Circulatory System Cardiology
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Participants to be recruited into the study include males and females between the ages of 30 to 65 yrs. Participants must have been clinically diagnosed with a Stage I hypertension per the study protocol. Participants who are able to and willing to return for follow-up and complete the informed consent process or have a guardian who is able to do so on their behalf.
Exclusion criteria
Exclusion criteria: Patients with uncontrolled, high-risk hypertension (SBP=180mm Hg and DBP=110mm Hg) and prehypertensives. Participants with a history of secondary hypertension and any history of suspected secondary hypertension (aortic congestion, hyperaldosteronism, renal artery stenosis, Cushing's disease, chromaffinoma, polycystic renal disease, etc.). Individuals diagnosed with myocardial infarction or heart failure within 6 months of screening; those who have been diagnosed with a cerebrovascular accident (CVA) within 6 months of screening. Patients with renal failure requiring dialysis or those with oedema caused by renal dysfunction. Subjects with uncontrolled diabetes. Patients with severe liver dysfunction or oedema caused by liver disease (cirrhosis); patients with hypothyroidism and proteinuria. Pregnant and nursing mothers Hypertensives on active medications (allopathic or alternative) within the last 8 weeks Acutely ill individuals.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The outcome of interest in this study is a reduction in the diastolic blood pressure (DBP) after the 8-week period post initiation of the treatment. Effectiveness of L. multiflora was defined as a reduction in DBP of = 10.0 mmHg. A definition of partial effectiveness was to be applied when decline in DBP was = 10.0 mmHg but = 5.0 mmHg. No effect was a term applied when DBP was = 5.0 mmHg after the 8-weeks treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| The effect of L. multiflora on systolic blood pressure (SBP) and diastolic blood pressure (DBP) at termination of the trial. The safety of the product, expressed as its effect on haematological, biochemical and urine parameters. Related adverse events and tolerability of the product. | — |
Countries
Ghana
Contacts
University of Cape Coast