Health Condition 1: null- Essential Hypertension
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosed patients of essential hypertension S.B.P. >= 140 Hg. and_ = 90 Hg. and _ 2. Willing and able to participate for 14 weeks
Exclusion criteria
Exclusion criteria: 1. Known clinical diagnosed cases of coronary diseases 2. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months. 3. Symptomatic patients with clinical evidence of Heart failure. 4. Secondary hypertension. 5 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. 6.Patients with Diabetes Mellitus {B.S. (F) > 126 mg/dl and / or B.S. (2 hr. PP) >200 mg/dl} 7. Women who are pregnant or lactating. 8. Patients on steroids, oral contraceptive pills or estrogen replacement therapy. 9. Alcoholics and/or drug abusers. 10.Serum Triglycerides >= 250 mg/dl 11.Patients with evidence of malignancy 12. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.) 13. H/o hypersensitivity to any of the trial drugs or their ingredients. 14. Patients who have completed participation in any other clinical trial during the past six (06) months. 15. Any other condition which the Investigator 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, 14, 28, 42,56,70,84 and at the end of follow up after 14 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in the SF-36-Health Survey Score. 2.Change in Hamilton Anxiety Rating Scale (HAM â?? A) Score Timepoint: 1. At baseline, 84 and at the end of follow up after 14 weeks. 2. At baseline, 14, 28, 42,56,70,84 days and at the end of follow up after 14 weeks. | — |
Countries
India
Contacts
Ayurveda Regional Research Institute, Patna