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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2013 by Masih Daneshvari Hospital
Sponsor:
Collaborator:
Shahid Beheshti Medical University
Information provided by (Responsible Party):
babak sharif kashani, Masih Daneshvari Hospital
ClinicalTrials.gov Identifier:
NCT01917123
First received: August 3, 2013
Last updated: NA
Last verified: July 2013
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Coronary Heart Disease
Drug: L-Citrulline malate
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Masih Daneshvari Hospital:

Primary Outcome Measures:
  • Brachial Index [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Brachial Index according to the smoking history


Secondary Outcome Measures:
  • Brachial Index [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Brachial Index according to coronary heart disease


Estimated Enrollment: 20
Study Start Date: August 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Stimol, Brachial Index, Powder agent
L-Citrulline malate,1gr,twice a day,2weeks
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
Other Name: Stimol
Placebo Comparator: Placebo, Brachial Index, Powder agent
Placebo,1gr,twice a day,2weeks

  Eligibility

Ages Eligible for Study:   16 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01917123

Contacts
Contact: Babak Sharif-Kashani, cardiologist 0098-021-88883114 sharifk@nritld.ac.ir
Contact: Paritash Tahmaseb-pour, M.D 0098-09125037861 paritash_t@yahoo.com

Locations
Iran, Islamic Republic of
National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Masih Daneshvari Hospital Not yet recruiting
Tehran, Iran, Islamic Republic of, 021
Contact: Babak Sharif-Kashani, Cardiologist    0098-021-88883114    sharifk@nritld.ac.ir   
Contact: Paritash Tahmaseb-pour, M.D    0098-09125037861    paritash_t@yahoo.com   
Principal Investigator: Babak har Sharif-Kashani, Cardiologist         
Principal Investigator: Shabnam Eslam-Panah, M.D         
Principal Investigator: Paritash Tahmaseb-pour, M.D         
Sponsors and Collaborators
Masih Daneshvari Hospital
Shahid Beheshti Medical University
Investigators
Study Director: Babak Sharif-Kashani, Cardiologist Lung Transplantation Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran
Principal Investigator: Shabnam Eslam-Panah, M.D Lung Transplantation Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran
Principal Investigator: Paritash Tahmaseb-pour, M.D Lung Transplantation Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran
  More Information

No publications provided

Responsible Party: babak sharif kashani, Head of Cardiology Department, Masih Daneshvari Hospital
ClinicalTrials.gov Identifier: NCT01917123     History of Changes
Other Study ID Numbers: f-91-128
Study First Received: August 3, 2013
Last Updated: August 3, 2013
Health Authority: Iran: Ethics Committee

Keywords provided by Masih Daneshvari Hospital:
L-Citrulline malate,Coronary Heart Disease, Brachial Index

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Heart Diseases
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014