Health Condition 1: I10- Essential (primary) hypertension
Conditions
Interventions
Intervention1: Tablet Melatonin: Dose: 5mg tablet
Frequency: Once per day at Bedtime.
Route of Administration : Oral
Duration: 6 Months
Control Intervention1: Placebo: Placebo 1 tab Bedtime
Frequency
Sponsors
Centre for integrative Medicine and Research
Eligibility
Inclusion criteria
Inclusion criteria: Patients diagnosed with Hypertension. On stable antihypertensive medication for 6 weeks before trial enrollment. Non-dipping Blood pressure profile (>= 10% dipping of blood pressure at night in comparison of day on mean arterial blood pressure): On Ambulatory blood pressure monitoring.
Exclusion criteria
Exclusion criteria: Patients with accelerated hypertension (Stage III). Patients with secondary hypertension: Renal disease, Endocrinopathies. Patients with history of target organ damage (Nephropathy, Retinopathy). Patients with other cardiac disorders Example: Heart failure (EF Major Stroke or recent stroke. Patients on the drug interacting with Melatonin. Circadian rhythm sleep wake disorders (DSPS, ASPS, Shift workers) No acute coronary syndrome (PCI and CABg) with in 3 Month. Major depressive disorder on medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Establishment of dipping pattern (10% reduction in nocturnal blood pressure from than daytime) of blood pressure on ambulatory blood pressure monitoring.Timepoint: At 3 Months and 6 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare re-establishment of dipping between melatonin and placebo according to prakriti type. Improvement in sleep qualityTimepoint: 6 months | — |
Countries
India
Contacts
Public ContactDr Gautam Sharma
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed