Chronic Atrophic GastritisEarly Phase 1NCT05493124
Clinical Study of Manpixiao in the Treatment of Chronic Atrophic Gastritis
A Early Phase 1 study testing Manpixiao and Active comparator in people with Chronic Atrophic Gastritis, run by Beijing University of Chinese Medicine at 3 sites in China.
Trial summary
To explore the efficacy and safety of "Manpixiao" in the treatment of Chronic Atrophic Gastritis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Atrophic Gastritis
- What is being tested?
- Manpixiao and Active comparator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jul 2021to 31 Dec 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The age is 18-75 years old, regardless of gender;
- Before treatment, the patients were diagnosed as chronic atrophic gastritis (with intestinal metaplasia and dysplasia) by gastroscopy and pathological examination, which met the criteria of the Chinese consensus on chronic gastritis (2017, Shanghai);
- Sign the informed consent form.
Who cannot join
- Patients with autoimmune gastritis (chronic atrophic gastritis type A), peptic ulcer (a1-h2), reflux esophagitis, gastric polyps, hypertrophic gastritis and other diseases;
- Patients with high-grade intraepithelial neoplasia of gastric mucosa, suspected malignant change of gastrointestinal mucosal lesions, and gastrointestinal tumors;
- Patients with malignant tumors who have undergone surgery, radiotherapy and chemotherapy in recent 5 years;
- Patients with primary diseases such as heart, brain, lung, hematopoietic system and malignant tumors, and subjects with severe diabetes;
- Patients with chronic liver and kidney dysfunction before treatment, including ALT > 1.5 times the upper limit of normal value, blood creatinine (CR) > 1.5 times the upper limit of normal value, and platelets lower than 1.5 times the lower limit of normal value;
- Disabled subjects specified by law (blind, deaf, dumb, intellectual, mental, physical disabilities);
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- The description of self symptoms is unclear or the investigation is not the author;
- Have a history of alcohol abuse;
- Allergic constitution or a history of allergy to multiple drugs (more than two or known ingredients in the drug);
- Pregnant or lactating women;
- According to the judgment of the researcher, other reasons should not be selected.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Dongfang Hospital, Beijing University of Chinese Medicine
Beijing
Xia Ding, 13611184842, dingx@bucm.edu.cn
- Recruiting
Dongzhimen Hospital, Beijing University of TCM
Beijing
Xia Ding, 13611184842, dingx@bucm.edu.cn
- Recruiting
Zaozhuang Hospital, Beijing University of Chinese Medicine
Beijing
Xia Ding, 13611184842, dingx@bucm.edu.cn
About this study
To explore the efficacy and safety of "Manpixiao" in the treatment of Chronic Atrophic Gastritis.
- Conditions
- Chronic Atrophic Gastritis
- Being tested
- Manpixiao, Active comparator
- Medical subject headings
- Gastritis, Atrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ManpixiaoDrug
A traditional Chinese medicine composition
Active comparatorDrug
Other drugs that may have therapeutic effects
| Study group | Role | What they receive |
|---|---|---|
| Manpixiao treatment group | Experimental | A traditional Chinese medicine composition (has applied for Chinese patent)，Take 17.15g daily, twice in the morning and evening, for a total of 24 weeks Receives: Drug: Manpixiao |
| Blank treatment group | No intervention | Not described |
| Active comparator | Active comparator | Including treated with Chinese patent drugs such as Weifuchun and morodan, or treated with antacids, motivational drugs, gastric mucosal protectants, vitamins, folic acid, selenium containing preparations and other drugs. Take it according to the instructions. Receives: Drug: Active comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological improvement rate of gastric mucosa
Pathological diagnosis of gastric mucosal tissue samples obtained by gastroscopy
Measured: The enrollment inspection shall be completed within one month before enrollment; The examination after treatment should be carried out within 1 month after the completion of treatment.
Secondary outcomes (2)
Gastric mucosal status under gastroscope
For the color of gastric mucosa, spots, erosion, bleeding, reduced folds, visible blood vessels and mucosal texture, 0, 1, 2 and 3 points are given according to the levels of none, I, II and III respectively, and 0 and 1 points are given according to the presence or absence of bile reflux. According to the gastroscopy report, score the patients' microscopic results before and after treatment, and take the result change as the secondary index of curative effect. A lower score means a better result.
Measured: The enrollment inspection shall be completed within one month before enrollment; The examination after treatment should be carried out within 1 month after the completion of treatment.
