Chronic Atrophic Gastritis With Hyperplasia (Diagnosis)Early Phase 1NCT03814629
Clinical Study of Weifuchun Treatment on Precancerous Lesions of Gastric Cancer
A Early Phase 1 study testing Weifuchun in people with Chronic Atrophic Gastritis With Hyperplasia (Diagnosis), run by ShuGuang Hospital.
Trial summary
Research purpose To elucidate the effect mechanism and clinical effective of weifuchun in the prevention and treatment of chronic atrophic gastritis and precancerous lesions of gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Atrophic Gastritis With Hyperplasia (Diagnosis)
- What is being tested?
- Weifuchun
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2015to 30 Sep 2019
- Phase
- Early Phase 1
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with chronic atrophic gastritis and precancerous lesions according to the pathological findings under gastroscope
- Helicobacter pylori(-)
Who cannot join
- Patients with Helicobacter pylori positive infection without radical treatment.
- Patients with peptic ulcer, severe dysplasia or suspected malignant transformation.
- Pregnant or lactating women and those who are pregnant and may not have effective contraception.
- Patients with severe heart, lung, gallbladder, kidney, endocrine, hematopoietic system and neuropsychiatric diseases should not be included in this study.
- Allergic constitution or known ingredients of this medicine.
- Patients with other tumors.
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- Patients participating in other clinical trials within 1 month.
- Patients with severe cirrhotic ascites and portal hypertension.
- Other diseases that interfered with the study were deemed unsuitable for the patients included in the study.
About this study
Official title: Randomized Clinical Trial: Weifuchun Treatment on Precancerous Lesions of Gastric Cancer
Research purpose To elucidate the effect mechanism and clinical effective of weifuchun in the prevention and treatment of chronic atrophic gastritis and precancerous lesions of gastric cancer. From genes related to cell differentiation, proliferation, apoptosis, tumor invasion and metastasis, genes related to immune inflammation and immune escape and other possible aspects to elucidate the effective and mechanism of weifuchun's treatment on chronic atrophic gastritis, reversing precancerous lesions of gastric cancer.
Read the detailed description
Clinical research abstract Title of Research Study：Randomized clinical trial: Weifuchun Treatment and mechanism on Precancerous Lesions of Gastric Cancer.
Main Responsibility Person: Mingyu Sun research center：Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine Trial Objective：Observe the clinical efficacy and mechanism of Weifuchun in the treatment of chronic atrophic gastritis (CAG) and precancerous lesions of gastric cancer (PLGC) Therapeutic Schedule：Select 60 cases of chronic atrophic gastritis with intestinal metaplasia or dysplasia from and 60 cases of chronic atrophic gastritis without intestinal metaplasia or dysplasia at the Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine. The treatment group was given Weifuchun tablets, 4 tablets each time, 3 times a day, and 1 hour after meals. The control group was given vitamin tablets (0.2 g), 4 tablets each time, 3 times a day, and 1 hour after a meal. The course of chronic atrophic gastritis with intestinal metaplasia or dysplasia group treatment is 24 weeks, the course of chronic atrophic gastritis without intestinal metaplasia or dysplasia is 12 weeks. The all patients'clinical symptoms, histopathology, gastroscopy, and physical and chemical examinations were compared between the two groups before and after treatment.
- Being tested
- Weifuchun
- Keywords
- chronic atrophic gastritis, precancerous lesions of gastric cancer, Weifuchun, randomized clinical trial, mechanism
- Medical subject headings
- Disease, Gastritis, Atrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WeifuchunDrug
Also called vitamin
The treatment group（Weifuchun group）was given Weifuchun tablets, 4 tablets each time, 3 times a day, and 1 hour after meals. The control group(vitamin group) was given vitamin tablets (0.2 g), 4 tablets each time, 3 times a day, and 1 hour after a meal.
