Clinical trial NCT03823248: Jianpi Huoxue Recipe in Treating Gastric Premalignant Lesion
Official title: Therapeutic Mechanism of Jianpi Huoxue Recipe in Treating Gastric Premalignant Lesion：A Multi-center, Randomized and Controlled Experiment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Gastric Precancerous Condition
Lead sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Beijing Friendship Hospital
name: Wuhan Integrated Traditional Chinese and Western Medicine Hospital
name: The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
name: The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine
name: The Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine
name: Traditional Chinese Medicine Hospital of KUNSHAN
name: Yueyang Hospital of Integrated Traditional Chinese and Western Medicine
First posted: 2019-01-30
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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.

Primary outcomes:
measure: The disappearance rate of dysplasia
timeFrame: six months
measure: The score changes of histopathology
timeFrame: six months
Secondary outcomes:
measure: The score changes of Endoscopic Findings
timeFrame: six months
measure: Main symptom score
timeFrame: six months
measure: The patient-reported outcome (PRO)scale integrals
timeFrame: six months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Study officials:
References: