Jinghua Weikang Capsule Containing Quadruple Therapy for IgAN With Helicobacter Pylori Infection
2022年10月17日 更新者：Peking University First Hospital
The Effect and Safety of Jinghua Weikang Capsule Containing Quadruple Therapy for IgAN With Helicobacter Pylori Infection, a Randomized Pilot Study
This study is to evaluate the efficacy and safety of the Jinghua Weikang Capsule (a Chinese patent medicine for peptic ulcer and gastritis) containing quadruple therapy (Jinghua Weikang Caplsule plus triple therpy) for eradicating Helicobacter pylori in IgA nephropathy.
研究概览
地位
邀请报名
条件
研究类型
介入性
注册 (预期的)
80
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Beijing
-
Beijing、Beijing、中国、100034
- Peking University First Hospital
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- IgA nephropathy diagnosed by renal biopsy;
- Current Helicobacter pylori infection;
- Age 18-65.
Exclusion Criteria:
- ①eGFR<90ml/（min·1.73m2）-
- History of Helicobacter pylori treatment
- Present taking hormones or immunosuppressants
- Malignant tumor and high-grade intraepithelial neoplasia and severe dysplasia of gastric mucosa
- Allergy history to medicines used in the study
- History of gastric surgery
- Uncontrolled chronic diseases such as diabetes, cardiovascular and cerebrovascular diseases, respiratory diseases, mental disorders and other researchers are considered to affect treatment and assessment
- Combined with other primary or secondary nephropathy except for IgAN
- Combined with acute renal injury
- Female patients with pregnancy, lactation and planned pregnancy.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：JWC group
Jinghua Weikang Capsule containing quadruple therapy.
|
Subjects will receive the rabeprazole 10mg, moxycillin 1.0g, clarithromycin 500mg and Jinghua Weikang Capsule 240mg twice daily for 14 days.
|
|
有源比较器：Control group
Bismuth-containing quadruple therapy.
|
Subjects will receive the rabeprazole 10mg, moxycillin 1.0g, clarithromycin 500mg and bismuth potassium citrate 220mg twice daily for 14 days.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Helicobacter pylori eradicaion rate
大体时间：The forth week after the treatment.
|
The Helicobacter pylori infection status was measured by 13-carbon breath test.
|
The forth week after the treatment.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Blood creatinine level
大体时间：Baseline, the third and sixth month after the treatment, respectively.
|
The change of average blood creatinine level between two groups.
|
Baseline, the third and sixth month after the treatment, respectively.
|
|
Blood urea nitrogen level
大体时间：Baseline, the third and sixth month after the treatment, respectively.
|
The change of average blood urea nitrogen level between two groups.
|
Baseline, the third and sixth month after the treatment, respectively.
|
|
eGFR
大体时间：Baseline, the third and sixth month after the treatment, respectively.
|
The change of average eGFR level between two groups.
|
Baseline, the third and sixth month after the treatment, respectively.
|
|
24hrs urine protein level
大体时间：Baseline, the third and sixth month after the treatment, respectively.
|
The change of average24hrs urine protein level between two groups.
|
Baseline, the third and sixth month after the treatment, respectively.
|
|
Blood presure
大体时间：Baseline, the third and sixth month after the treatment, respectively.
|
The change of average blood presure level between two groups.
|
Baseline, the third and sixth month after the treatment, respectively.
|
|
IgA level
大体时间：Baseline, the third and sixth month after the treatment, respectively.
|
The change of average IgA level level between two groups.
|
Baseline, the third and sixth month after the treatment, respectively.
|
|
IgA1 level
大体时间：Baseline, the third and sixth month after the treatment, respectively.
|
The change of average IgA1 level between two groups.
|
Baseline, the third and sixth month after the treatment, respectively.
|
|
Gd-IgA1 level
大体时间：Baseline, the third and sixth month after the treatment, respectively.
|
The change of average Gd-IgA1 level level between two groups.
|
Baseline, the third and sixth month after the treatment, respectively.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：HUI YE、Peking University First Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2022年6月20日
初级完成 (预期的)
2024年11月30日
研究完成 (预期的)
2024年12月31日
研究注册日期
首次提交
2022年3月30日
首先提交符合 QC 标准的
2022年4月8日
首次发布 (实际的)
2022年4月11日
研究记录更新
最后更新发布 (实际的)
2022年10月18日
上次提交的符合 QC 标准的更新
2022年10月17日
最后验证
2022年10月1日
更多信息
与本研究相关的术语
其他研究编号
- 2021CR36
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
IPD will be shared on https://clinicaltrials.gov.
IPD 共享时间框架
The data will be uploaded within 6 month after Dec 31, 2024.
IPD 共享访问标准
The user of ClinicalTrials.gov
PRS could access the data.
IPD 共享支持信息类型
- 研究方案
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.