Score of main symptoms of stomach system
Adopt the "table of main symptoms of stomach system based on doctor's report", the specific contents are: epigastric (epigastric) pain, epigastric (epigastric) distension, epigastric (epigastric) blockage, heartburn, acid reflux, belching, anorexia, reduced appetite. Score 0, 1, 2 and 3 points for the severity of each single symptom (none, mild, moderate and severe). The total score of symptoms is the sum of the individual scores. By comparing the changes of individual symptom scores and total symptom scores between groups, lower scores mean better results.
Measured: They were evaluated on the day of enrollment and the day of the end of the treatment process
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start1 Jul 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Atrophic GastritisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Xia Ding, Beijing University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493124
- Sponsor's protocol ID
- 2021-ZXFZJJ-035
- Status last verified
- Sep 2021
- First submitted
- 29 Jul 2022
- Last updated
- 9 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Obtained by asking the first or correspondent author if necessary
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Manpixiao in the Treatment of Chronic Atrophic Gastritis
- ClinicalTrials.gov ID
- NCT05493124
- Acronym / sponsor ID
- 2021-ZXFZJJ-035
- Conditions
- Chronic Atrophic Gastritis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Beijing University of Chinese MedicineUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 9 Aug 2022 (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.
To explore the efficacy and safety of "Manpixiao" in the treatment of Chronic Atrophic Gastritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Manpixiao treatment group | Experimental | Drug: ManpixiaoA traditional Chinese medicine composition (has applied for Chinese patent)，Take 17.15g daily, twice in the morning and evening, for a total of 24 weeks |
| Blank treatment group | No intervention | – |
| Active comparator | Active comparator | Drug: Active comparatorIncluding treated with Chinese patent drugs such as Weifuchun and morodan, or treated with antacids, motivational drugs, gastric mucosal protectants, vitamins, folic acid, selenium containing preparations and other drugs. Take it according to the instructions. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The age is 18-75 years old, regardless of gender;
- Before treatment, the patients were diagnosed as chronic atrophic gastritis (with intestinal metaplasia and dysplasia) by gastroscopy and pathological examination, which met the criteria of the Chinese consensus on chronic gastritis (2017, Shanghai);
- Sign the informed consent form.
Key exclusion criteria (11 listed)
- Patients with autoimmune gastritis (chronic atrophic gastritis type A), peptic ulcer (a1-h2), reflux esophagitis, gastric polyps, hypertrophic gastritis and other diseases;
- Patients with high-grade intraepithelial neoplasia of gastric mucosa, suspected malignant change of gastrointestinal mucosal lesions, and gastrointestinal tumors;
- Patients with malignant tumors who have undergone surgery, radiotherapy and chemotherapy in recent 5 years;
- Patients with primary diseases such as heart, brain, lung, hematopoietic system and malignant tumors, and subjects with severe diabetes;
- Patients with chronic liver and kidney dysfunction before treatment, including ALT > 1.5 times the upper limit of normal value, blood creatinine (CR) > 1.5 times the upper limit of normal value, and platelets lower than 1.5 times the lower limit of normal value;
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 |
|---|---|---|
| ManpixiaoA traditional Chinese medicine composition | Drug | Manpixiao treatment group |
| Active comparatorOther drugs that may have therapeutic effects | Drug | Active comparator |
Primary outcome
Pathological improvement rate of gastric mucosa
Time frame: The enrollment inspection shall be completed within one month before enrollment; The examination after treatment should be carried out within 1 month after the completion of treatment.
Pathological diagnosis of gastric mucosal tissue samples obtained by gastroscopy
2 secondary outcomes
Gastric mucosal status under gastroscope
Time frame: The enrollment inspection shall be completed within one month before enrollment; The examination after treatment should be carried out within 1 month after the completion of treatment.
Score of main symptoms of stomach system
Time frame: They were evaluated on the day of enrollment and the day of the end of the treatment process
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Individual participant dataSharing planned: Yes. Obtained by asking the first or correspondent author if necessary
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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.
Zaozhuang Hospital, Beijing University of Chinese Medicine
Beijing, China
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Manpixiao and Active comparator in people with Chronic Atrophic Gastritis, run by Beijing University of Chinese Medicine at 3 sites 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 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological improvement rate of gastric mucosa (time frame: The enrollment inspection shall be completed within one month before enrollment; The examination after treatment should be carried out within 1 month after the completion of treatment.). 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 Aug 2022.