Jianpi Huoxue Recipe in Treating Gastric Premalignant Lesion
Status:
Recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
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
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