To evaluate Efficacy and safety of LevodynTM in subjects with mild hypertensio
- Conditions
- Health Condition 1: null- Mild Hypertension
- Registration Number
- CTRI/2011/09/002028
- Lead Sponsor
- athan naturalLLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Male or Female adult aged 30-55 years.
Stage 1 Hypertension as defined by systolic blood pressure (SBP)140-159 or diastolic blood pressure (DBP) 90-99 mm og Hg(measured accurately on two separate visit at least one week apart and within two months,in appropriately prepared and positioned patients) not receiving any anti-hypertensive medications)
?Patients classified as normal, prehypertensive and stage II hypertensive
?Hypertension due to identifiable causes such as chronic kidney disease, thyroid disease, coarctation of the aorta, cushing?s syndrome, drug induced or drug related causes etc
?Evidence of cardiovascular disease including heart failure
?Uncontrolled diabetes mellitus (FBS110 mg/dl) or subjects controlled on glitazones (thiazolidinediones)
?Dyslipidemia as evidenced by reports of elevated LDL170mg/dL OR total cholesterol250mg/dL, OR low HDL cholesterol (40mg/dL in men and 50mg/dL in women), Triglycerides 150 mg/dL within the last 3 months
?Patients receiving treatment for dyslipidemia
?Family history of premature CVD (men 55 years of age or women 65 years of age)
?Impaired renal function as evidenced by Serum creatinine 1.5 mg/dl within the last 1 month
?Known cases of microalbuminuria
?Known or suspected cases of bleeding disorders
?Patients requiring therapy with warfarin, aspirin or other anti-platelet agents
?BMI 30 kg/m2
?Tobacco usage, particularly cigarettes10 / day
?Heavy alcohol consumption
?Pregnant, lactating women; women of reproductive age not practicing contraception
?Significant (as assessed by the investigator) pulmonary, metabolic, renal, hepatic disease, or malignancy, interfering with subjects participation in this study.
?Participation in a clinical trial within 3 months prior to screening
?Subjects who have received any treatment or any traditional medicine / Homeopathic /naturopathy medicine or any other therapy for reducing blood pressure, within the last 1 month
?Any condition necessitating the use of a medication known to affect the blood pressure levels (e.g. antidepressants, statins, NSAIDs, decongestants etc.)
?Any condition, which in the opinion of the investigator, might interfere with the subject?s participation / compliance to the protocol or the outcome of the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method