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

NCT05113888 | Unknown Phase 2

• 1 other identifier: CR999-QZWT-IBS-01
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Irritable Bowel Syndrome

Keywords

Qizhi Weitong granules; Irritable bowel syndrome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Frequency of abdominal pain

  Recorded daily by patients from baseline to day56

• IBS symptom severity scale（IBS-SSS）

  Baseline and days 14，28，56

• IBS Quality of Life Scale（IBS-QOL）

  Baseline and days 14，28，56

• Self-rating Anxiety Scale（SAS)

  baseline and day56

• Self-rating Depression Scale(SDS)

  baseline and day56

Study Arms (3)

Qizhi Weitong granules high-dose group

EXPERIMENTAL

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）

Qizhi Weitong granules low-dose group

EXPERIMENTAL

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）

The control group

PLACEBO COMPARATOR

interventions：Qizhi Weitong granules placebo Specification: 5.0g/bag，Does not contain effective crude drug ingredients.

Drug: Placebo

Interventions

Qizhi weitong granules(High） DRUG

take orally before meals, 1 bag each time, 3 times a day.

Qizhi Weitong granules high-dose group

Qizhi weitong granules(Low） DRUG

take orally before meals, 1 bag each time, 3 times a day.

Qizhi Weitong granules low-dose group

Placebo DRUG

take orally before meals, 1 bag each time, 3 times a day.

The control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

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

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Xudong Tang, professor

CONTACT

+86 10-62835001; txdly@sina.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study was divided into three groups: Qizhi Weitong granule high-dose group, Qizhi Weitong granule low-dose group and placebo group

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: November 9, 2021
• Study Start: December 1, 2021
• Primary Completion: August 31, 2022
• Study Completion: December 31, 2022
• Last Updated: November 9, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share