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NCT03823248

Jianpi Huoxue Recipe in Treating Gastric Premalignant Lesion

Status unknown Phase 1, PHASE2 Last updated 25 June 2021
What this trial tests

Phase 1, PHASE2 trial testing MoLuoDan in Gastric Precancerous Condition in 480 participants. Status unknown.

Timeline
1 March 2019
Primary endpoint
31 December 2021
31 December 2021

Quick facts

Lead sponsorXiyuan Hospital of China Academy of Chinese Medical Sciences
PhasePhase 1, PHASE2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment480
Start date1 March 2019
Primary completion31 December 2021
Estimated completion31 December 2021
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Who can join

Adults 18 to 75, any sex, with Gastric Precancerous Condition. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Traditional Chinese medicine for transformation of gastric precancerous lesions to gastric cancer: A critical review.
    Zhong YL, Wang PQ, Hao DL, Sui F, et al · · 2023 · cited 16× · PMID 36684050 · DOI 10.4251/wjgo.v15.i1.36

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