Prospective observational cohort study on the efficacy and safety of Evodia Radix Recipe in the treatment of chronic non-atrophic gastritis

Registration number:

ITMCTR2200006408

Date of Last Refreshed on:

2022-08-01

Date of Registration:

2022-08-01

Registration Status:

Prospective registration

Public title:

Prospective observational cohort study on the efficacy and safety of Evodia Radix Recipe in the treatment of chronic non-atrophic gastritis

English Acronym:

Scientific title:

Compatibility evaluation and biological basis of Evodia Fructus Recipe based on combination of clinical disease and syndrome

Scientific title acronym:

Study subject ID:

The registration number of the Partner Registry or other register:

ChiCTR2200062296 ; ChiMCTR2200006408

Applicant:

Manyi Jing

Study leader:

Yanling Zhao

Applicant telephone:

13552816266

Study leader's telephone:

13681208998

Applicant Fax:

Study leader's fax:

Applicant E-mail:

jingmanyi@yeah.net

Study leader's E-mail:

zhaoyl2855@126.com

Study leader's website(voluntary supply):

Study leader's website
(voluntary supply):

Applicant address:

No. 100, Middle West Fourth Ring Road, Fengtai District, Beijing

Study leader's address:

No. 100, Middle West Fourth Ring Road, Fengtai District, Beijing

Applicant postcode:

Study leader's postcode:

Applicant's institution:

Chinese People's Liberation Army General Hospital

Approved by ethic committee:

Approved No. of ethic committee:

KY-2022-2-6-1

Approved file of Ethical Committee:

View

Name of the ethic committee:

Medical Ethics Committee of Chinese People's Liberation Army General Hospital

Date of approved by ethic committee:

2022/2/15 0:00:00

Contact Name of the ethic committee:

Sujuan LI

Contact Address of the ethic committee:

No. 8 East Street, Fengtai District, Beijing

Contact phone of the ethic committee:

Contact email of the ethic committee:

Primary sponsor:

Fifth Medical Center of PLA General Hospital

Primary sponsor's address:

No. 100, Middle West Fourth Ring Road, Fengtai District, Beijing

Secondary sponsor:

Country:

China

Province:

Beijing

City:

Fengtai District

Institution
hospital:

Fifth Medical Center of PLA General Hospital

Address:

No. 100, Middle West Fourth Ring Road, Fengtai District, Beijing

Source(s) of funding:

National Natural Science Foundation of China major project

Target disease:

Chronic non-atrophic gastritis

Target disease code:

Study type:

Observational study

Study design:

Factorial

Study phase:

Others

Objectives of Study:

To clarify the scientific connotation of the combination of Evodia Fructus in the context of "combination of disease and syndrome", and to form a sensitive indicator for early toxicity early warning in clinic.

Description for medicine or protocol of treatment in detail:

Inclusion criteria

① Age 18 to 65 years old, male or female; ② Western medicine diagnosed as chronic non-atrophic gastritis; ③ TCM syndrome differentiation is the liver-fire invading stomach syndrome or liver-stomach deficiency-cold syndrome; ④ Subjects of childbearing age who voluntarily take effective contraceptive measures during the trial; ⑤ Voluntarily signed the informed consent.

Exclusion criteria:

① Gastroscopy with esophageal disease, peptic ulcer, tumor, bleeding lesions; ② Combined with severe dysplasia of gastric mucosa and pathological diagnosis of suspected malignant transformation; ③ Patients with autoimmune gastritis were excluded by serum gastrin, vitamin B12 levels and related autoantibodies (anti-parietal cell antibodies and anti-intrinsic factor antibodies); ④ Have serious primary heart, liver, lung, kidney, blood or serious diseases that affect their survival, such as tumors, AIDS or coagulation disorders; ⑤ Laboratory examination: Scr>N (N is the upper limit of normal value); ALT, AST>N; white blood cells <3.0×109/L; ⑥ Allergic constitution, such as those who are allergic to drugs or food; or those who are known to be allergic to research drugs; ⑦ Patients with alcoholism and drug dependence, with a history of epilepsy or with mental disorders; ⑧ Pregnant, lactating women or those planning to become pregnant; ⑨ Those who have participated in or are participating in other clinical trials within 3 months; ⑩ Other patients deemed unsuitable for the study by the investigator.

