NCT01474044已完成4 期
A Phase IV Study to Evaluate the Efficacy and Safety of Vitamin B12 Contains Extract of Lamb's Stomach in Treatment of Chronic Atrophic Gastritis
Xinjiang Biochemical Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 851 人开始时间: 2011年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 851
- 试验地点
- 1
- 主要终点
- Effective rate confirmed by histology
研究概览
简要总结
The purpose of this study is to determine whether Gastropyloric Complex Capsules are safe and effective in the treatment of chronic atrophic gastritis (CAG).
详细描述
Till now, there is no ideal treatment to chronic atrophic gastritis(CAG). This study is try to find a possible treatment to CAG with Gastropyloric Complex Capsules.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years, male or female
- •Histologically diagnosed CAG
- •HP negative confirmed by gastric mucosal staining
- •Signed an written informed consent
排除标准
- •CAG with high-grade intraepithelial neoplasia
- •Severe gastric mucosal erosion or bleeding needing treatment
- •Active peptic ulcer, GERD, or esophageal stricture
- •History of upper GI tract surgery
- •History of malignant diseases
- •With depression, anxiety neuroses, or hysteria
- •Heart failure (NYHA class lll or lV), liver disease (ALT ≥ 80 IU/L, AST ≥ 80 IU/L) or renal disease(Cr ≥ 150 ummol/L)
- •Uncontrolled hypertension
- •Uncontrolled diabetes
- •Alcohol abuse
- •Drug allergy
- •Participated in another investigational study within 4 weeks prior to Visit 0
- •Pregnancy, be a nursing mother or without conception control
- •There is any concern by the investigator regarding the safe participation of the participant in the study or for any other reason; the investigator considers the participant inappropriate for participation in the study
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo Comparator (Other)
Gastropyloric Complex Capsules
Active Comparator
干预措施: Gastropylor Complex Capsules (Drug)
结局指标
主要结局
Effective rate confirmed by histology
时间窗: within 180 days after treatment
All patients are required to repeat the histology examination after 180 days follow-up is completed.
次要结局
- clinical manifestations including abdominal pain, anorexia, nausea, vomiting, and belching(within 180 days after treatment)
研究者
研究点 (1)
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