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

Primary Purpose

Diarrhea-Predominant Irritable Bowel Syndrome

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Changyanning tablet
Changyanning tablet placebo
Sponsored by
Mei Han
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diarrhea-Predominant Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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; The researcher believes that there are patients who are not suitable for inclusion.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Changyanning group

    Placebo group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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%.

    Secondary Outcome Measures

    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%.
    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%.
    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%.
    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.
    Stool frequency
    Daily average number of spontaneous defecation in a week.
    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.

    Full Information

    First Posted
    December 23, 2022
    Last Updated
    January 13, 2023
    Sponsor
    Mei Han
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05687435
    Brief Title
    Changyanning Tablet for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
    Official Title
    Changyanning Tablet for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D): A Multicenter, Randomized, Double Blind, Placebo-Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 30, 2023 (Anticipated)
    Primary Completion Date
    January 31, 2023 (Anticipated)
    Study Completion Date
    April 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Mei Han

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diarrhea-Predominant Irritable Bowel Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    240 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Changyanning group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Changyanning tablet
    Intervention Description
    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
    Other
    Intervention Name(s)
    Changyanning tablet placebo
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Weekly response rate of abdominal pain and diarrhea
    Description
    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%.
    Time Frame
    8 weeks (after treatment)
    Secondary Outcome Measure Information:
    Title
    Weekly response rate of abdominal pain and diarrhea
    Description
    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%.
    Time Frame
    2 weeks, 4 weeks, 6 weeks, 12 weeks
    Title
    Weekly response rate of diarrhea
    Description
    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%.
    Time Frame
    2 weeks, 4 weeks, 6 weeks, 8 weeks,12 weeks
    Title
    Weekly response rate of abdominal pain
    Description
    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%.
    Time Frame
    2 weeks, 4 weeks, 6 weeks, 8 weeks,12 weeks
    Title
    IBS symptom severity scale(IBS-SSS)scores
    Description
    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.
    Time Frame
    2 weeks, 4 weeks, 6 weeks, 8 weeks,12 weeks
    Title
    Stool frequency
    Description
    Daily average number of spontaneous defecation in a week.
    Time Frame
    2 weeks, 4 weeks, 6 weeks, 8 weeks,12 weeks
    Title
    IBS quality of life (IBS-QOL) scores
    Description
    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.
    Time Frame
    6 weeks, 8 weeks(after treatment),12 weeks(after follow-up)
    Other Pre-specified Outcome Measures:
    Title
    Blood routine test
    Description
    This is a safety outcome.
    Time Frame
    baseline, 8weeks(after treatment)
    Title
    C-reactive protein
    Description
    This is a safety outcome.
    Time Frame
    baseline, 8weeks(after treatment)
    Title
    Urine routine test
    Description
    This is a safety outcome.
    Time Frame
    baseline, 8weeks(after treatment)
    Title
    Stool routine test
    Description
    This is a safety outcome.
    Time Frame
    baseline, 8weeks(after treatment)
    Title
    Stool occult blood
    Description
    This is a safety outcome.
    Time Frame
    baseline, 8weeks(after treatment)
    Title
    Liver function-Alanine aminotransferase(ALT)
    Description
    This is a safety outcome.
    Time Frame
    baseline, 8weeks(after treatment)
    Title
    Liver function-Aspartate aminotransferase (AST)
    Description
    This is a safety outcome.
    Time Frame
    baseline, 8weeks(after treatment)
    Title
    Liver function-alkaline phosphatase (ALP)
    Description
    This is a safety outcome.
    Time Frame
    baseline, 8weeks(after treatment)
    Title
    Renal function-blood urea nitrogen (BUN)
    Description
    This is a safety outcome.
    Time Frame
    baseline, 8weeks(after treatment)
    Title
    Renal function-creatinine
    Description
    This is a safety outcome.
    Time Frame
    baseline, 8weeks(after treatment)
    Title
    Electrocardiogram
    Description
    This is a safety outcome.
    Time Frame
    baseline, 8weeks(after treatment)
    Title
    Adverse events
    Description
    This is a safety outcome.
    Time Frame
    Up to 8 weeks
    Title
    Serious adverse events
    Description
    This is a safety outcome.
    Time Frame
    Up to 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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; The researcher believes that there are patients who are not suitable for inclusion.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mei Han, Dr
    Phone
    +8613401131731
    Email
    hanmeizoujin@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wei Wei, Pro
    Organizational Affiliation
    Wangjing Hospital of China Academy of Chinese Medical Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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