Clinical trial NCT05113888: Exploratory Study on Dosage of Qizhi Weitong Granules in the Treatment of Irritable Bowel Syndrome （IBS)
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Irritable Bowel Syndrome
Keywords: Qizhi Weitong granules
Irritable bowel syndrome
Lead sponsor: China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-11-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was divided into three groups: Qizhi Weitong granule high-dose group, Qizhi Weitong granule low-dose group and placebo group
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Abdominal pain intensity
timeFrame: Recorded daily by patients from baseline to day56
measure: Improvement of stool characteristics
timeFrame: Recorded daily by patients from baseline to day56
Secondary outcomes:
measure: Frequency of abdominal pain
timeFrame: Recorded daily by patients from baseline to day56
measure: IBS symptom severity scale（IBS-SSS）
timeFrame: Baseline and days 14，28，56
measure: IBS Quality of Life Scale（IBS-QOL）
timeFrame: Baseline and days 14，28，56
measure: Self-rating Anxiety Scale（SAS)
timeFrame: baseline and day56
measure: Self-rating Depression Scale(SDS)
timeFrame: baseline and day56
measure: Emergency drug use
timeFrame: Emergence，baseline and days 14，28，56
Other outcomes:
Locations:
Study officials:
References: