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

NCT05687435 | Unknown Phase 2

• 1 other identifier: CYNT-2022-12
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

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

Conditions

Diarrhea-Predominant Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Weekly response rate of abdominal pain and diarrhea

  The responder is defined when the following two points are met simultaneously： ① Abdominal pain intensity: the most severe abdominal pain score in the past 24 hours, the weekly average value is at least 30% lower than the baseline. To evaluate the intensity of abdominal pain, the patients were asked to grade "the most severe abdominal pain in the past 24 hours" every day by using the 0-10 numerical rating scale (NRS). ② Fecal traits: the number of days with type 6 or 7 stool traits in a week decreased by at least 50% from the baseline. Refer to Bristol Stool Traits Scale for evaluation of fecal traits. The response rate=(the number of the responders/the sample size of the group) x100%.

  8 weeks (after treatment)

Secondary Outcomes (6)

• Weekly response rate of abdominal pain and diarrhea

  2 weeks, 4 weeks, 6 weeks, 12 weeks

• Weekly response rate of diarrhea

  2 weeks, 4 weeks, 6 weeks, 8 weeks，12 weeks

• Weekly response rate of abdominal pain

  2 weeks, 4 weeks, 6 weeks, 8 weeks，12 weeks

• IBS symptom severity scale（IBS-SSS）scores

  2 weeks, 4 weeks, 6 weeks, 8 weeks，12 weeks

• Stool frequency

  2 weeks, 4 weeks, 6 weeks, 8 weeks，12 weeks

Other Outcomes (13)

• Blood routine test

  baseline， 8weeks（after treatment）

• C-reactive protein

  baseline， 8weeks（after treatment）

• Urine routine test

  baseline， 8weeks（after treatment）

Study Arms (2)

Changyanning group

EXPERIMENTAL

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.

Drug: Changyanning tablet

Placebo group

PLACEBO COMPARATOR

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.

Other: Changyanning tablet placebo

Interventions

Changyanning tablet DRUG

Changyanning Tablet is produced by Jiangxi Kang'enbei Traditional Chinese Medicine Co., Ltd，composed of Euphorbia humifusa, golden ear grass, camphor tree root, Elsholtzia splendens and maple leaves. It is mainly used for the treatment of acute and chronic intestinal diseases caused by various reasons. If the symptoms of the subject become worse and unbearable during the study period, it is allowed to add Pinaverium Bromide to the patient according to the specific situation.

Changyanning group

Changyanning tablet placebo OTHER

Changyanning Tablet placebo is produced by Jiangxi Kang'enbei Traditional Chinese Medicine Co., Ltd. Changyanning Tablet placebo has the same appearance, smell, taste, specifications and packaging with Changyanning Tablet, but does not contain active pharmaceutical ingredients. If the symptoms of the subject become worse and unbearable during the study period, it is allowed to add Pinaverium Bromide to the patient according to the specific situation.

Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Mei Han: lead

Study Officials

• Wei Wei, Pro

  Wangjing Hospital of China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mei Han, Dr

CONTACT

+8613401131731; hanmeizoujin@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: January 18, 2023
• Study Start: January 30, 2023
• Primary Completion: January 31, 2023
• Study Completion: April 30, 2024
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share