]>
IRCT20181126041757N1 IRCT 2019-04-18 Tehran University of Medical Sciences Evaluation of the effectiveness of L-citrulline plus nCPAP versus solitary nCPAP in improvement of endothelium dysfunction and decreasing the severity of obstructive sleep apnea evaluation of the effectiveness of L-citrulline plus nCPAP versus solitary nCPAP in improvement of endothelium dysfunction and decreasing the severity of obstructive sleep apnea in patients undergoing polysomnography in Baharloo hospital and are categoriazed as moderate to serevere OSA 2019-05-05 anticipated 42 Complete https://irct.ir/trial/37262 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: We divide patients into two groups by permuted block randomization. Since diabetes status of patients can be as an important covariate which affects the outcome, we control it by stratification approach. By using https://www.sealedenvelope.com we are going to make 2 randomized group in the basis of their diabet status and only one person is going to be aware of our allocation concealment . The investigator get in touch with that person each time that we have a new participant and ask which of the groups should the participant get involved with and for each drug box we have a number on it which is assigned randomely, Blinding description: Usage of placebo for the patient and assign each patient with a code for radiologist blindness and allocating numbers to each box of drugs. 3 Obstructive sleep apnea/L-citruline effect on artery. Intervention 1: Intervention group: patients are divided into 2 groups by block randomization and by stratification protocol we try that the diabetes dispersion be the same in both groups. For our intervention group we prescribe stimol biocodex which contains 1gr citrulline malate with the following schedule: for the first 10 days,TDS and for the next 20 days, BD. During this 1 month, patients have to utilize CPAP for 4 hours each night. After this 1 month we assess patients from the point of AHI, FMD/NMD by using colour doppler ultrasonography and then we compare data from the begginig to end of our trial. Intervention 2: Control group: cpap therapy for 1 month, 4 hours each night and placebo which is prescribe TDS for the first 10 days and BD for the next 20 days. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Due to the Impact Factor of different journals and their scheduling, they still have not decided to publish an entire publication.
public Saeed Nateghi
Abu Zar Street lower than Abuzar Square, Ziaian Hospital
Tehran Iran (Islamic Republic of) 1366736511 +98 21 5517 6031 snateghi@sina.tums.ac.ir Tehran University of Medical Sciences scientific Saeed Nateghi
Abu Zar Street lower than Abuzar Square, Ziaian Hospital
Tehran Iran (Islamic Republic of) 1366736511 +98 21 5517 6031 snateghi@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients who are categorized as moderate to severe according to AHI criteria by using polysomnography The ones that clinical ultrasonography proves that the patient has endothelial dysfunction (FMD> NMD) Patients the their arterial muscular dysfunction has been ruled out no limit no limit Both If less than 40 days have been passed from patien's OSA treatment Hx of coronary artery disease (>50% of arterial occlusion, or any background PCI or CBAG) Ischemic heart disease Smoking Patients who do not have endothelial dysfunction (FMD ratio to normal vessel diameter is more than one) Receiving any medication that affects endothelial function unless 4 half-life of the drug has been passed since its last consume. G47.33 Obstructive sleep apnea (adult) (pediatric) Treatment - Drugs Placebo Intervention group: patients are divided into 2 groups by block randomization and by stratification protocol we try that the diabetes dispersion be the same in both groups. For our intervention group we prescribe stimol biocodex which contains 1gr citrulline malate with the following schedule: for the first 10 days,TDS and for the next 20 days, BD. During this 1 month, patients have to utilize CPAP for 4 hours each night. After this 1 month we assess patients from the point of AHI, FMD/NMD by using colour doppler ultrasonography and then we compare data from the begginig to end of our trial. Control group: cpap therapy for 1 month, 4 hours each night and placebo which is prescribe TDS for the first 10 days and BD for the next 20 days Brachial artery diameter. Timepoint: The beginning and the end of the study. Method of measurement: colour doppler ultrasound. Daily sleepiness. Timepoint: at the beginning and the end of the study. Method of measurement: Epworth sleepness scale questionnaire. Depression rate. Timepoint: The beginning and the end of the study. Method of measurement: patients health questionnaire-9. Dislipidemia. Timepoint: The beginning and the end of the study. Method of measurement: Patient case. Tehran University of Medical Sciences Approved 2018-11-28 National Ethics Committee for Biomedical Research Building of Tehran University of Medical Sciences, Qods St. Tehran Tehran Iran (Islamic Republic of)