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

NCT ID: NCT01917123

Last Updated: 2013-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-03-31

Brief Summary

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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

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Conditions

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Coronary Heart Disease

Keywords

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L-Citrulline malate,Coronary Heart Disease, Brachial Index

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stimol, Brachial Index, Powder agent

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

Group Type ACTIVE_COMPARATOR

L-Citrulline malate

Intervention Type DRUG

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

Placebo, Brachial Index, Powder agent

Placebo,1gr,twice a day,2weeks

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Stimol

Eligibility Criteria

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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)
Minimum Eligible Age

16 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role collaborator

Masih Daneshvari Hospital

OTHER

Sponsor Role lead

Responsible Party

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babak sharif kashani

Head of Cardiology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Babak Sharif-Kashani, Cardiologist

Role: STUDY_DIRECTOR

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

Shabnam Eslam-Panah, M.D

Role: PRINCIPAL_INVESTIGATOR

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

Paritash Tahmaseb-pour, M.D

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

Central Contacts

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Babak Sharif-Kashani, cardiologist

Role: CONTACT

Phone: 0098-021-88883114

Email: [email protected]

Paritash Tahmaseb-pour, M.D

Role: CONTACT

Phone: 0098-09125037861

Email: [email protected]

Facility Contacts

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Babak Sharif-Kashani, Cardiologist

Role: primary

Paritash Tahmaseb-pour, M.D

Role: backup

Other Identifiers

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f-91-128

Identifier Type: -

Identifier Source: org_study_id