksbefore enrollment in the study;
  12. IBS drugs (except polyethylene glycol and loperamide) were used within 3 months beforethe study;
  13. Those who regularly drink alcohol within 6 months before screening, i.e., drink morethan 14 units of alcohol every week (1 unit=360 mL beer or 45 mL liquor or 150 mL winewith 40% alcohol);
  14. Those who have participated in or are currently participating in other clinical trialswithin 1 month before screening;
  15. The researcher believes that there are patients who are not suitable for inclusion.

Study Design

Total Participants: 240
Study Start date:
January 30, 2023
Estimated Completion Date:
April 30, 2024