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A clinical study to evaluate the effects of some Ayurvedic formulations in the management of High blood pressure.

Phase 2
Conditions
Health Condition 1: null- Essential Hypertension
Registration Number
CTRI/2015/03/005634
Lead Sponsor
Central Council For Research In Ayurvedic Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
76
Inclusion Criteria

1. Diagnosed patients of essential hypertension S.B.P. >= 140 Hg. and_ < 159 Hg.& D.B.P.>= 90 Hg. and _ < 99 Hg mm. Hg (Hypertension Stage-1,as per JNC VII report,2004)

2. Willing and able to participate for 14 weeks

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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