Jianpi Huoxue Recipe in Treating Gastric Premalignant Lesion

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Collaborators: Beijing Friendship Hospital; Guangdong Provincial Hospital of Traditional Chinese Medicine; The Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine; The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine; The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine; Traditional Chinese Medicine Hospital of KUNSHAN; Wuhan Integrated Traditional Chinese and Western Medicine Hospital; Yueyang Hospital of Integrated Traditional Chinese and Western Medicine
• Treatments: Folic Acid; Vitamin B Complex

Criteria

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.