Status:
UNKNOWN
Trial of Oral Melatonin in Elevated Blood Pressure
Lead Sponsor:
Tehran University of Medical Sciences
Conditions:
Elevated Blood Pressure
Eligibility:
All Genders
30-60 years
Phase:
PHASE3
Brief Summary
Since, lowering blood pressure (BP) in elevated blood pressure individuals represents an excellent opportunity to for primary prevention of hypertension (HTN). Therefore, it is planned to use a safe t...
Detailed Description
Study design: Randomized controlled trial (RCT) Study population: Elevated blood pressure individuals who present themselves at the outpatient clinics of Tehran Heart Centre(THC) , seeking blood pres...
Eligibility Criteria
Inclusion
- Individuals with systolic blood pressure120-129 and/or diastolic blood pressure =80mmHg
- Negative pregnancy test for women at productive age
- Baseline melatonin and biomarkers level and complete liver function tests within normal range
Exclusion
- Previous history of hypersensitivity of melatonin
- Past history of using antihypertensive treatment
- Past medical history of hypertension, cardiovascular diseases, (i.e. coronary artery disease), and diabetes mellitus, epilepsy and other physician documented diseases
- Use of beta-blockers, sleep aids, warfarin, flaxseed, soy and supplements
Key Trial Info
Start Date :
June 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT03764020
Start Date
June 1 2019
End Date
December 1 2019
Last Update
April 10 2019
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