Therapeutic Mechanism of Jianpi Huoxue Recipe in Treating Gastric Premalignant Lesion：A Multi-center, Randomized and Controlled Experiment
试验速览
- 阶段
- 1 期
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- The disappearance rate of dysplasia
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients and inpatients diagnosed with chronic atrophic gastritis accompanying with low grade intraepithelial neoplasia and indefinite dysphasia confirmed by gastroscopy and histopathological examination;
- •Patients aged from 18-75 years;
- •Subjects who were informed and voluntarily signed the informed consent.
排除标准
- •Patients pathohistologically diagnosed with high grade intraepithelial neoplasia/severe dysplasia;
- •Patients with a history of gastric ulcer, gastric polyps and gastric surgery;
- •Patients taking NSAIDs for a long term;
- •Patients suspected of gastric cancer or malignant lesions in other systems;
- •Patients with a history of gastric surgery;
- •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)
- •Patients with mental disease, dysgnosia and logopathy;
- •Pregnant women, or those preparing a pregnancy and breastfeeding women;
- •Patients with a allergic history of medicines used in this experiment.
研究组 & 干预措施
MoLuoDan and Sanchi powder group
Experiment group: oral administration of Moluodan concentrated pills with warm water before meal for 8 pills each time for three times a day, + oral administration of Sanchi powder mixing with warm water before meal for 3g each time for twice a day, + oral administration of Folic Acid Tablet simulation half a hour after meal for 5 mg each time for 3 times a day. The medication period was 24 weeks.
干预措施: MoLuoDan (Drug)
MoLuoDan and Sanchi powder group
Experiment group: oral administration of Moluodan concentrated pills with warm water before meal for 8 pills each time for three times a day, + oral administration of Sanchi powder mixing with warm water before meal for 3g each time for twice a day, + oral administration of Folic Acid Tablet simulation half a hour after meal for 5 mg each time for 3 times a day. The medication period was 24 weeks.
干预措施: Sanchi powder (Drug)
MoLuoDan and Sanchi powder group
Experiment group: oral administration of Moluodan concentrated pills with warm water before meal for 8 pills each time for three times a day, + oral administration of Sanchi powder mixing with warm water before meal for 3g each time for twice a day, + oral administration of Folic Acid Tablet simulation half a hour after meal for 5 mg each time for 3 times a day. The medication period was 24 weeks.
干预措施: Folic Acid Tablet simulation (Drug)
Folic Acid Tablet group
Control group: oral administration of Moluodan simulation medicine with warm water before meal for 8 pills each time for three times a day, + oral administration of Sanchi powder simulation medicine mixing with warm water before meal for 3g each time for twice a day, + oral administration of folic acid tablets half a hour after meal for 5 mg each time for 3 times a day. The medication period was 24 weeks.
干预措施: Folic Acid Tablet (Drug)
Folic Acid Tablet group
Control group: oral administration of Moluodan simulation medicine with warm water before meal for 8 pills each time for three times a day, + oral administration of Sanchi powder simulation medicine mixing with warm water before meal for 3g each time for twice a day, + oral administration of folic acid tablets half a hour after meal for 5 mg each time for 3 times a day. The medication period was 24 weeks.
干预措施: MoLuoDan simulation (Drug)
Folic Acid Tablet group
Control group: oral administration of Moluodan simulation medicine with warm water before meal for 8 pills each time for three times a day, + oral administration of Sanchi powder simulation medicine mixing with warm water before meal for 3g each time for twice a day, + oral administration of folic acid tablets half a hour after meal for 5 mg each time for 3 times a day. The medication period was 24 weeks.
干预措施: Sanchi powder simulation (Drug)
结局指标
主要结局
The disappearance rate of dysplasia
时间窗: six months
The all patients' histopathology will be evaluated two times, the first time is when the patients' are included into the clinical trials, the second time is after 24 weeks treatment in each group, patients' histopathology should be evaluated for comparison between two groups,at the same time patients' histopathology should be evaluated for comparison in each group.The change in histological score (mean score of all biopsie after treatment in each group and between groups was calculated. The response rate of each pathological lesion was calculated as a percentage of those improved or disappeared at the 6th month to all subjects. The disappearance rate of dysplasia between groups were compared, which was defined as the absence of dysplasia (score 0) in all biopsy specimens after treatment.
The score changes of histopathology
时间窗: six months
The score changes of atrophy, intestinal metaplasia, chronic inflammation and active inflammation compared between baseline and after 6-month treatment.
次要结局
- The score changes of Endoscopic Findings(six months)
- Main symptom score(six months)
- The patient-reported outcome (PRO)scale integrals(six months)