Blood pressure,
Conditions
Interventions
Roselle Tablets 125 mg 2 tablets twice a day,
orally before meal for 12 weeks ,Amlodipine 5 mg tablet once a day for 12 week orally before meal for 12 weeks
Experimental Drug,Active Comparator Drug
Roselle Tablets 125 mg ,Amlodipine 5 mg
Sponsors
Center of Excellence in applied Thai Traddional Medicine
Thammasat University.
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: • Age between 40-70 years • Diagnosed with mild hypertension (systolic 140-159 mmHg, diastolic 90-99 mmHg ) • Never have no received antihypertensive treatment or Ever have received only one type of Antihypertensive drug • Have no received antihypertensive treatment at least for 2 weeks prior to study • Results of Electrocardiogram (EKG) have no abnormal QT interval, ST segment changing and no pathologic Q wave • Must have granted consent for participation in this clinical investigation
Exclusion criteria
Exclusion criteria: • Patient with diabetes, nephropathy, Cardiopathy, hepatic disease and cancer were excluded • Have potassium less than 3.4 mmol/L • Pregnant women, patient with evidence of secondary hypertension, chronic smokers and alcoholics were excluded • Be allergic in Roselle or Amlodipine • Who did not complete the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood pressure change from baseline at 3 month Day0 week4 week8 week12 using sphygmomanometer for evaluate blood pressure | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum Electrolyte change from baseline at 3 month Day0 week4 week8 week12 To evaluate the adverse event by Serum Electrolyte. Which including Na, K, Cl and CO2. Normal range ,Renal funtion change from baseline at 3 month Day0 week4 week8 week12 To evaluate the adverse event by hematology test of renal function which including BUN(mg/dL), creat,Liver Function change from baseline at 3 month Day0 week4 week8 week12 To evaluate the adverse event by hematologytest of liver function which including AST(U/L), ALT(U/L) | — |
Countries
Thailand
Contacts
Public ContactChatjutha Tangkomsaengtong
Faculty of medicine, Thammasat University
Outcome results
None listed