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

Primary Purpose

Coronary Heart Disease

Status

Unknown status

Phase

Early Phase 1

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

L-Citrulline malate

About this trial

This is an interventional treatment trial for Coronary Heart Disease focused on measuring L-Citrulline malate,Coronary Heart Disease, Brachial Index

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Masih Daneshvari Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Stimol, Brachial Index, Powder agent

Placebo, Brachial Index, Powder agent

Arm Description

L-Citrulline malate,1gr,twice a day,2weeks

Placebo,1gr,twice a day,2weeks

Outcomes

Primary Outcome Measures

Brachial Index

Brachial Index according to the smoking history

Secondary Outcome Measures

Brachial Index

Brachial Index according to coronary heart disease

Full Information

NCT ID

NCT01917123

First Posted

August 3, 2013

Last Updated

August 3, 2013

Sponsor

Masih Daneshvari Hospital

Collaborators

Shahid Beheshti University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01917123

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Unknown status

Study Start Date

August 2013 (undefined)

Primary Completion Date

March 2014 (Anticipated)

Study Completion Date

March 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Masih Daneshvari Hospital

Collaborators

Shahid Beheshti University of Medical Sciences

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Heart Disease

Keywords

L-Citrulline malate,Coronary Heart Disease, Brachial Index

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Stimol, Brachial Index, Powder agent

Arm Type

Active Comparator

Arm Description

L-Citrulline malate,1gr,twice a day,2weeks

Arm Title

Placebo, Brachial Index, Powder agent

Arm Type

Placebo Comparator

Arm Description

Placebo,1gr,twice a day,2weeks

Intervention Type

Drug

Intervention Name(s)

L-Citrulline malate

Other Intervention Name(s)

Stimol

Intervention Description

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

Primary Outcome Measure Information:

Title

Brachial Index

Description

Brachial Index according to the smoking history

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

Brachial Index

Description

Brachial Index according to coronary heart disease

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Babak Sharif-Kashani, cardiologist

Phone

0098-021-88883114

sharifk@nritld.ac.ir

First Name & Middle Initial & Last Name or Official Title & Degree

Paritash Tahmaseb-pour, M.D

Phone

0098-09125037861

paritash_t@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Babak Sharif-Kashani, Cardiologist

Organizational Affiliation

Lung Transplantation Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Shabnam Eslam-Panah, M.D

Organizational Affiliation

Lung Transplantation Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Paritash Tahmaseb-pour, M.D

Organizational Affiliation

Lung Transplantation Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Masih Daneshvari Hospital

City

Tehran

ZIP/Postal Code

021

Country

Iran, Islamic Republic of

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Babak Sharif-Kashani, Cardiologist

Phone

0098-021-88883114

sharifk@nritld.ac.ir

First Name & Middle Initial & Last Name & Degree

Paritash Tahmaseb-pour, M.D

Phone

0098-09125037861

paritash_t@yahoo.com

First Name & Middle Initial & Last Name & Degree

Babak har Sharif-Kashani, Cardiologist

First Name & Middle Initial & Last Name & Degree

Shabnam Eslam-Panah, M.D

First Name & Middle Initial & Last Name & Degree

Paritash Tahmaseb-pour, M.D

12. IPD Sharing Statement

Learn more about this trial

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

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