Comparative Study of Efficacy and Safety of Roselle Tablet and Amlodipine in Patients with Mild Hypertension (Clinical Trial Phase II)

Phase 2

• Conditions: Blood pressure, Adverse event and adverse effects.; Roselle, Amlodipine, mild Hypertension

• Registration Number: TCTR20181218003
• Lead Sponsor: Center of Excellence in applied Thai Traddional Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-03-06
• Study Start: 2018-12-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Enrolling by invitation
• Sex: All
• Target Recruitment: 78

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

• 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood pressure change from baseline at 3 month Day0 week4 week8 week12 using sphygmomanometer for evaluate blood pressure

Secondary Outcome Measures

Name	Time	Method
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)