Jianpi Huoxue Recipe in Treating Gastric Premalignant Lesion

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Gastric Precancerous Condition

Treatments: Drug: Sanchi powder simulation; Drug: Sanchi powder; Drug: Folic Acid Tablet; Drug: Folic Acid Tablet simulation; Drug: MoLuoDan simulation; Drug: MoLuoDan

Study type: Interventional

Funder types: Other

Identifiers

NCT03823248

2017YFC1700601

Details and patient eligibility

About

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.

Full 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.

Enrollment: 480 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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480 participants in 2 patient groups

MoLuoDan and Sanchi powder group

Experimental group

Description:

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.

Treatment:

Drug: Sanchi powder

Drug: Folic Acid Tablet simulation

Drug: MoLuoDan

Folic Acid Tablet group

Active Comparator group

Description:

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.

Treatment:

Drug: Sanchi powder simulation

Drug: Folic Acid Tablet

Drug: MoLuoDan simulation