Exploratory Study on Dosage of Qizhi Weitong Granules in the Treatment of Irritable Bowel Syndrome （IBS)

A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial of Qizhi Weitong Granules in the Treatment of Abdominal Pain Symptoms in Diarrhea-type Irritable Bowel Syndrome

The purpose of this study are as follows: 1) To evaluate the efficacy and safety of Qizhi Weitong granules in the treatment of diarrhea-type irritable bowel syndrome (IBS-D);2) To explore the dosage of Qizhi Weitong Granulesin treatment of IBS-D.

Study Overview

• Status: Not yet recruiting
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Drug: Qizhi weitong granules(High）; Drug: Qizhi weitong granules(Low）; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xudong Tang, professor; Phone Number: +86 10-62835001; Email: txdly@sina.com.cn

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:

• In line with the diagnostic criteria of WESTERN medicine IBS-D;
• Aged 18-65 (including 18 and 65 years old) years;
• The mean weekly NRS score for abdominal pain (the most severe in the past 24 hours) was between 3.0 and 7.0 within the last week, and there were at least 2 days per week when fecal traits were classified as type 6 or 7;
• Informed consent, voluntary test.

Exclusion Criteria:

• Stool number of type 7 according to Bristol Stool Chart, more than 3 times per day;
• TCM syndrome was diagnosed as deficiency of spleen and kidney Yang syndrome；
• Patients who took emergency medication (Piveronium bromide tablets) more than the standard during admission period (more than 2 days per week on average)；
• Patients who have been diagnosed with organic diseases of digestive system, such as inflammatory bowel disease, intestinal tuberculosis, intestinal tumor, etc., or are still complicated with peptic ulcer and infectious diarrhea；
• Patients with similar symptoms of IBS, such as eosinophilic enteritis, collagenous enteritis, lactose intolerance, etc.
• Patients with intestinal diseases of digestive system, such as tuberculous peritonitis, cirrhosis, chronic pancreatitis, etc.
• Patients with systemic diseases affecting digestive tract function, such as hyperthyroidism or hypothyroidism, endometriosis, chronic renal insufficiency, autoimmune diseases, diabetes, etc.
• Previous gastrointestinal surgery (except for appendicitis);
• Patients with serious cardiovascular diseases, serious liver and kidney diseases, hematopoietic system diseases, tumor, neurological or psychiatric system diseases;
• Major anxiety (SAS score ≥70) or major depression (SDS Score ≥73);
• Concomitant drugs affecting gastrointestinal motility and function (prokinetic drugs, anticholinergic drugs, calcium channel blockers, 5-HT3 receptor antagonists, antidiarrhea agents, antacids, antidepressants, antianxiety drugs, intestinal microbiota regulators, antibiotics, etc.) should not be discontinued in the test;
• Pregnant or lactating women who had a birth plan from enrollment to 3 months after the end of the trial.
• Allergic to the test drug emergency drug and its ingredients;
• Suspected or confirmed history of alcohol or drug abuse;
• Patients who participated in other clinical trials within 1 month prior to enrollment;
• Other subjects considered unsuitable for clinical trials by the researchers.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Qizhi Weitong granules high-dose group; interventions：Qizhi Weitong granules Specification: 5.0g/bag，the drug content is equivalent to 2 bags of Qizhi Weitong granules (2.5g/ bag commercially available).	Drug: Qizhi weitong granules(High）; take orally before meals, 1 bag each time, 3 times a day.
Experimental: Qizhi Weitong granules low-dose group; interventions：Qizhi Weitong granules Specification: 5.0g/bag，the drug content is equivalent to 1 bag of Qizhi Weitong granules (2.5g/ bag commercially available).	Drug: Qizhi weitong granules(Low）; take orally before meals, 1 bag each time, 3 times a day.
Placebo Comparator: The control group; interventions：Qizhi Weitong granules placebo Specification: 5.0g/bag，Does not contain effective crude drug ingredients.	Drug: Placebo; take orally before meals, 1 bag each time, 3 times a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abdominal pain intensity	the most severe abdominal pain score in the past 24 hours, with a weekly mean decrease of at least 30% from baseline;	Recorded daily by patients from baseline to day56
Improvement of stool characteristics	Record daily by symptom diary card.Stools were recorded according to Bristol Stool Chart.	Recorded daily by patients from baseline to day56

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of abdominal pain	Number of abdominal pain	Recorded daily by patients from baseline to day56
IBS symptom severity scale（IBS-SSS）	The IBS symptom severity questionnaire consists of four questions on a 100-point scale, with the highest score being 100 and the lowest being 0. The higher the score, the more severe the symptoms.	Baseline and days 14，28，56
IBS Quality of Life Scale（IBS-QOL）	The IBS Quality of Life scale has 34 questions, and adopts a five-level scoring system, with the highest score of 4 points and the lowest score of 0 points. The higher the score, the more serious it is.	Baseline and days 14，28，56
Self-rating Anxiety Scale（SAS)	There are 20 questions in the self-rating anxiety scale, which is graded at four levels, with the highest score being 4 and the lowest score being 1. The higher the score is, the more serious it is.	baseline and day56
Self-rating Depression Scale(SDS)	There are 20 questions in the Self-rating Depression Scale, which is graded at four levels, with the highest score being 4 and the lowest score being 1. The higher the score is, the more serious it is.	baseline and day56
Emergency drug use	Subjects may take Piaverium bromide tablets 3-4 tablets per day if they feel unbearable abdominal pain, and increase to 6 tablets per day if necessary.	Emergence，baseline and days 14，28，56

Collaborators and Investigators

• Sponsor: China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): August 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: October 29, 2021
• First Posted (Actual): November 9, 2021

Study Record Updates

• Last Update Posted (Actual): November 9, 2021
• Last Update Submitted That Met QC Criteria: October 29, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Irritable bowel syndrome; Qizhi Weitong granules
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: CR999-QZWT-IBS-01

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