Jianpi Huoxue Recipe in Treating Gastric Premalignant Lesion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gastric Precancerous Condition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

MoLuoDan

Intervention Type DRUG

oral administration of Moluodan concentrated pills with warm water before meal for 8 pills each time for three times a day

Sanchi powder

Intervention Type DRUG

oral administration of Sanchi powder mixing with warm water before meal for 3g each time for twice a day

Folic Acid Tablet simulation

Intervention Type DRUG

oral administration of folic acid simulation tablets half a hour after meal for 5 mg each time for 3 times a day.

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.

Group Type ACTIVE_COMPARATOR

Folic Acid Tablet

Intervention Type DRUG

oral administration of folic acid tablets half an hour after meal for 5 mg each time for 3 times a day.

MoLuoDan simulation

Intervention Type DRUG

oral administration of Moluodan simulation medicine with warm water before meal for 8 pills each time for three times a day

Sanchi powder simulation

Intervention Type DRUG

oral administration of Sanchi powder simulation medicine mixing with warm water before meal for 3g each time for twice a day

Interventions

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MoLuoDan

oral administration of Moluodan concentrated pills with warm water before meal for 8 pills each time for three times a day

Intervention Type DRUG

Sanchi powder

oral administration of Sanchi powder mixing with warm water before meal for 3g each time for twice a day

Intervention Type DRUG

Folic Acid Tablet

oral administration of folic acid tablets half an hour after meal for 5 mg each time for 3 times a day.

Intervention Type DRUG

MoLuoDan simulation

oral administration of Moluodan simulation medicine with warm water before meal for 8 pills each time for three times a day

Intervention Type DRUG

Sanchi powder simulation

oral administration of Sanchi powder simulation medicine mixing with warm water before meal for 3g each time for twice a day

Intervention Type DRUG

Folic Acid Tablet simulation

oral administration of folic acid simulation tablets half a hour after meal for 5 mg each time for 3 times a day.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Outpatients and inpatients diagnosed with chronic atrophic gastritis accompanying with low grade intraepithelial neoplasia and indefinite dysphasia confirmed by gastroscopy and histopathological examination;
2. Patients aged from 18-75 years;
3. Subjects who were informed and voluntarily signed the informed consent.

Exclusion Criteria

1. Patients pathohistologically diagnosed with high grade intraepithelial neoplasia/severe dysplasia;
2. Patients with a history of gastric ulcer, gastric polyps and gastric surgery;
3. Patients taking NSAIDs for a long term;
4. Patients suspected of gastric cancer or malignant lesions in other systems;
5. Patients with a history of gastric surgery;
6. 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)
7. Patients with mental disease, dysgnosia and logopathy;
8. Pregnant women, or those preparing a pregnancy and breastfeeding women;
9. Patients with a allergic history of medicines used in this experiment.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No