A Prospective, Randomized, Three Arm, Open Label, Parallel Group, Multicentric Study to Evaluate the Effectiveness of Supplementing MG-HTÂ® in Reduction of Blood Pressure in Subjects with Stage I â?? Stage II Hypertension on any Anti-Hypertensive Therapy.

Pharmed Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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

发起方

Pharmed Limited