Health Condition 1: null- Essential Hypertension
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either sex aged 18 years and above. 2. Diagnosed patients of essential hypertension with: S.B.P. = 140 mm Hg. D.B.P. 90 mm. Hg (Hypertension Stage â??1, as per JNC VII report, 2004) 3. Willing and able to participate for 16 weeks
Exclusion criteria
Exclusion criteria: 1. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months. 2. Symptomatic patients with clinical evidence of Heart failure. 3. Secondary hypertension. 4. Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT > 3 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > 1.2mg/dl),uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease. 5. Patients with Diabetes Mellitus {B.S. (F) > 126 mg% and / or B.S. (2 hr. PP) >200 mg% OR HbA1c > 6.5%} 6. Women who are pregnant or lactating. 7. Patients on steroids, oral contraceptive pills or estrogen replacement therapy. 8. Alcoholics and/or drug abusers. 9. Serum Triglycerides >= 250 mg/dl 10. Patients with evidence of malignancy 11. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.) 12. H/o hypersensitivity to any of the trial drugs or their ingredients. 13. Patients who have completed participation in any other clinical trial during the past six (06) months. 14. Any other condition which the P.I. thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline measurements in mean sitting systolic blood pressure and mean sitting diastolic blood pressure.Timepoint: at Baseline, 14th day, 28th day, 42nd day, 56th day, 70th day, 84th day and at the end of follow up after 16 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Change in the SF-36-Health Survey Score. â?¢ Change in Hamilton Anxiety Rating Scale (HAM â?? A) Score.Timepoint: SF-36 Survey Score-Baseline, 84th day and at the end of follow up after 16 weeks. HAM-A score-at Baseline, 14th day, 28th day, 42nd day, 56th day, 70th day, 84th day and at the end of follow up after 16 weeks. | — |
Countries
India
Contacts
Central Council for Research in Ayurvedic Sciences (CCRAS)