Health Condition 1: null- Mild Hypertension
Conditions
Interventions
Intervention1: Levodyn,One tablet twice a day, orally for 3 months: Vitamin B1, Vitamin B2, Vitamin B3, Vitamin B6, Vitamin B9, Vitamin B12, VitaminH/7,Vitamin B5,Calcium,Magnesium,Potassium,Herbal bl
Sponsors
Nathan naturalLLC
Eligibility
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: ? 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of LevodynTM as compared to a placebo, in subjects with stage I hypertensionTimepoint: Day7, Day15, Day 30 and Day 60 and Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of subjects achieving normal BP of SBP 140 mm of Hg and/or DBP90 mm of Hg Number of subjects who develop withdrawal criteria of increase in SBP 160 mm Hg and/or DBP 100 mm Hg, (on two separate visits) Investigators Global assessment Adherence to dietary recommendationTimepoint: 1Day (-7)(Screening) ,Day 0 (Baseline),Day7,Day 15,Day 30,Day 60,Day 90 | — |
Countries
India
Contacts
Public ContactMs Sakshi Pawar
Vedic Lifesciences Pvt. Ltd.
Outcome results
None listed