CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF “HYPERCUM” IN HYPERTENSION AND ASSOCIATED QUALITY OF LIFE - AN OPEN LABELED PROOF OF CONCEPT STUDY
DOI:
https://doi.org/10.70066/jahm.v2i4.170Keywords:
Hypercum, Hypertension, Blood pressure, co-morbid conditionsAbstract
Background: High blood pressure has emerged as a leading cause for death and disability worldwide. Management of
hypertension effectively has been a distant reality. Hypercum, a rationale combination of herbs has shown to reduce BP
effectively along with other benefits as studied in the ancient literatures and research publication. Objectives: The aim
of the study is to evaluate the safety and efficacy of “Hypercum” on mild to moderate hypertension, associated with comorbid
conditions. Methods: An open labeled nonrandomized proof of concept study enrolled 16 hypertensive
patients, who met the selection criteria. The efficacy was assessed by measuring the blood pressure at baseline and on
every 15 days till the BP got controlled and then every month and followed up for 84 days. The effect of Hypercum on
other co-morbid conditions was also evaluated. The quality of life was also assessed using SF-30. Planned student‘t’
test was applied. Results: At screening (before the enrollment for the study) the mean systolic blood pressure (SBP)
was 161.25 mmHg and their mean diastolic blood pressure (DBP) was 106.88mmHg. The mean baseline systolic blood
pressure, the mean diastolic blood pressure and the mean arterial blood pressure (MAP) were 152.50 mmHg, 99 mmHg
and 113.88 mmHg respectively. The mean value of these parameters SBP, DBP and MAP decreased to 122.50 mmHg,
81.67 mmHg and 92.58 mmHg respectively at visit 5 that is at Day 84. There was significant reduction in systolic
blood pressure, diastolic blood pressure and mean arterial blood pressure from baseline to the entire visit that is Day14,
Day28, Day56 and Day84. Conclusion: “Hypercum” is effective in treating the mild to moderate hypertension
associated with co-morbid conditions with positive outcome on the quality of life.
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