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IRCT20181003041218N2 IRCT 2019-01-05 Tehran University of Medical Sciences Melatonin in elevated blood pressure A triple blinded randomized controlled trial of oral Melatonin in elevated blood pressure individuals 2018-12-22 anticipated 320 Complete https://irct.ir/trial/34267 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Balanced randomization by using random blocks. Unit of randomization: Individual patients Randomization tool: Sealed envelope containing intervention group By using random block tables, 80 blocks of 4 members according to a total of 320 sample size will be chosen. Within each block there will be 2 interventions and 2 placebos. Permutations will be random and allocation to the study groups will be applied by using sealed envelope. Allocation concealment: Randomization will be assigned at the central office of design and performance of the trial. Patients and medical providers will be unaware of the randomization scheme and study groups, Blinding description: Triple blinding is planned. All participants, health care, data collectors and outcome assessors will be blinded about treatment arms. Data analyzer and person who is responsible for project monitoring will also be blinded. Blinding and assignment of interventional groups will be performed at central office of the trial and health care providers and outcome evaluators will be all blinded about the process. A Concealment envelope will assign patients to intervention group according to random block table. Melatonin and placebo capsule will be identical for keeping patients and medical providers blinded. 3 Elevated blood pressure. Intervention 1: Intervention group:Melatonin 3 mg oral capsule once one hour before bedtime for three weeks along with lifestyle intervention according to 2013 American heart association guideline. Melatonin capsules will made in Iran. Intervention 2: Control group: oral placebo capsule once one hour before bedtime for three weeks along with lifestyle interventionaccording to 2013 American heart association guideline. Placebo capsules will made in Iran. 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 Matter of security regarding patients data
public Dr Zinat Hatmi
Second floor, Building Number 4, Purcina Ave, Keshavarz Bulevard, Tehran, Iran
Tehran Iran (Islamic Republic of) 1417613151 +98 21 6405 3220 znhatmi@yahoo.com Tehran University of Medical Sciences scientific Dr Zinat Hatmi
Second floor, Building Number 4, Purcina Ave, Keshavarz Bulevard, Tehran, Iran
Tehran Iran (Islamic Republic of) 1417613151 +98 21 6405 3220 znhatmi@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Systolic blood pressure 120-129 Diastolic blood pressure =80 mm Hg Age range of 30-60 years Negative pregnancy test for women at productive age Baseline Melatonin and biomarkers level and complete liver function tests within normal range 30 years 60 years Both Past history of using antihypertensive treatment Past medical history of hypertension, cardiovascular diseases, (i.e. coronary artery disease), and diabetes mellitus, epilepsy Use of beta-blockers, sleep aids, warfarin, flaxseed and soy supplements Previous history of hypersensitivity of melatonin I15 Secondary hypertension Prevention Placebo Intervention group:Melatonin 3 mg oral capsule once one hour before bedtime for three weeks along with lifestyle intervention according to 2013 American heart association guideline. Melatonin capsules will made in Iran. Control group: oral placebo capsule once one hour before bedtime for three weeks along with lifestyle interventionaccording to 2013 American heart association guideline. Placebo capsules will made in Iran. Mean of systolic blood pressure change in mm Hg from baseline. Timepoint: Before intervention and 3 weeks later. Method of measurement: In clinic with standardized sphygmomanometer. Mean of diastolic blood pressure change in mm Hg from baseline. Timepoint: Before intervention and 3 weeks later. Method of measurement: In clinic with standardized sphygmomanometer. Mean cholesterol change in mg/dl from baseline. Timepoint: Before intervention and 3 weeks later. Method of measurement: Enzymatic laboratory method. Mean low density lipoprotein change in mg/dl from baseline. Timepoint: Before intervention and 3 weeks later. Method of measurement: Enzymatic laboratory method. Mean high sensitive CRP change in mg/l from baseline. Timepoint: Before intervention and 3 weeks later. Method of measurement: Laboratory method. ُChange in sleep quality score. Timepoint: Before intervention and 3 weeks later. Method of measurement: Pittsburg Sleep Quality inventory. Tehran University of Medical Sciences Approved 2018-09-17 Ethics committee of Tehran University of Medical Sciences Second floor, Building Number 1, Purcina Ave., Keshavarz Bulevard, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)