NCT01917123

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Aug 2013

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 6, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

August 6, 2013

Status Verified

July 1, 2013

Enrollment Period

7 months

First QC Date

August 3, 2013

Last Update Submit

August 3, 2013

Conditions

Coronary Heart Disease

Keywords

L-Citrulline malate,Coronary Heart Disease, Brachial Index

Outcome Measures

Primary Outcomes (1)

  • Brachial Index

    Brachial Index according to the smoking history

    2 weeks

Secondary Outcomes (1)

  • Brachial Index

    2 weeks

Study Arms (2)

Stimol, Brachial Index, Powder agent

ACTIVE COMPARATOR

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

Drug: L-Citrulline malate

Placebo, Brachial Index, Powder agent

PLACEBO COMPARATOR

Placebo,1gr,twice a day,2weeks

Interventions

L-Citrulline malateDRUG

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

Also known as: Stimol
Stimol, Brachial Index, Powder agent

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Tehran, Tehran Province, 021, Iran

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • 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

    STUDY DIRECTOR

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Babak Sharif-Kashani, cardiologist

CONTACT

0098-021-88883114sharifk@nritld.ac.ir

Paritash Tahmaseb-pour, M.D

CONTACT

0098-09125037861paritash_t@yahoo.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Cardiology Department

Study Record Dates

First Submitted

August 3, 2013

First Posted

August 6, 2013

Study Start

August 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

August 6, 2013

Record last verified: 2013-07

Locations

IR(1)