Chronic Atrophic GastritisNCT05388890
Treatment of Atrophic Gastritis After HP Eradication With Modified Liujunzi Decoction Based on Syndrome Differentiation
An observational study of Chronic Atrophic Gastritis, run by Peking University First Hospital at 1 site in China.
Trial summary
This is an observational cohort study of clinical efficacy study.The purpose of this topic is to evaluate the efficacy and safety of Modified Liujunzi Decoction based on syndrome differentiation in patients with chronic atrophic gastritis(CAG) after HP eradication.Taking Modified Liujunzi Decoction as the observation… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Atrophic Gastritis
- What is being tested?
- MLD and WFC
- How many people
- 286 participants
- Where
- 1 siteChina
- Study dates
- 2 Aug 2022to 31 Dec 2025
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: According to the willingness of the patients, the CAG patients after HP eradication in the routine diagnosis and treatment of the Department of integrated traditional Chinese and Western medicine and the Department of Gastroenterology of the Peking University First Hospital were enrolled.
Who may be able to join
- Patients with CAG diagnosed by endoscopy and pathological examination, the pathological diagnosis criteria refer to the China consensus of chronic gastritis (2017) ;
- Previous HP infection, HP negative after standardized treatment;
- TCM syndrome differentiation mainly focuses on the weakness of the spleen and stomach,referring to the consensus on the diagnosis and treatment of chronic atrophic gastritis with integrated traditional Chinese and Western Medicine (2017), there is no restriction on concurrent syndrome;
- Age 18-70 years old, regardless of gender;
- The subject (or legal representative) voluntarily agreed and signed the informed consent form, and was able to abide by the study protocol during the study.
Who cannot join
- History of gastric surgery;
- Combined with serious diseases affecting the study evaluation, such as serious liver disease, heart disease, kidney disease, malignant tumor and alcoholism;
- Allergic to the drugs used in this study;
- Participated in clinical research of other drugs in the first 3 months of the study;
- Patients can't express correctly their subjective feelings and can't cooperate.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Qiuyue Huang, doctor, +86010 83572351 ext. 803, 1711210349@pku.edu.cn
About this study
Official title: Clinical Study on the Efficacy of Modified Liujunzi Prescription on the Treatment of Atrophic Gastritis After HP Eradication
This is an observational cohort study of clinical efficacy study.The purpose of this topic is to evaluate the efficacy and safety of Modified Liujunzi Decoction based on syndrome differentiation in patients with chronic atrophic gastritis(CAG) after HP eradication.Taking Modified Liujunzi Decoction as the observation group and Weifuchun routine treatment as the control group, so as to provide evidence for the treatment of CAG and reduce the risk of gastric cancer. A total of 284 patients were included. The curative efficacy, symptom score and adverse events will be recorded and analyzed.
- Conditions
- Chronic Atrophic Gastritis
- Being tested
- MLD, WFC
- Keywords
- Chronic Atrophic Gastritis, Modified Liujunzi Decoction, Treatment Based on Syndrome Differentiation, Clinical Study, Efficacy, Cohort Study
- Medical subject headings
- Gastritis, Atrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MLDDrug
Modified Liujunzi Decoction is provided by the chinese pharmacy of Peking University First Hospital , one dose per day, taken in twice, and the course of treatment is 6 months.
WFCDrug
Chinese patent medicine, take according to the instructions, the course of treatment is 6 months.
| Study group | Role | What they receive |
|---|---|---|
| MLD | Modified Liujunzi Decoction,1 package twice daily,6 months Receives: Drug: MLD | |
| WFC | Weifuchun,three times a day, four at a time,6months Receives: Drug: WFC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic effectiveness of gastric mucosal lesions
Referring to the CAG of the "Guidelines for Clinical Research on New Chinese Medicines (2002)", the effective treatment of gastric mucosal lesions is defined as "the pathological score decreased by 1 point compared with the previous point". The effective rate of gastric mucosal lesions treatment = the number of cases with a decrease of ≥ 1 point by the previous score / the total number of cases × 100%. The effective rate of gastric mucosal lesions from different category will be calculated: respectively for atrophy, chronic inflammation, activity, intestinal metaplasia, and intraepithelial neoplasia .
Measured: Half a year,a year
Secondary outcomes (3)
The efficacy of OLGA,OLGIM
The efficacy of OLGA staging: OLGA staging decreased by ≥1 stage compared with the baseline is considered as effecacy.The effective rate = the number of cases with ≥1 stage decreased compared with the previous stage/the total number of cases × 100%.
