The Effect of L-Citrulline Malate on Ankle Brachial Index Among Patients With Coronary Heart Disease

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Drug: L-Citrulline malate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stimol, Brachial Index, Powder agent<br>L-Citrulline malate,1gr,twice a day,2weeks | Drug: L-Citrulline malate<br>* L-Citrulline malate as a 1gr powder agent, twice a day, for 2 weeks and placebo as a 1gr powder agent of O.R.S, twice a day,for 2 weeks<br>* Other names: Stimol;|
| Placebo Comparator: Placebo, Brachial Index, Powder agent<br>Placebo,1gr,twice a day,2weeks | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brachial Index | Brachial Index according to the smoking history | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brachial Index | Brachial Index according to coronary heart disease | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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L-Citrulline malate,Coronary Heart Disease, Brachial Index