Health Condition 1: I10-I16- Hypertensive diseases
Conditions
Interventions
Intervention1: MGHT (Magnesium Bisglycinate providing Magnesium 70 mg,
L-Carnitine L-Tartrate 500 mg, Niacinamide 8 mg, Pyridoxine Hydrochloride 1 mg, beta-Sitosterol 20 mg) and standard of care: Tabl
Sponsors
Pharmed Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects of both sex in the age group of 35-65 years, with stage 1 and 2 hypertension as defined by the latest JNC 8 hypertension guidelines and on any anti-hypertensive therapy for at least a month 2. Able to provide signed informed consent 3. Subjects willing to adhere to protocol and study requirements during the entire study duration
Exclusion criteria
Exclusion criteria: 1. Subjects with uncontrolled diabetes mellitus in the opinion of the investigator 2. Subjects with history of myocardial infarction within the past 90 days of the start of the study, cardiac failure of class III and IV, Atrioventricular block II or III on ECG 3. Subjects with chronic kidney disease or liver disorder 4. Chronic terminal diseases such as malignancies, anemias and presence of serum electrolyte disturbances (Na, K, Cl), that might indicate an underlying secondary hypertension. 5. Subjects on magnesium supplements equal to or above the study dose of 70 mg, in which case a wash out period of 7 days will be followed prior to enrollment 6. Any other condition which in the opinion of the investigator renders the patient unfit to participate 7. Female subjects who are lactating, pregnant, or planning to conceive during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a) Proportion of subjects with a reduction in SBP and DBP from baseline to study end b) Mean change in systolic blood pressure from baseline to study end c) Mean change in diastolic blood pressure from baseline to study endTimepoint: Baseline (visit 1, day 1) and Study end (visit 6, day 90) | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Mean change in lipid profile from baseline to study end b) Mean change in serum magnesium levels from baseline to study endTimepoint: Visit 1, day 1 and Visit 6, day 90;a) Solicited and unsolicited adverse events in the three arms b) Changes from baseline in the laboratory parameters of renal function test and liver function testTimepoint: Throughout the study period;Proportion of subjects with subclinical magnesium deficiency at baselineTimepoint: Baseline (visit 1, day 1) | — |
Countries
India
Contacts
Public ContactDr Chandrashekhar
Pharmed Limited
Outcome results
None listed