Coronary Heart DiseaseEarly Phase 1NCT01917123
The Effect of L-Citrulline Malate on Ankle Brachial Index Among Patients With Coronary Heart Disease
A Early Phase 1 study testing L-Citrulline malate in people with Coronary Heart Disease, run by Masih Daneshvari Hospital at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- L-Citrulline malate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIran
- Study dates
- Aug 2013to Mar 2014
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Iran1 site
National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Masih Daneshvari Hospital
Tehran, Tehran Province, 021
Babak Sharif-Kashani, Cardiologist, 0098-021-88883114, sharifk@nritld.ac.ir
Paritash Tahmaseb-pour, M.D, 0098-09125037861, paritash_t@yahoo.com
About this study
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
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.
- Conditions
- Coronary Heart Disease
- Being tested
- L-Citrulline malate
- Keywords
- L-Citrulline malate,Coronary Heart Disease, Brachial Index
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-Citrulline malateDrug
Also called Stimol
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
| Study group | Role | What they receive |
|---|---|---|
| Stimol, Brachial Index, Powder agent | Active comparator | L-Citrulline malate,1gr,twice a day,2weeks Receives: Drug: L-Citrulline malate |
| Placebo, Brachial Index, Powder agent | Placebo comparator | Placebo,1gr,twice a day,2weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial Index
Brachial Index according to the smoking history
Measured: 2 weeks
Secondary outcomes (1)
Brachial Index
Brachial Index according to coronary heart disease
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionMar 2014 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masih Daneshvari Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shahid Beheshti University of Medical Sciences
- Responsible party
- Principal investigator, babak sharif kashani, Masih Daneshvari Hospital
- Investigators
- Babak Sharif-Kashani, Cardiologist, Study director, Lung Transplantation Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, IranShabnam Eslam-Panah, M.D, Principal investigator, Lung Transplantation Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, IranParitash Tahmaseb-pour, M.D, Principal investigator, Lung Transplantation Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917123
- Sponsor's protocol ID
- f-91-128
- Status last verified
- Jul 2013
- First submitted
- 3 Aug 2013
- Last updated
- 6 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01917123
- Acronym / sponsor ID
- f-91-128
- Conditions
- Coronary Heart Disease
- Keywords
- L-Citrulline malate,Coronary Heart Disease, Brachial Index
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Masih Daneshvari HospitalUniversity, hospital or other
- Collaborators
- Shahid Beheshti University of Medical Sciences
- Study start
- Aug 2013
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 6 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stimol, Brachial Index, Powder agent | Active comparator | Drug: L-Citrulline malateL-Citrulline malate,1gr,twice a day,2weeks |
| Placebo, Brachial Index, Powder agent | Placebo comparator | –Placebo,1gr,twice a day,2weeks |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-Citrulline malateAlso: StimolL-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 | Drug | Stimol, Brachial Index, Powder agent |
Primary outcome
Brachial Index
Time frame: 2 weeks
Brachial Index according to the smoking history
1 secondary outcome
Brachial Index
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Babak Sharif-Kashani, Cardiologist 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 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 principal investigator
Lung Transplantation Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing L-Citrulline malate in people with Coronary Heart Disease, run by Masih Daneshvari Hospital at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Babak Sharif-Kashani, cardiologist (0098-021-88883114, sharifk@nritld.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brachial Index (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2013.