Effects of Magnesium Supplements in Hypertensive patients.
- Conditions
- Health Condition 1: I10-I16- Hypertensive diseases
- Registration Number
- CTRI/2020/01/022864
- Lead Sponsor
- Pharmed Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method a) Proportion of subjects with a reduction in SBP and DBP from baseline to study end <br/ ><br>b) Mean change in systolic blood pressure from baseline to study end <br/ ><br>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 Outcome Measures
Name Time Method a) Mean change in lipid profile from baseline to study end <br/ ><br>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 <br/ ><br>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)