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

Coronary Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01917123
• Other study ID #: f-91-128
• Status: Not yet recruiting
• Phase: Phase 0
• First received: August 3, 2013
• Last updated: August 3, 2013
• Start date: August 2013
• Est. completion date: March 2014

Study information

• Verified date: July 2013
• Source: Masih Daneshvari Hospital
• Contact: Babak Sharif-Kashani, cardiologist
• Phone: 0098-021-88883114
• Email: sharifk[@]nritld.ac.ir
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Drug:
• L-Citrulline malate
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

Locations

Country	Name	City	State
Iran, Islamic Republic of	National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Masih Daneshvari Hospital	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
Masih Daneshvari Hospital	hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brachial Index	Brachial Index according to the smoking history	2 weeks	No
Secondary	Brachial Index	Brachial Index according to coronary heart disease	2 weeks	No