Irritable Bowel SyndromePhase 2NCT05113888
Exploratory Study on Dosage of Qizhi Weitong Granules in the Treatment of Irritable Bowel Syndrome （IBS)
A Phase 2 study testing Qizhi weitong granules(High） and Qizhi weitong granules(Low） in people with Irritable Bowel Syndrome, run by China Resources Sanjiu Medical & Pharmaceutical Co., Ltd..
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Qizhi weitong granules(High） and Qizhi weitong granules(Low）
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 31 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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
- Being tested
- Qizhi weitong granules(High）, Qizhi weitong granules(Low）, Placebo
- Keywords
- Qizhi Weitong granules, Irritable bowel syndrome
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qizhi weitong granules(High）Drug
take orally before meals, 1 bag each time, 3 times a day.
Qizhi weitong granules(Low）Drug
take orally before meals, 1 bag each time, 3 times a day.
PlaceboDrug
take orally before meals, 1 bag each time, 3 times a day.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: 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.
Measured: Recorded daily by patients from baseline to day56
Secondary outcomes (6)
Frequency of abdominal pain
Number of abdominal pain
Measured: Recorded daily by patients from baseline to day56
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.
Measured: Baseline and days 14，28，56
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.
Measured: Baseline and days 14，28，56
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.
Measured: baseline and day56
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.
Measured: baseline and day56
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.
Measured: Emergence，baseline and days 14，28，56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start1 Dec 2021 (estimated)
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113888
- Sponsor's protocol ID
- CR999-QZWT-IBS-01
- Status last verified
- Oct 2021
- First submitted
- 20 Oct 2021
- Last updated
- 9 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05113888
- Acronym / sponsor ID
- CR999-QZWT-IBS-01
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Qizhi Weitong granules, Irritable bowel syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 9 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- The study was divided into three groups: Qizhi Weitong granule high-dose group, Qizhi Weitong granule low-dose group and placebo group
| Arm | Type | Receives |
|---|---|---|
| Qizhi Weitong granules high-dose group | Experimental | Drug: 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 | Experimental | Drug: 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 comparator | Drug: Placebointerventions：Qizhi Weitong granules placebo Specification: 5.0g/bag，Does not contain effective crude drug ingredients. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qizhi weitong granules(High）take orally before meals, 1 bag each time, 3 times a day. | Drug | Qizhi Weitong granules high-dose group |
| Qizhi weitong granules(Low）take orally before meals, 1 bag each time, 3 times a day. | Drug | Qizhi Weitong granules low-dose group |
| Placebotake orally before meals, 1 bag each time, 3 times a day. | Drug | The control group |
Primary outcome
Abdominal pain intensity
Time frame: 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
Time frame: Recorded daily by patients from baseline to day56
Record daily by symptom diary card.Stools were recorded according to Bristol Stool Chart.
6 secondary outcomes
Frequency of abdominal pain
Time frame: Recorded daily by patients from baseline to day56
IBS symptom severity scale（IBS-SSS）
Time frame: Baseline and days 14，28，56
IBS Quality of Life Scale（IBS-QOL）
Time frame: Baseline and days 14，28，56
Self-rating Anxiety Scale（SAS)
Time frame: baseline and day56
Self-rating Depression Scale(SDS)
Time frame: baseline and day56
Emergency drug use
Time frame: Emergence，baseline and days 14，28，56
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Qizhi weitong granules(High） and Qizhi weitong granules(Low） in people with Irritable Bowel Syndrome, run by China Resources Sanjiu Medical & Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xudong Tang, professor (+86 10-62835001, txdly@sina.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal pain intensity (time frame: Recorded daily by patients from baseline to day56). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.