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

NCT ID: NCT05687435

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-30
• Study Completion Date: 2024-04-30

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?

Conditions

Diarrhea-Predominant Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Changyanning tablet

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

Changyanning tablet placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mei Han

OTHER

Sponsor Role: lead

Responsible Party

Mei Han

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Wei Wei, Pro

Role: PRINCIPAL_INVESTIGATOR

Wangjing Hospital of China Academy of Chinese Medical Sciences

Central Contacts

Mei Han, Dr

Role: CONTACT

hanmeizoujin@163.com

+8613401131731

Other Identifiers

CYNT-2022-12

Identifier Type: -

Identifier Source: org_study_id