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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05113888
Other study ID # CR999-QZWT-IBS-01
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date December 1, 2021
Est. completion date December 31, 2022

Study information

Verified date October 2021
Source China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.
Contact Xudong Tang, professor
Phone +86 10-62835001
Email txdly@sina.com.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date December 31, 2022
Est. primary completion date August 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Qizhi weitong granules(High)
take orally before meals, 1 bag each time, 3 times a day.
Qizhi weitong granules(Low)
take orally before meals, 1 bag each time, 3 times a day.
Placebo
take orally before meals, 1 bag each time, 3 times a day.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Frequency of abdominal pain Number of abdominal pain Recorded daily by patients from baseline to day56
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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