A clinical study to see the effect of some Ayurvedic formulations in the patients of High Blood Pressure

Phase 2

• Conditions: Health Condition 1: null- Essential Hypertension

• Registration Number: CTRI/2012/05/002663
• Lead Sponsor: Department of AYUSH Ministry of Health Family Welfare Government of India

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

1. Patients of either sex aged 18 years and above.

2. Diagnosed patients of essential hypertension with:

S.B.P. < 159 mm. Hg. and >= 140 mm Hg.

D.B.P. <= 99 mm. Hg. and > 90 mm. Hg

(Hypertension Stage â??1, as per JNC VII report, 2004)

3. Willing and able to participate for 16 weeks

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
â?¢ Change in the SF-36-Health Survey Score. <br/ ><br>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. <br/ ><br>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.