Yiwei Jiaohuang Ointment for Gastrointestinal Bleeding Associated With Oral Antithrombotic Agents: A Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The rate of negative fecal occult blood test results in the two groups of patients after 2 weeks of intervention.
研究概览
简要总结
The goal of this clinical trial is to evaluate the clinical efficacy and safety of YiWei Jiaohuang Ointment in treating gastrointestinal bleeding associated with oral antithrombotic therapy. The main question it aims to answer is:
Does Yiwei JiaoHuang Ointment accelerate the conversion to negative results in fecal occult blood tests among patients with gastrointestinal bleeding associated with antithrombotic therapy? Researchers will compare use rabeprazole alone as routine therapy to see if Yiwei JiaoHuang Ointment can accelerate the conversion to negative results in fecal occult blood tests.
Participants will ： Take Yiwei JiaoHuang Ointment every day for 2 weeks. Return to the hospital for a fecal occult blood test after 3 days, 1 week, and 2 weeks of medication.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Oral therapy with at least one antiplatelet or anticoagulant agent, including: aspirin, clopidogrel, ticagrelor, prasugrel, warfarin, rivaroxaban, apixaban, edoxaban, dabigatran, etc.;
- •BARC stage 1 or 2;
- •Traditional Chinese Medicine pattern identified as phlegm-heat and blood stasis obstruction syndrome;
- •Age 18-90 years;
- •Signed informed consent.
排除标准
- •Patients with gastrointestinal bleeding resulting in hemoglobin levels <20 g/L and/or requiring hospitalization;
- •Gastrointestinal malignancies;
- •Cases where the source of occult blood cannot be distinguished, such as fresh bleeding from hemorrhoids;
- •Concurrent use of hemostatic traditional Chinese medicine preparations like Yunnan Baiyao;
- •Significant liver or kidney dysfunction, with ALT, AST, or serum creatinine exceeding three times the upper limit of normal;
- •Pregnant women, women planning pregnancy, or lactating women;
- •Individuals deemed unsuitable for this clinical trial by the investigator.
研究组 & 干预措施
Intervention
干预措施: A Chinese herb formula--Yiwei Jiaohuang Onitment (Drug)
Intervention
干预措施: Rabeprazole Enteric-Coated Tablets (Drug)
Control
干预措施: Rabeprazole Enteric-Coated Tablets (Drug)
结局指标
主要结局
The rate of negative fecal occult blood test results in the two groups of patients after 2 weeks of intervention.
时间窗: two weeks of intervention
次要结局
- Time required for fecal occult blood to turn negative in two groups of patients.(two weeks of intervention)
- The rate of negative fecal occult blood test results in the two groups of patients after 3 days of intervention.(3 days of intervention)
- The rate of negative fecal occult blood test results in the two groups of patients after one week of intervention.(one week of intervention)
- Changes in hemoglobin levels in two groups of patients after 2 weeks of intervention.(two weeks of intervention)
研究者
Jie, Zhang
Attending Physician
China-Japan Friendship Hospital