| Study group | Role | What they receive |
|---|---|---|
| precancerous lesions of gastric cancer | Other | 120 cases of chronic atrophic gastritis with intestinal metaplasia or dysplasia,It was randomly divided into 60 cases of treatment group and 60 cases of control group,treatment group was given Weifuchun tablets,The control group was given vitamin tablets. Receives: Drug: Weifuchun |
What is being measured
The primary outcome is the main question the study is designed to answer.
histopathology is assessing a change
The all patients' histopathology will be evaluated two times, the first time is when the patients' are included into the clinical trials, the second time is after 24 weeks treatment in each group, patients' histopathology should be evaluated for comparison between two groups,at the same time patients' histopathology should be evaluated for comparison in each group.We use Total score of gastric mucosa pathology to assess the therapeutic effect,the patients' were included into the clinical trials and after 24 weeks treatment we through the Pathological classification of chronic atrophic gastritis work out Total score of gastric mucosa pathology.
As follows:
There are five pathology grade:Chronic inflammation,Active,Atrophy,intestinal metaplasia,dysplasia.
Score 0 is normal;1 is mild; 2 is moderate;3 is severe;cumulative highest score is 15, cumulative lowest score is 0.The higher summed score, the more severe the pathological changes.
Measured: the patients' were included into the clinical trials and after 24 weeks treatment.
gastroscopy is assessing a change
The all patients' gastroscopy gastric mucosa manifestations evaluation will be evaluated two times, the first time is when the patients' are included into the clinical trials, the second time is after 24 weeks treatment in each group, patients' gastroscopy gastric mucosa manifestations should be evaluated for comparison between two groups, at the same time patients' gastroscopy should be evaluated for comparison in each group.
We use Gastric mucosa classification under gastroscope of chronic atrophic gastritis to assess the therapeutic effect,work out gastroscopy gastric mucosa manifestations integral.
There are four Gastric mucosa classification under gastroscope of chronic atrophic gastritis: erythema,erosion,Intramucosal hemorrhage,bile regurgitation.Score 0 is normal;1 is mild; 2 is moderate;3 is severe;cumulative highest score is 12, cumulative lowest score is 0.The higher summed score, the more severe the pathological changes.
Measured: the patients' were included into the clinical trials and after 24 weeks treatment.
Clinical symptom score is assessing a change
The all patients Clinical symptom assessment score when the patients' were included into the clinical trials and after 24 weeks treatment in each group. We use Clinical Symptom checklist to assess the therapeutic effect,work out Clinical Symptom integral. Clinical symptom mainly includes stomachache, acid reflux, burping, easy to hungry. Score 0 is frequency never;1 is occasionally; 2 is sometimes;3 is often; 4 is always. Summed highest score is 16, summed lowest score is 0.The higher summed score, the more severe the Clinical symptom.
Measured: the patients' were included into the clinical trials and after 24 weeks treatment.
Secondary outcomes (3)
blood routine examination
The all patients ' blood routine examination(WBC,Hb,PLT) evaluation when the patients' were included into the clinical trials and after 24 weeks treatment in each group, this is for Clinical trial safety assessment.To assess the rate of abnormal blood routine examination(WBC,Hb,PLT) in each group.
Measured: the patients' were included into the clinical trials and after 24 weeks treatment
liver function test
The all patients ' liver function test(ALT,Aspartate aminotransferase ,ALP) evaluation when the patients' were included into the clinical trials and after 24 weeks treatment in each group, this is for Clinical trial safety assessment.To assess the rate of abnormal liver function test(ALT,Aspartate aminotransferase ,ALP) in each group.
Measured: the patients' were included into the clinical trials and after 24 weeks treatment
kidney function test
The all patients ' kidney function test(Cr,BUN) evaluation when the patients' were included into the clinical trials and after 24 weeks treatment in each group, this is for Clinical trial safety assessment.To assess the rate of abnormal kidney function test(Cr,BUN) in each group.
