Hypertension represents a significant global public health challenge, primarily due to its high prevalence and its role as a leading risk factor for cardiovascular diseases (CVD) and other serious health complications. The prevalence of hypertension in Thailand is relatively high compared to other Southeast Asian countries, with an age-standardized prevalence of 25.7% as of 2019-2020. In the broader Southeast Asia region, approximately 35% of the adult population is affected by hypertension, con
Conditions
Interventions
volunteers receive 125 mg of roselle extract twice daily, two capsules per dose, before breakfast and dinner, for a total duration of 12 weeks.,volunteers receive 5 mg of amlodipine once daily, one ta
Experimental Drug,Active Comparator Drug
roselle tablet,amlodipine
Sponsors
National Research Council of Thailand (NRCT)
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Male and female aged 40-70 years. 2. Diagnosed with mild hypertension (systolic 140-159 mmHg, diastolic 90-99 mmHg) by a physician. 3. No severe symptoms or diseases based on medical history, physical examination, and laboratory tests (CBC, FBS, Cholesterol, Triglyceride, HDL-c, LDL-c, Liver function test, Renal function test). 4. Normal Electrocardiogram (EKG) results with no abnormal QT interval, ST segment changes, or pathologic Q wave. 5. Mentally sound and able to speak Thai. 6. Taking no more than one type of antihypertensive medication. 7. Not addicted to any substances. 8. Willing to participate and follow the study instructions. 9. Not currently enrolled in other research projects.
Exclusion criteria
Exclusion criteria: 1. Pregnant, suspected of being pregnant, or breastfeeding. 2. Having chronic diseases such as diabetes, kidney disease, stroke, or heart-related diseases , liver disease , kidney disease , or currently taking medications like phenytoin, propranolol, theophylline, and rifampicin. 3. History of allergy to roselle or amlodipine. 4. Blood pressure systolic more than 160 mmHg or diastolic less than 100 mmHg.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood pressure; Systolic and Diastolic blood pressure At weeks 4, 8, and 12, while receiving medication. Blood pressure was measured using calibrated digital monitors and Case Record form. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Event 12 weeks Adverse Event Form,Laboratory Testing 12 weeks complete blood count (CBC),Laboratory Testing 12 weeks blood sugar (FBS),Laboratory Testing 12 weeks lipid profile ,Laboratory Testing 12 weeks liver function tests ,Laboratory Testing 12 weeks renal function tests ,Laboratory Testing 12 weeks electrolyte,Laboratory Testing 12 weeks urine Na+, Urine K+.. | — |
Countries
Thailand
Contacts
Public ContactWinit Longlalerng
Faculty of Medicine, Thammasat University
Outcome results
None listed