NCT03823248

Jianpi Huoxue Recipe in Treating Gastric Premalignant Lesion

Therapeutic Mechanism of Jianpi Huoxue Recipe in Treating Gastric Premalignant Lesion：A Multi-center, Randomized and Controlled Experiment

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Gastric Precancerous Condition

Interventions

Type	Name	Description
DRUG	MoLuoDan	oral administration of Moluodan concentrated pills with warm water before meal for 8 pills each time for three times a day
DRUG	Sanchi powder	oral administration of Sanchi powder mixing with warm water before meal for 3g each time for twice a day
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.
DRUG	MoLuoDan simulation	oral administration of Moluodan simulation medicine with warm water before meal for 8 pills each time for three times a day
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
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.

Timeline

• Start date: 2019-03-01
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2019-01-30
• Last updated: 2021-06-25

Locations

1 site across 1 country: China