Melatonin in elevated blood pressure

A triple blinded randomized controlled trial of oral Melatonin in elevated blood pressure individuals

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20181003041218N2

Enrollment

320

Registered

2019-01-05

Start date

2018-12-22

Completion date

Unknown

Last updated

2019-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elevated blood pressure. Secondary hypertension

Interventions

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. M

Eligibility

Sex/Gender

All

Age

30 Years to 60 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Secondary

Measure	Time frame
?Change in sleep quality score. Timepoint: Before intervention and 3 weeks later. Method of measurement: Pittsburg Sleep Quality inventory.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Zinat Hatmi

Tehran University of Medical Sciences

znhatmi@yahoo.com+98 21 6405 3220

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026