The efficacy of OLGIM staging:The OLGIM staging decreased by ≥1 stage from the baseline is considered effective for patients with intestinal metaplasia. The effective rate = the number of cases staging decreased by ≥ 1 stage compared with the previous stage /the total number of cases × 100%
Measured: Half a year,a year
Changes in clinical symptom scores
Evaluate referring to the symptom grading and quantification standard of "Guidelines for Clinical Research on Chronic Atrophic Gastritis" from "Guidelines for Clinical Research on New Chinese Medicines (2002)".According to the clinical symptom severity assign different points. No, mild, moderate and severe symptoms are recorded as 0, 1, 2, and 3 point respectively. Record the changes of the symptom score at 6 months and 12 months compared with the baseline and evaluate . The calculation formula is " the total score after treatment-the score in baseline ".
Measured: The third month,half a year ,the ninth month,a year.
The recurrence of HP
13C-UBT was performed to determine HP, and the DOB value more than 4 is defined as the recurrence of HP.
Measured: Half a year,a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start2 Aug 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (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.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388890
- Sponsor's protocol ID
- ShouFa-2022-2-4077
- Status last verified
- Aug 2023
- First submitted
- 19 May 2022
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Efficacy of Modified Liujunzi Prescription on the Treatment of Atrophic Gastritis After HP Eradication
- ClinicalTrials.gov ID
- NCT05388890
- Acronym / sponsor ID
- ShouFa-2022-2-4077
- Conditions
- Chronic Atrophic Gastritis
- Keywords
- Chronic Atrophic Gastritis, Modified Liujunzi Decoction, Treatment Based on Syndrome Differentiation, Clinical Study, Efficacy, Cohort Study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 May 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.
This is an observational cohort study of clinical efficacy study.The purpose of this topic is to evaluate the efficacy and safety of Modified Liujunzi Decoction based on syndrome differentiation in patients with chronic atrophic gastritis(CAG) after HP eradication.Taking Modified Liujunzi Decoction as the observation group and Weifuchun routine treatment as the control group, so as to provide evidence for the treatment of CAG and reduce the risk of gastric cancer. A total of 284 patients were included. The curative efficacy, symptom score and adverse events will be recorded and analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MLD | – | Drug: MLDModified Liujunzi Decoction,1 package twice daily,6 months |
| WFC | – | Drug: WFCWeifuchun,three times a day, four at a time,6months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- According to the willingness of the patients, the CAG patients after HP eradication in the routine diagnosis and treatment of the Department of integrated traditional Chinese and Western medicine and the Department of Gastroenterology of the Peking University First Hospital were enrolled.
Key inclusion criteria (5 listed)
- Patients with CAG diagnosed by endoscopy and pathological examination, the pathological diagnosis criteria refer to the China consensus of chronic gastritis (2017) ;
- Previous HP infection, HP negative after standardized treatment;
- TCM syndrome differentiation mainly focuses on the weakness of the spleen and stomach,referring to the consensus on the diagnosis and treatment of chronic atrophic gastritis with integrated traditional Chinese and Western Medicine (2017), there is no restriction on concurrent syndrome;
- Age 18-70 years old, regardless of gender;
- The subject (or legal representative) voluntarily agreed and signed the informed consent form, and was able to abide by the study protocol during the study.
Key exclusion criteria (5 listed)
- History of gastric surgery;
- Combined with serious diseases affecting the study evaluation, such as serious liver disease, heart disease, kidney disease, malignant tumor and alcoholism;
- Allergic to the drugs used in this study;
- Participated in clinical research of other drugs in the first 3 months of the study;
- Patients can't express correctly their subjective feelings and can't cooperate.
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 |
|---|---|---|
| MLDModified Liujunzi Decoction is provided by the chinese pharmacy of Peking University First Hospital , one dose per day, taken in twice, and the course of treatment is 6 months. | Drug | MLD |
| WFCChinese patent medicine, take according to the instructions, the course of treatment is 6 months. | Drug | WFC |
Primary outcome
Therapeutic effectiveness of gastric mucosal lesions
Time frame: Half a year,a year
Referring to the CAG of the "Guidelines for Clinical Research on New Chinese Medicines (2002)", the effective treatment of gastric mucosal lesions is defined as "the pathological score decreased by 1 point compared with the previous point". The effective rate of gastric mucosal lesions treatment = the number of cases with a decrease of ≥ 1 point by the previous score / the total number of cases × 100%. The effective rate of gastric mucosal lesions from different category will be calculated: respectively for atrophy, chronic inflammation, activity, intestinal metaplasia, and intraepithelial neoplasia .
3 secondary outcomes
The efficacy of OLGA,OLGIM
Time frame: Half a year,a year
Changes in clinical symptom scores
Time frame: The third month,half a year ,the ninth month,a year.
The recurrence of HP
Time frame: Half a year,a year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Atrophic Gastritis, run by Peking University First Hospital 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 5 inclusion and 5 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 5 Sep 2023. 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.
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 Qiuyue Huang, doctor (+86010 83572351 ext. 803, 1711210349@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic effectiveness of gastric mucosal lesions (time frame: Half a year,a year). 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 5 Sep 2023.