Measured: the patients' were included into the clinical trials and after 24 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start1 Aug 2015
- Primary completion30 Sep 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Atrophic Gastritis With Hyperplasia (Diagnosis)Studies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ShuGuang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mingyu Sun, ShuGuang Hospital
- Investigators
- Mingyu Sun, doctor, Principal investigator, Ethics Committee of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03814629
- Sponsor's protocol ID
- 42507214-9
- Status last verified
- Jan 2019
- First submitted
- 30 Aug 2018
- Last updated
- 24 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bian Y, Chen X, Cao H, Xie D, Zhu M, Yuan N, Lu L, Lu B, Wu C, Bahaji Azami NL, Wang Z, Wang H, Zhang Y, Li K, Ye G, Sun M. A correlational study of Weifuchun and its clinical effect on intestinal flora in precancerous lesions of gastric cancer. Chin Med. 2021 Nov 20;16(1):120. doi: 10.1186/s13020-021-00529-9.
PubMed 34801051
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial: Weifuchun Treatment on Precancerous Lesions of Gastric Cancer
- ClinicalTrials.gov ID
- NCT03814629
- Acronym / sponsor ID
- 42507214-9
- Keywords
- chronic atrophic gastritis, precancerous lesions of gastric cancer, Weifuchun, randomized clinical trial, mechanism
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- ShuGuang HospitalUniversity, hospital or other
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 24 Jan 2019 (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.
Research purpose To elucidate the effect mechanism and clinical effective of weifuchun in the prevention and treatment of chronic atrophic gastritis and precancerous lesions of gastric cancer. From genes related to cell differentiation, proliferation, apoptosis, tumor invasion and metastasis, genes related to immune inflammation and immune escape and other possible aspects to elucidate the effective and mechanism of weifuchun's treatment on chronic atrophic gastritis, reversing precancerous lesions of gastric cancer.
Detailed description
Clinical research abstract Title of Research Study：Randomized clinical trial: Weifuchun Treatment and mechanism on Precancerous Lesions of Gastric Cancer.
Main Responsibility Person: Mingyu Sun research center：Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine Trial Objective：Observe the clinical efficacy and mechanism of Weifuchun in the treatment of chronic atrophic gastritis (CAG) and precancerous lesions of gastric cancer (PLGC) Therapeutic Schedule：Select 60 cases of chronic atrophic gastritis with intestinal metaplasia or dysplasia from and 60 cases of chronic atrophic gastritis without intestinal metaplasia or dysplasia at the Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine. The treatment group was given Weifuchun tablets, 4 tablets each time, 3 times a day, and 1 hour after meals. The control group was given vitamin tablets (0.2 g), 4 tablets each time, 3 times a day, and 1 hour after a meal. The course of chronic atrophic gastritis with intestinal metaplasia or dysplasia group treatment is 24 weeks, the course of chronic atrophic gastritis without intestinal metaplasia or dysplasia is 12 weeks. The all patients'clinical symptoms, histopathology, gastroscopy, and physical and chemical examinations were compared between the two groups before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| precancerous lesions of gastric cancer | Other | Drug: Weifuchun120 cases of chronic atrophic gastritis with intestinal metaplasia or dysplasia,It was randomly divided into 60 cases of treatment group and 60 cases of control group,treatment group was given Weifuchun tablets,The control group was given vitamin tablets. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with chronic atrophic gastritis and precancerous lesions according to the pathological findings under gastroscope
- Helicobacter pylori(-)
Key exclusion criteria (9 listed)
- Patients with Helicobacter pylori positive infection without radical treatment.
- Patients with peptic ulcer, severe dysplasia or suspected malignant transformation.
- Pregnant or lactating women and those who are pregnant and may not have effective contraception.
- Patients with severe heart, lung, gallbladder, kidney, endocrine, hematopoietic system and neuropsychiatric diseases should not be included in this study.
- Allergic constitution or known ingredients of this medicine.