Study execute time:

From 2022-03-01

To      2025-03-01

Recruiting time:

From 2022-08-01

To      2025-03-01

Interventions:

475

Group:

Stomach heat syndrome

Sample size:

Intervention:

Zuojin pill

Intervention code:

475

Group:

Stomach cold syndrome

Sample size:

Intervention:

Wuzhuyu decoction

Intervention code:

Total sample size : 950

Countries of recruitment
and research settings:

Country:

China

Province:

Beijing

City:

Fengtai District

Institution/hospital:

Fifth Medical Center of PLA General Hospital

Level of the institution:

Tertiary A class

Country:

China

Province:

Beijing

City:

Haidian District

Institution/hospital:

Sixth Medical Center of PLA General Hospital

Level of the institution:

Tertiary A class

Country:

China

Province:

Beijing

City:

Xicheng District

Institution/hospital:

Guang'anmen hospiital of China academy of Chinese medical sciences

Level of the institution:

Tertiary A class

Outcomes:

Outcome:

Clinical observational indicators

Type:

Primary indicator

Measure time point of outcome:

Before and after treatment

Measure method:

Clinical Observation

Outcome:

Histopathological findings

Type:

Secondary indicator

Measure time point of outcome:

Before and after treatment

Measure method:

Histopathology

Outcome:

Liver damage indicators

Type:

Primary indicator

Measure time point of outcome:

Before and after treatment

Measure method:

Clinical symptoms and signs, biochemical test results

Outcome:

Kidney damage indicators

Type:

Primary indicator

Measure time point of outcome:

Before and after treatment

Measure method:

Biochemical test results

Outcome:

TCM syndrome score

Type:

Secondary indicator

Measure time point of outcome:

Before and after treatment

Measure method:

TCM Syndrome Differentiation

Outcome:

Nerve damage evaluation index

Type:

Primary indicator

Measure time point of outcome:

Before and after treatment

Measure method:

Clinical symptoms and signs

Outcome:

Endogenous metabolites

Type:

Secondary indicator

Measure time point of outcome:

Before and after treatment

Measure method:

Metabolomics, Transcriptomics and Microbiomics

Outcome:

Clinical efficacy indicators

Type:

Secondary indicator

Measure time point of outcome:

Before and after treatment

Measure method:

Clinical Observation

Outcome:

Gastroscopy results

Type:

Secondary indicator

Measure time point of outcome:

Before and after treatment

Measure method:

Gastroscopy

Collecting sample(s)
from participants:

Sample Name:

Blood

Tissue:

Blood

Fate of sample 

Destruction after use

Note:

For blood routine, liver and kidney function and metabolomics detection

Sample Name:

Stool

Tissue:

Stool

Fate of sample 

Destruction after use

Note:

For stool routine and intestinal flora detection

Sample Name:

Gastric mucosa

Tissue:

Gastric mucosa

Fate of sample 

Destruction after use

Note:

For histopathological and transcriptomic assays

Not yet recruiting

18
Min age years
65
Max age years

Recruiting status:

Participant age:

Gender:

Both

Randomization Procedure (please state who generates the random number sequence and by what method):

This study does not involve a randomized controlled design

Blinding:

IPD sharing:

