NCT05320133Enrolling By Invitation不适用
The Effect and Safety of Jinghua Weikang Capsule Containing Quadruple Therapy for IgAN With Helicobacter Pylori Infection, a Randomized Pilot Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Helicobacter pylori eradicaion rate
研究概览
简要总结
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IgA nephropathy diagnosed by renal biopsy;
- •Current Helicobacter pylori infection;
- •Age 18-65.
排除标准
- •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.
研究组 & 干预措施
JWC group
Experimental
Jinghua Weikang Capsule containing quadruple therapy.
干预措施: JWC containing quadruple therapy (Drug)
Control group
Active Comparator
Bismuth-containing quadruple therapy.
干预措施: Bismuth-containing quadruple therapy (Drug)
结局指标
主要结局
Helicobacter pylori eradicaion rate
时间窗: The forth week after the treatment.
The Helicobacter pylori infection status was measured by 13-carbon breath test.
次要结局
- eGFR(Baseline, the third and sixth month after the treatment, respectively.)
- Blood creatinine level(Baseline, the third and sixth month after the treatment, respectively.)
- Blood urea nitrogen level(Baseline, the third and sixth month after the treatment, respectively.)
- 24hrs urine protein level(Baseline, the third and sixth month after the treatment, respectively.)
- Blood presure(Baseline, the third and sixth month after the treatment, respectively.)
- IgA level(Baseline, the third and sixth month after the treatment, respectively.)
- IgA1 level(Baseline, the third and sixth month after the treatment, respectively.)
- Gd-IgA1 level(Baseline, the third and sixth month after the treatment, respectively.)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
Clinical evaluation of Jinghua Weikang Capsule in the treatment of Helicobacter pylori infection in the elderly: a randomized, placebo-conrtolled trialHealth development and scientific reasearch in the capitalITMCTR1900002852Peking Univeisity First Hospital
已完成
2 期
Efficacy and Safety of Jinshuibao Capsule on Diabetic Kidney DiseaseDiabetic Kidney DiseaseType 2 Diabetes MellitusNCT03164785Second Xiangya Hospital of Central South University202
招募中
2 期
HuHuangLianzonggan Capsule in Subjects With Nonalcoholic Steatohepatitis: a Phase 2 tRial(HHL-HEPAR)NASHNCT05632861Tasly Pharmaceutical Group Co., Ltd76
已完成
4 期
Effectiveness and safety of Hongjin Xiaojie Capsule versus waiting list for breast paiBreast painSigns and SymptomsISRCTN44184398Yunnan Yousheng Pharmaceutical Co., Ltd298
尚未招募
4 期
Efficacy and safety of Zhenyuan capsule in improving the glucose metabolism of pre-diabetes patients: a randomized controlled trialITMCTR2000003411Xiyuan Hospital, China Academy of Chinese Medical Sciences