Functional DyspepsiaPhase 1/2NCT03149393
Clinical Study on Post Evaluation After Listing of Qizhi Weitong Granules
A Phase 1/2 study testing Qizhi Weitong Granules and Mosapride Citrate Tablets in people with Functional Dyspepsia and Traditional Chinese Medicine, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
This study is a randomized, double blind, double dummy, multicenter, parallel controlled clinical trial, the investigators objective is to evaluate the efficacy and safety of Qizhi Weitong granules in the treatment of functional dyspepsia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Functional Dyspepsia, Traditional Chinese Medicine
- What is being tested?
- Qizhi Weitong Granules and Mosapride Citrate Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2017to 31 Dec 2020
- Phase
- Phase 1/2
- 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
- Metting the diagnostic criteria of functional dyspepsia in Rome IV.
- The subjects were informed, and the subjects voluntarily signed informed consent.
- The subjects have reading ability.
Who cannot join
- Patients suffering from gastric ulcer, gastroscopy see bleeding and mucosal erosion, pathological examination showed atrophy of gastric mucosa, intestinal metaplasia or dysplasia.
- Patients with Hp infection positive.
- Patients with gastroesophageal reflux disease.
- Patients with digestive system organic lesions.
- The patient had a history of stomach or abdominal surgery.
- Patients had taken the relevant drugs in the past 2 weeks.
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- Patients suffering from severe illness affecting survival.
- Pregnant or lactating women.
- Participating in clinical trials of other drugs.
- Long term using of sedative hypnotics.
- Suspected or true alcohol, drug abuse history.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100091
Xudong Tang, MD
About this study
This study is a randomized, double blind, double dummy, multicenter, parallel controlled clinical trial, the investigators objective is to evaluate the efficacy and safety of Qizhi Weitong granules in the treatment of functional dyspepsia.
Read the detailed description
This study is a randomized, double blind, double dummy, multicenter, parallel controlled clinical trial, the investigators objective is to evaluate the efficacy and safety of Qizhi Weitong granules in the treatment of functional dyspepsia. The experiment will be carried out in 8 sub centers at the same time, and the investigators estimated that there will be 384 cases of income, including the experimental group and the control group (n = 192), and the investigators choose mosapride citrate tablets for drug control.
- Conditions
- Functional Dyspepsia, Traditional Chinese Medicine
- Being tested
- Qizhi Weitong Granules, Mosapride Citrate Tablets
- Keywords
- Functional Dyspepsia, Qizhi Weitong Granules, Traditional Chinese Medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qizhi Weitong GranulesDrug
Also called The Treatment Group
Patients in this group will take Qizhi Weitong Granules 2.5g,3 times/day,30 minutes before dinner for 8 weeks.
Mosapride Citrate TabletsDrug
Also called The Control Group
Patients in this group will take mosapride citrate tablets 5mg,3 times/day,30 minutes before dinner for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Qizhi Weitong Granules Group | Experimental | Patients in this group will take Qizhi Weitong Granules for 8 weeks. Receives: Drug: Qizhi Weitong Granules |
| Mosapride Citrate Tablets Group | Active comparator | Patients in this group will take mosapride citrate tablets for 8 weeks. Receives: Drug: Mosapride Citrate Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Main Symptom Score
The Main Symptom Score contains evaluation of postprandial fullness discomfort, early satiety, epigastric pain, epigastric burning sensation and so on.
Measured: The score will be assessed at baseline and 2 week, 4 week, 6 week.
Secondary outcomes (1)
Change of the Hamilton Anxiety Scale and the Hamilton Depression Scale
To evaluate the changes of patients' mental and psychological status
Measured: The score will be assessed at baseline and 2 week, 4 week, 6 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start1 Feb 2017
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tang X dong, PhD, Study director, Director of Xiyuan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03149393
- Sponsor's protocol ID
- Digestion-05
- Status last verified
- Feb 2020
- First submitted
- 16 Apr 2017
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Post Evaluation After Listing of Qizhi Weitong Granules
- ClinicalTrials.gov ID
- NCT03149393
- Acronym / sponsor ID
- Digestion-05
- Conditions
- Functional Dyspepsia, Traditional Chinese Medicine
- Keywords
- Functional Dyspepsia, Qizhi Weitong Granules, Traditional Chinese Medicine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 11 May 2017 (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.
This study is a randomized, double blind, double dummy, multicenter, parallel controlled clinical trial, the investigators objective is to evaluate the efficacy and safety of Qizhi Weitong granules in the treatment of functional dyspepsia.
Detailed description
This study is a randomized, double blind, double dummy, multicenter, parallel controlled clinical trial, the investigators objective is to evaluate the efficacy and safety of Qizhi Weitong granules in the treatment of functional dyspepsia. The experiment will be carried out in 8 sub centers at the same time, and the investigators estimated that there will be 384 cases of income, including the experimental group and the control group (n = 192), and the investigators choose mosapride citrate tablets for drug control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Qizhi Weitong Granules Group | Experimental | Drug: Qizhi Weitong GranulesPatients in this group will take Qizhi Weitong Granules for 8 weeks. |
| Mosapride Citrate Tablets Group | Active comparator | Drug: Mosapride Citrate TabletsPatients in this group will take mosapride citrate tablets for 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Metting the diagnostic criteria of functional dyspepsia in Rome IV.
- The subjects were informed, and the subjects voluntarily signed informed consent.
- The subjects have reading ability.
Key exclusion criteria (11 listed)
- Patients suffering from gastric ulcer, gastroscopy see bleeding and mucosal erosion, pathological examination showed atrophy of gastric mucosa, intestinal metaplasia or dysplasia.
- Patients with Hp infection positive.
- Patients with gastroesophageal reflux disease.
- Patients with digestive system organic lesions.
- The patient had a history of stomach or abdominal surgery.
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 GranulesAlso: The Treatment GroupPatients in this group will take Qizhi Weitong Granules 2.5g,3 times/day,30 minutes before dinner for 8 weeks. | Drug | Qizhi Weitong Granules Group |
| Mosapride Citrate TabletsAlso: The Control GroupPatients in this group will take mosapride citrate tablets 5mg,3 times/day,30 minutes before dinner for 8 weeks. | Drug | Mosapride Citrate Tablets Group |
Primary outcome
Change of Main Symptom Score
Time frame: The score will be assessed at baseline and 2 week, 4 week, 6 week.
The Main Symptom Score contains evaluation of postprandial fullness discomfort, early satiety, epigastric pain, epigastric burning sensation and so on.
1 secondary outcome
Change of the Hamilton Anxiety Scale and the Hamilton Depression Scale
Time frame: The score will be assessed at baseline and 2 week, 4 week, 6 week.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- 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.
Tang X dong, PhD study director
Director of Xiyuan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Qizhi Weitong Granules and Mosapride Citrate Tablets in people with Functional Dyspepsia and Traditional Chinese Medicine, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
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 3 inclusion and 11 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 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Wang F yun, PhD (13522657731 ext. 0086, wfy811@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Main Symptom Score (time frame: The score will be assessed at baseline and 2 week, 4 week, 6 week.). 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 28 Feb 2020; AzTrials last refreshed its copy on 6 Nov 2026.