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

Changyanning Tablet for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D): A Multicenter, Randomized, Double Blind, Placebo-Controlled Trial

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Diarrhea-Predominant Irritable Bowel Syndrome
• Intervention / Treatment: Drug: Changyanning tablet; Other: Changyanning tablet placebo

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Mei Han, Dr; Phone Number: +8613401131731; Email: hanmeizoujin@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Changyanning group; 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; 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.
Placebo Comparator: Placebo group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%.	2 weeks, 4 weeks, 6 weeks, 12 weeks
Weekly response rate of diarrhea	The responder is defined when the following two points are met simultaneously： ①Fecal 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. ②Abdominal pain intensity: the most severe abdominal pain score in the past 24 hours, the weekly average value is remained unchanged or improved from 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). The response rate=(the number of the responders/the sample size of the group) x100%.	2 weeks, 4 weeks, 6 weeks, 8 weeks，12 weeks
Weekly response rate of abdominal pain	The responder is defined when the following two points are met simultaneously： ①Abdominal 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). ②Fecal traits: the number of days and frequency with type 6 or 7 stool traits in a week is remained unchanged or decreased from 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%.	2 weeks, 4 weeks, 6 weeks, 8 weeks，12 weeks
IBS symptom severity scale（IBS-SSS）scores	There are five questions in the scale, each of which has a full score of 100 points and a total score of 500 points. The higher the total score, the more serious the patient's symptoms.	2 weeks, 4 weeks, 6 weeks, 8 weeks，12 weeks
Stool frequency	Daily average number of spontaneous defecation in a week.	2 weeks, 4 weeks, 6 weeks, 8 weeks，12 weeks
IBS quality of life (IBS-QOL) scores	The scale consists of 34 items, and each item is divided into five grades: asymptomatic, mild, moderate, overweight, and severe, with corresponding scores of 1-5. The higher the total score, the more serious the patient's symptoms.	6 weeks, 8 weeks（after treatment），12 weeks（after follow-up）

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood routine test	This is a safety outcome.	baseline， 8weeks（after treatment）
C-reactive protein	This is a safety outcome.	baseline， 8weeks（after treatment）
Urine routine test	This is a safety outcome.	baseline， 8weeks（after treatment）
Stool routine test	This is a safety outcome.	baseline， 8weeks（after treatment）
Stool occult blood	This is a safety outcome.	baseline， 8weeks（after treatment）
Liver function-Alanine aminotransferase（ALT）	This is a safety outcome.	baseline， 8weeks（after treatment）
Liver function-Aspartate aminotransferase (AST)	This is a safety outcome.	baseline， 8weeks（after treatment）
Liver function-alkaline phosphatase (ALP)	This is a safety outcome.	baseline， 8weeks（after treatment）
Renal function-blood urea nitrogen (BUN)	This is a safety outcome.	baseline， 8weeks（after treatment）
Renal function-creatinine	This is a safety outcome.	baseline， 8weeks（after treatment）
Electrocardiogram	This is a safety outcome.	baseline， 8weeks（after treatment）
Adverse events	This is a safety outcome.	Up to 8 weeks
Serious adverse events	This is a safety outcome.	Up to 8 weeks

Collaborators and Investigators

• Sponsor: Mei Han
• Investigators: Principal Investigator: Wei Wei, Pro, Wangjing Hospital of China Academy of Chinese Medical Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): January 30, 2023
• Primary Completion (Anticipated): January 31, 2023
• Study Completion (Anticipated): April 30, 2024

Study Registration Dates

• First Submitted: December 23, 2022
• First Submitted That Met QC Criteria: January 13, 2023
• First Posted (Actual): January 18, 2023

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 13, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Diarrhea
• Other Study ID Numbers: CYNT-2022-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No