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

Early Phase 1

• Conditions: Coronary Heart Disease
• Interventions: Drug: L-Citrulline malate

• Registration Number: NCT01917123
• Lead Sponsor: Masih Daneshvari Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-07
• Study Start: 2013-08
• Study First Submitted: 2013-08-03
• Study First Submitted QC: 2013-08-03
• Last Update Submitted: 2013-08-03
• Study First Posted: 2013-08-06
• Last Update Posted: 2013-08-06
• Primary Completion: 2014-03
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stimol, Brachial Index, Powder agent	L-Citrulline malate	L-Citrulline malate,1gr,twice a day,2weeks

Primary Outcome Measures

Name	Time	Method
Brachial Index	2 weeks	Brachial Index according to the smoking history

Secondary Outcome Measures

Name	Time	Method
Brachial Index	2 weeks	Brachial Index according to coronary heart disease

Trial Locations

Locations (1)

National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Masih Daneshvari Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of