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临床试验/NCT02797028
NCT02797028Unknown4 期

Investigation of the Atherogenic Effects of Uric Acid-modified in Endothelial Dysfunction and the the Preventional Mechanism by Anthocyanidines

Guangzhou General Hospital of Guangzhou Military Command1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2015年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
320
试验地点
1
主要终点
Measurement of serum uric acid levels in all patients

研究概览

简要总结

The purpose of this study is to confirm the protective effect and mechanism of anthocyanins on hyperuricemia patients with Cardiovascular disease.

详细描述

Hyperuricemia patients who have the ability to complete the intervention study in the early stage of study were selected as the research subjects. A randomized controlled double blind control method was used to study the effect of one year of anthocyanins intervention. Serum UA levels, oxidative stress, AGEs, and endothelial function are detecting in patients with hyperuricemia who were treated with anthocyanins and placebo. Providing scientific basis of anthocyanins for the treatment with hyperuricemia and delaying atherosclerosis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Serum uric acid >420μmol/L (7mg/dL) in male, >360μmol/L (6mg/dL) in female identified as hyperuricemia patients.

排除标准

  • Age more than 60 years and less than 30 years old;
  • acute infection, tumor, recent surgery, need for hemodialysis and autoimmune diseases.

研究组 & 干预措施

Placebo capsule

Placebo Comparator

Simple hyperuricemia patients and with coronary heart disease in hospital. Double blind, randomized method. Control group taking placebo capsule

干预措施: Placebo capsule (Dietary Supplement)

Anthocyanidins capsule

Experimental

Simple hyperuricemia patients and with coronary heart disease in hospital. Double blind, randomized method. The experimental group taking anthocyanins capsule.

干预措施: Anthocyanidins capsule (Dietary Supplement)

Allopurinol

Experimental

The experimental group taking allopurinol.

干预措施: Allopurinol (Drug)

结局指标

主要结局

Measurement of serum uric acid levels in all patients

时间窗: up to 1 months

Serum uric acid (mg/dl) is determined by Uric Acid kit on an automated system.

次要结局

  • Measurement of advanced glycation end products and its receptor level in all patients(up to 2 months)

研究者

发起方
Guangzhou General Hospital of Guangzhou Military Command
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yuan Zhang

Doctor of Medicine

Guangzhou General Hospital of Guangzhou Military Command

研究点 (1)

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