- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03823248
Jianpi Huoxue Recipe in Treating Gastric Premalignant Lesion
June 23, 2021 updated by: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Therapeutic Mechanism of Jianpi Huoxue Recipe in Treating Gastric Premalignant Lesion:A Multi-center, Randomized and Controlled Experiment
This study had adopted the multi-center, randomized and controlled experiment design based on standardized mucosal biopsy and pathohistological operation, as well as therapeutic evaluation methodology.
Meanwhile, patients diagnosed with chronic atrophic gastritis accompanying with low grade intraepithelial neoplasia and indefinite dysphasia (grade C2/C3 of Vienna classification) confirmed by gastroscopic histopathology were enrolled as the objects of study, while folic acid was used as the control.
The therapeutic effect and safety of Jianpi Huoxue Recipe (Moluodan + Sanchi powder) in intervening the gastric Premalignant lesion were evaluated from the points of view of pathology, gastroscopy and symptoms.
The elimination rate of intraepithelial neoplasia of gastric mucosa was expected to be improved by 9-12%.
Moreover, high quality evidence-based medical evidence regarding traditional Chinese medicine (TCM) in intervening gastric Premalignant lesion would be obtained, which could form the mature, propagable and effective scheme.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Intraepithelial neoplasia of gastric mucosa is a well-recognized gastric Premalignant lesion, which is the key of secondary prevention for gastric cancer.
However, no universally acknowledged effective therapeutic scheme is available at present.
Previously, the investigator's research group has carried out clinical trial study based on solving the key problems such as diagnostic criteria, mucosal biopsy consistency and therapeutic evaluation methodology, and has attained certain achievements.
This study had adopted the multi-center, randomized and controlled experiment design based on standardized mucosal biopsy and pathohistological operation, as well as therapeutic evaluation methodology.
Meanwhile, patients diagnosed with chronic atrophic gastritis accompanying with low grade intraepithelial neoplasia and indefinite dysphasia (grade C2/C3 of Vienna classification) confirmed by gastroscopic histopathology were enrolled as the objects of study, while folic acid was used as the control.
The therapeutic effect and safety of Jianpi Huoxue Recipe (Moluodan + Sanchi powder) in intervening the gastric Premalignant lesion were evaluated from the points of view of pathology, gastroscopy and symptoms.
The elimination rate of intraepithelial neoplasia of gastric mucosa was expected to be improved by 9-12%.
Moreover, high quality evidence-based medical evidence regarding traditional Chinese medicine (TCM) in intervening gastric Premalignant lesion would be obtained, which could form the mature, propagable and effective scheme.
At the same time, molecular and biological indicators, including CDX2, SOX2, MUC2, MUC6, MUC5AC and CD10, were detected using the pathological tissues, so as to explore the therapeutic mechanism of Jianpi Huoxue Recipe in intervening gastric Premalignant lesion, and to construct the model platform for special disease research on gastric Premalignant lesion.
Study Type
Interventional
Enrollment (Anticipated)
480
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xiangxue Ma, Doctor
- Phone Number: +86(010)62835641
- Email: maxiangxue@163.com
Study Locations
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-
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Beijing, China, 100091
- Recruiting
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
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Contact:
- Xiangxue Ma
- Email: maxiangxue@163.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Outpatients and inpatients diagnosed with chronic atrophic gastritis accompanying with low grade intraepithelial neoplasia and indefinite dysphasia confirmed by gastroscopy and histopathological examination;
- Patients aged from 18-75 years;
- Subjects who were informed and voluntarily signed the informed consent.
Exclusion Criteria:
- Patients pathohistologically diagnosed with high grade intraepithelial neoplasia/severe dysplasia;
- Patients with a history of gastric ulcer, gastric polyps and gastric surgery;
- Patients taking NSAIDs for a long term;
- Patients suspected of gastric cancer or malignant lesions in other systems;
- Patients with a history of gastric surgery;
- Patients with concurrent primary diseases in cardiovascular, cerebrovascular, liver, kidney and hemopoietic systems (ALT>80 u/L, and/or AST>80 u/L, with abnormal renal function)
- Patients with mental disease, dysgnosia and logopathy;
- Pregnant women, or those preparing a pregnancy and breastfeeding women;
- Patients with a allergic history of medicines used in this experiment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MoLuoDan and Sanchi powder group
Experiment group: oral administration of Moluodan concentrated pills with warm water before meal for 8 pills each time for three times a day, + oral administration of Sanchi powder mixing with warm water before meal for 3g each time for twice a day, + oral administration of Folic Acid Tablet simulation half a hour after meal for 5 mg each time for 3 times a day.
The medication period was 24 weeks.
|
oral administration of Moluodan concentrated pills with warm water before meal for 8 pills each time for three times a day
oral administration of Sanchi powder mixing with warm water before meal for 3g each time for twice a day
oral administration of folic acid simulation tablets half a hour after meal for 5 mg each time for 3 times a day.
|
Active Comparator: Folic Acid Tablet group
Control group: oral administration of Moluodan simulation medicine with warm water before meal for 8 pills each time for three times a day, + oral administration of Sanchi powder simulation medicine mixing with warm water before meal for 3g each time for twice a day, + oral administration of folic acid tablets half a hour after meal for 5 mg each time for 3 times a day.
The medication period was 24 weeks.
|
oral administration of folic acid tablets half an hour after meal for 5 mg each time for 3 times a day.
oral administration of Moluodan simulation medicine with warm water before meal for 8 pills each time for three times a day
oral administration of Sanchi powder simulation medicine mixing with warm water before meal for 3g each time for twice a day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The disappearance rate of dysplasia
Time Frame: six months
|
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.The change in histological score (mean score of all biopsie after treatment in each group and between groups was calculated.
The response rate of each pathological lesion was calculated as a percentage of those improved or disappeared at the 6th month to all subjects.
The disappearance rate of dysplasia between groups were compared, which was defined as the absence of dysplasia (score 0) in all biopsy specimens after treatment.
|
six months
|
The score changes of histopathology
Time Frame: six months
|
The score changes of atrophy, intestinal metaplasia, chronic inflammation and active inflammation compared between baseline and after 6-month treatment.
|
six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The score changes of Endoscopic Findings
Time Frame: six months
|
The score changes of endoscopic findings, such as erosion, bleeding, coarse and uneven mucosa, and bile reflux were compared between baseline and after 6-month treatment.
|
six months
|
Main symptom score
Time Frame: six months
|
Changes of symptom score were compared.
The symptom include upper abdominal pain, upper abdominal distension, poor appetite, nausea and belching.
The disappearance rate of symptom was expressed as a percentage of the subjects whose symptoms disappeared after medication to those exhibiting symptoms before medication.
|
six months
|
The patient-reported outcome (PRO)scale integrals
Time Frame: six months
|
The patient-reported outcome (PRO) instrument for chronic gastrointestinal diseases was a 35-item instrument, including 6 dimensions of regurgitation, dyspepsia, defecation, general condition, emotion and social function.
All items graded into 5 levels and scored 0-4, except for decreased appetite, which is grouped into 4 levels and scored 0-3.
|
six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2019
Primary Completion (Anticipated)
December 31, 2021
Study Completion (Anticipated)
December 31, 2021
Study Registration Dates
First Submitted
July 11, 2018
First Submitted That Met QC Criteria
January 27, 2019
First Posted (Actual)
January 30, 2019
Study Record Updates
Last Update Posted (Actual)
June 25, 2021
Last Update Submitted That Met QC Criteria
June 23, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017YFC1700601
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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