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

This research will be published in academic papers

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

1 Data management For the specific requirements of data management, please refer to the "Data Management Plan", this plan only covers the general requirements of data management. 1.1 eCRF establishment In this experiment, an electronic data management system was used to collect and manage the experimental data, and the data management system was developed and maintained by MyMaster (Beijing) Information Technology Co., Ltd. Before designing an eCRF, an annotated CRF and an eCRF design description should be formulated first. Annotated CRF should indicate the variable name in the corresponding data column of the CRF. The data variable naming should conform to the current requirements of CFDA, and to meet the requirements of CDISC as much as possible. In addition, the annotated CRF/eCRF design description should at least include the data set to which the variable belongs, variable name and label, variable type, variable format and length, and variable assignment range. The eCRF design is performed according to the established Annotated CRF and eCRF Design Specifications. The database system has the function of checking the operation and modification records, and strictly implements the relevant SOP of the data management unit. Develop data entry instructions and require data entry and correction personnel to ensure accurate and complete entry according to the entry instructions. EDC is released for use after passing the test and being approved by the sponsor or the sponsor's authorizer; the PI, Sub-I, CRC, PM, CRA, DM, etc. of each role's authorized personnel can be officially launched and applied after training. 1.2 Data collection and entry The data collected in the source files will be recorded in the study medical records in a timely, complete, correct and clear manner by the investigators of each center, and then directly entered into the eCRF of this study by the investigators or authorized data entry personnel. Investigators at each center should ensure the accuracy, completeness, and timeliness of data submitted to the eCRF. A supervisor (CRA) monitors the conduct of the trial for adherence to the trial protocol. Verify that all study medical records are filled out correctly and consistent with the original data. If there are any errors or omissions, the researchers should be promptly requested to correct them. The original records should be kept clear and visible during revisions, and the corrections should be signed and dated by the researcher. There should be special records for the transmission of completed research medical records among investigators, supervisors, and data entry personnel, and corresponding signatures should be given upon receipt, and the records should be properly kept. Data entry personnel enter data using one-time entry. If problems or unexpected situations are found in the input process, they should be registered and reported in time so that the problems can be dealt with quickly. After data entry, a 100% source data verification (SDV) was performed by the monitor. 1.3 Data review and challenge handling The inspector is responsible for the on-site inspection of the center, and 100% checks whether the eCRF entry is correct and complete, and whether it is consistent with the original documents such as the original medical record and laboratory inspection report. The data management personnel conduct challenge management on the trial data according to the data verification plan (DVP). When data is entered into the EDC system, if there is illogical data, the system will automatically check and ask questions (Query); these queries need to be reviewed and answered by researchers or authorized personnel. In addition to the automatic verification of the system, questions that are manually verified by SAS programming or data administrators can be manually added to the EDC system when the researcher needs to clarify/verify/confirm. Researchers need to answer questions in a timely manner. Data administrators, supervisors, and medical staff will reply to questions, and if necessary, they can issue questions again until the data is "clean." 1.4 Investigator Signature The data administrator needs to confirm that all queries are cleaned up, and the researcher conducts an electronic signature review for confirmation. If there is any data revision after signing, it needs to be re-signed. 1.5 Medical Coding Medical coders perform medical coding jobs. The coding content includes concomitant medications and adverse events. Adverse events will be coded according to the MedDRA (version 17.0 or above) dictionary, and concomitant medications will be coded using the WHO ATC. During the coding process, if any medical term cannot be coded due to inappropriate, inaccurate, or vague provision of medical terms, the DM can challenge the researcher online in real time. Before the database was locked, the researchers reviewed the medical codes. 1.6 Data Lock and Export Complete the data lock library list, according to the database lock procedure, the data management personnel, statistical analysts, clinical monitor representatives, researcher representatives, etc. sign and approve the database lock file in writing, and the data administrator will export it to the database in the specified format. Submit it to the statistician for statistical analysis, and the locked data cannot be edited. After the data is locked, if there is definite evidence that it is necessary to unlock the data, the researchers and relevant personnel need to sign the unlocking document. 1.7 eCRF Archive At the end of the trial, the eCRF of each subject is exported to PDF for electronic archiving, and the CD-ROM is stored in the clinical trial unit for at least 5 years after the completion of the trial.

Data Managemen Committee:

Yes

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above