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 |
|---|---|---|
| WeifuchunAlso: vitaminThe treatment group（Weifuchun group）was given Weifuchun tablets, 4 tablets each time, 3 times a day, and 1 hour after meals. The control group(vitamin group) was given vitamin tablets (0.2 g), 4 tablets each time, 3 times a day, and 1 hour after a meal. | Drug | precancerous lesions of gastric cancer |
Primary outcome
histopathology is assessing a change
Time frame: the patients' were included into the clinical trials and after 24 weeks treatment.
The all patients' histopathology will be evaluated two times, the first time is when the patients' are included into the clinical trials, the second time is after 24 weeks treatment in each group, patients' histopathology should be evaluated for comparison between two groups,at the same time patients' histopathology should be evaluated for comparison in each group.We use Total score of gastric mucosa pathology to assess the therapeutic effect,the patients' were included into the clinical trials and after 24 weeks treatment we through the Pathological classification of chronic atrophic gastritis work out Total score of gastric mucosa pathology. As follows: There are five pathology grade:Chronic inflammation,Active,Atrophy,intestinal metaplasia,dysplasia. Score 0 is normal;1 is mild; 2 is moderate;3 is severe;cumulative highest score is 15, cumulative lowest score is 0.The higher summed score, the more severe the pathological changes.
gastroscopy is assessing a change
Time frame: the patients' were included into the clinical trials and after 24 weeks treatment.
The all patients' gastroscopy gastric mucosa manifestations evaluation will be evaluated two times, the first time is when the patients' are included into the clinical trials, the second time is after 24 weeks treatment in each group, patients' gastroscopy gastric mucosa manifestations should be evaluated for comparison between two groups, at the same time patients' gastroscopy should be evaluated for comparison in each group. We use Gastric mucosa classification under gastroscope of chronic atrophic gastritis to assess the therapeutic effect,work out gastroscopy gastric mucosa manifestations integral. There are four Gastric mucosa classification under gastroscope of chronic atrophic gastritis: erythema,erosion,Intramucosal hemorrhage,bile regurgitation.Score 0 is normal;1 is mild; 2 is moderate;3 is severe;cumulative highest score is 12, cumulative lowest score is 0.The higher summed score, the more severe the pathological changes.
Clinical symptom score is assessing a change
Time frame: the patients' were included into the clinical trials and after 24 weeks treatment.
The all patients Clinical symptom assessment score when the patients' were included into the clinical trials and after 24 weeks treatment in each group. We use Clinical Symptom checklist to assess the therapeutic effect,work out Clinical Symptom integral. Clinical symptom mainly includes stomachache, acid reflux, burping, easy to hungry. Score 0 is frequency never;1 is occasionally; 2 is sometimes;3 is often; 4 is always. Summed highest score is 16, summed lowest score is 0.The higher summed score, the more severe the Clinical symptom.
3 secondary outcomes
blood routine examination
Time frame: the patients' were included into the clinical trials and after 24 weeks treatment
liver function test
Time frame: the patients' were included into the clinical trials and after 24 weeks treatment
kidney function test
Time frame: the patients' were included into the clinical trials and after 24 weeks treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2019.
- Derived from this study: PubMed 34801051Bian Y, Chen X, Cao H, Xie D, Zhu M, Yuan N, Lu L, Lu B, Wu C, Bahaji Azami NL, Wang Z, Wang H, Zhang Y, Li K, Ye G, Sun M. A correlational study of Weifuchun and its clinical effect on intestinal flora in precancerous lesions of gastric cancer. Chin Med. 2021 Nov 20;16(1):120. doi: 10.1186/s13020-021-00529-9.
- Individual participant dataSharing planned: Undecided
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Chronic Atrophic Gastritis With Hyperplasia (Diagnosis)
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.
Mingyu Sun, doctor principal investigator
Ethics Committee of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Weifuchun in people with Chronic Atrophic Gastritis With Hyperplasia (Diagnosis), run by ShuGuang Hospital.
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 2 inclusion and 9 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 24 Jan 2019. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
histopathology is assessing a change (time frame: the patients' were included into the clinical trials and after 24 weeks treatment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03814629, which also lists 1 linked publication.
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 24 Jan 2019.