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

Diarrhea-Predominant Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05687435
• Other study ID #: CYNT-2022-12
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: January 30, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: January 2023
• Source: Beijing University of Chinese Medicine
• Contact: Mei Han, Dr
• Phone: +8613401131731
• Email: hanmeizoujin[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: April 30, 2024
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diarrhea
• Diarrhea-Predominant Irritable Bowel Syndrome
• Irritable Bowel Syndrome
• Syndrome

Intervention

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.

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mei Han

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood routine test	This is a safety outcome.	baseline, 8weeks(after treatment)
Other	C-reactive protein	This is a safety outcome.	baseline, 8weeks(after treatment)
Other	Urine routine test	This is a safety outcome.	baseline, 8weeks(after treatment)
Other	Stool routine test	This is a safety outcome.	baseline, 8weeks(after treatment)
Other	Stool occult blood	This is a safety outcome.	baseline, 8weeks(after treatment)
Other	Liver function-Alanine aminotransferase(ALT)	This is a safety outcome.	baseline, 8weeks(after treatment)
Other	Liver function-Aspartate aminotransferase (AST)	This is a safety outcome.	baseline, 8weeks(after treatment)
Other	Liver function-alkaline phosphatase (ALP)	This is a safety outcome.	baseline, 8weeks(after treatment)
Other	Renal function-blood urea nitrogen (BUN)	This is a safety outcome.	baseline, 8weeks(after treatment)
Other	Renal function-creatinine	This is a safety outcome.	baseline, 8weeks(after treatment)
Other	Electrocardiogram	This is a safety outcome.	baseline, 8weeks(after treatment)
Other	Adverse events	This is a safety outcome.	Up to 8 weeks
Other	Serious adverse events	This is a safety outcome.	Up to 8 weeks
Primary	Weekly response rate of abdominal pain and diarrhea	The responder is defined when the following two points are met simultaneously: ? 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).; ? 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	Weekly response rate of abdominal pain and diarrhea	The responder is defined when the following two points are met simultaneously: ? 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).; ? 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
Secondary	Weekly response rate of diarrhea	The responder is defined when the following two points are met simultaneously: ?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.; ?Abdominal 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
Secondary	Weekly response rate of abdominal pain	The responder is defined when the following two points are met simultaneously: ?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).; ?Fecal 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
Secondary	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
Secondary	Stool frequency	Daily average number of spontaneous defecation in a week.	2 weeks, 4 weeks, 6 weeks, 8 weeks,12 weeks
Secondary	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)