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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2013 by babak sharif kashani, Masih Daneshvari Hospital.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01917123
First Posted: August 6, 2013
Last Update Posted: August 6, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Shahid Beheshti University of Medical Sciences
Information provided by (Responsible Party):
babak sharif kashani, Masih Daneshvari Hospital
  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 Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 babak sharif kashani, Masih Daneshvari Hospital:

Primary Outcome Measures:
  • Brachial Index [ Time Frame: 2 weeks ]
    Brachial Index according to the smoking history


Secondary Outcome Measures:
  • Brachial Index [ Time Frame: 2 weeks ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 University of Medical Sciences
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

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
First Submitted: August 3, 2013
First Posted: August 6, 2013
Last Update Posted: August 6, 2013
Last Verified: July 2013

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

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