Exploratory Study on Dosage of Qizhi Weitong Granules in the Treatment of Irritable Bowel Syndrome （IBS)
- Conditions
- Irritable Bowel Syndrome
- Interventions
- Drug: Qizhi weitong granules(High）Drug: Qizhi weitong granules(Low）Drug: Placebo
- Registration Number
- NCT05113888
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Qizhi Weitong granules high-dose group Qizhi weitong granules(High） 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). Qizhi Weitong granules low-dose group Qizhi weitong granules(Low） 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). The control group Placebo interventions：Qizhi Weitong granules placebo Specification: 5.0g/bag，Does not contain effective crude drug ingredients.
- Primary Outcome Measures
Name Time Method Abdominal pain intensity Recorded daily by patients from baseline to day56 the most severe abdominal pain score in the past 24 hours, with a weekly mean decrease of at least 30% from baseline;
Improvement of stool characteristics Recorded daily by patients from baseline to day56 Record daily by symptom diary card.Stools were recorded according to Bristol Stool Chart.
- Secondary Outcome Measures
Name Time Method IBS symptom severity scale（IBS-SSS） Baseline and days 14，28，56 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.
IBS Quality of Life Scale（IBS-QOL） Baseline and days 14，28，56 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.
Self-rating Anxiety Scale（SAS) baseline and day56 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.
Frequency of abdominal pain Recorded daily by patients from baseline to day56 Number of abdominal pain
Self-rating Depression Scale(SDS) baseline and day56 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.
Emergency drug use Emergence，baseline and days 14，28，56 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.