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

Primary Purpose

Irritable Bowel Syndrome

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Qizhi weitong granules(High）

Qizhi weitong granules(Low）

Placebo

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Qizhi Weitong granules, Irritable bowel syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Qizhi Weitong granules high-dose group

Qizhi Weitong granules low-dose group

The control group

Arm Description

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).

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).

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

Outcomes

Primary Outcome Measures

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;

Improvement of stool characteristics

Record daily by symptom diary card.Stools were recorded according to Bristol Stool Chart.

Secondary Outcome Measures

Frequency of abdominal pain

Number of abdominal pain

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT05113888

First Posted

October 20, 2021

Last Updated

October 29, 2021

Sponsor

China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05113888

Brief Title

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

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

December 1, 2021 (Anticipated)

Primary Completion Date

August 31, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irritable Bowel Syndrome

Keywords

Qizhi Weitong granules, Irritable bowel syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

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

ParticipantInvestigator

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Qizhi Weitong granules high-dose group

Arm Type

Experimental

Arm Description

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).

Arm Title

Qizhi Weitong granules low-dose group

Arm Type

Experimental

Arm Description

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).

Arm Title

The control group

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Qizhi weitong granules(High）

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Qizhi weitong granules(Low）

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Abdominal pain intensity

Description

the most severe abdominal pain score in the past 24 hours, with a weekly mean decrease of at least 30% from baseline;

Time Frame

Recorded daily by patients from baseline to day56

Title

Improvement of stool characteristics

Description

Record daily by symptom diary card.Stools were recorded according to Bristol Stool Chart.

Time Frame

Recorded daily by patients from baseline to day56

Secondary Outcome Measure Information:

Title

Frequency of abdominal pain

Description

Number of abdominal pain

Time Frame

Recorded daily by patients from baseline to day56

Title

IBS symptom severity scale（IBS-SSS）

Description

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.

Time Frame

Baseline and days 14，28，56

Title

IBS Quality of Life Scale（IBS-QOL）

Description

Time Frame

Baseline and days 14，28，56

Title

Self-rating Anxiety Scale（SAS)

Description

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.

Time Frame

baseline and day56

Title

Self-rating Depression Scale(SDS)

Description

Time Frame

baseline and day56

Title

Emergency drug use

Description

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.

Time Frame

Emergence，baseline and days 14，28，56

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xudong Tang, professor

Phone

+86 10-62835001

txdly@sina.com.cn

12. IPD Sharing Statement

Plan to Share IPD

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

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