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NCT03823248
Jianpi Huoxue Recipe in Treating Gastric Premalignant Lesion
Phase 1, PHASE2 trial testing MoLuoDan in Gastric Precancerous Condition in 480 participants. Status unknown.
31 December 2021
Quick facts
| Lead sponsor | Xiyuan Hospital of China Academy of Chinese Medical Sciences |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 480 |
| Start date | 1 March 2019 |
| Primary completion | 31 December 2021 |
| Estimated completion | 31 December 2021 |
| Sites | 1 location across China |
Drugs / interventions tested
- MoLuoDan — full drug profile →
- Sanchi powder — full drug profile →
- Folic Acid Tablet
- MoLuoDan simulation — full drug profile →
- Sanchi powder simulation — full drug profile →
- Folic Acid Tablet simulation — full drug profile →
Conditions studied
- Gastric Precancerous Condition — all drugs for Gastric Precancerous Condition →
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):
-
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
Verify or expand the search:
- PubMed search for NCT03823248
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03823248 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Last refreshed: 25 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03823248.
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