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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Drug: Qizhi weitong granules(High）
* Drug: Qizhi weitong granules(Low）
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study was divided into three groups: Qizhi Weitong granule high-dose group, Qizhi Weitong granule low-dose group and placebo group
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Qizhi Weitong granules high-dose group<br>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）<br>* take orally before meals, 1 bag each time, 3 times a day.<br>|
| Experimental: Qizhi Weitong granules low-dose group<br>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）<br>* take orally before meals, 1 bag each time, 3 times a day.<br>|
| Placebo Comparator: The control group<br>interventions：Qizhi Weitong granules placebo Specification: 5.0g/bag，Does not contain effective crude drug ingredients. | Drug: Placebo<br>* take orally before meals, 1 bag each time, 3 times a day.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Qizhi Weitong granules, Irritable bowel syndrome