CLINICALTRIAL OF POLY HERBAL PRODUCT IN THE TREATMENT OF HYPERTENSIONAbstract
Background: High blood pressure has emerged as a leading cause of death and disability worldwide.1 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 literature and research publication. Objectives: The study aims to evaluate the safety and efficacy of “Hypercum” on mild to moderate hypertension, an open-labeled nonrandomized proof of concept study enrolled 16hypertensive associated with co-morbid conditions. Methods: 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 106.88 mmHg. 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 a significant reduction in systolic blood pressure, diastolic blood pressure, and mean arterial blood pressure from baseline to the entire visit that is Day 14, Day 28, Day 56, and Day 84. Conclusion: “Hypercum” is effective in treating the mild to moderate hypertension associated with co-morbid conditions with a positive outcome on the quality of life.
S. Harshika, K. Vuppala and A. K. Sharma
Clinical Research Pvt. Ltd., 16 # ICBio Tower, Yelahanka, Chikkabetahali Vidyaranyapura, Banglore, Karnataka, India.
15 March 2014
19 May 2014
28 June 2014
01 September 2014