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临床试验/NCT01917123
NCT01917123Unknown早期 1 期

Phase 0 Study of The Effect of L-Citrulline Malate on Ankle Brachial Index Among Patients With Coronary Heart Disease According to Their Smoking History

Masih Daneshvari Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
发起方
入组人数
20
试验地点
1
主要终点
Brachial Index

研究概览

简要总结

In this randomized clinical trial before and after study we will assess the effect of L-citrulline malate on brachial index in patients with coronary heart disease based on their smoking history. Twenty patients with coronary heart disease with no history of diabetes or other chronic diseases and with no history of myocardial infarction in the last 6 months will participate in our trial.A written well-versed permission was attained from all patients. We will measure the brachial index tow times once before giving L-Citrulline malate and the other time after 2 weeks giving it.Patients receiving L-Citrulline malate as a 1 gram dry powder agent twice a day, that should in use with 250 mg dilute water .The patients will followed after 2 weeks by measuring brachial index which is our primary outcome measurement in this trial.We assumed that the brachial index in both smoker and non-smoker group of patients with coronary heart disease would change to normal or close to normal after giving 1 gram L-citrulline malate twice a day for 2 weeks.

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
16 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1- patients with coronary heart disease without history of diabetes or any chronic disease 2- no myocardial infarction in last 6 months 3-ejection fraction more than 50% 4- please to recruit in the trial 5-no uncontrolled blood pressure 6- with stable condition when come to the clinic

排除标准

  • 1- those who refuse to being in the trial 2- those which their total condition become worse 3- CCU admission as a result of being unstable 4- patients with chronic heart failure(CHF)

研究组 & 干预措施

Stimol, Brachial Index, Powder agent

Active Comparator

L-Citrulline malate,1gr,twice a day,2weeks

干预措施: L-Citrulline malate (Drug)

结局指标

主要结局

Brachial Index

时间窗: 2 weeks

Brachial Index according to the smoking history

次要结局

  • Brachial Index(2 weeks)

研究者

发起方
Masih Daneshvari Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

babak sharif kashani

Head of Cardiology Department

Masih Daneshvari Hospital

研究点 (1)

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