A randomized, double-blind, clinical study to assess safety and efficacy of polyherbal formulation in mild to moderate hypertension
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- PALS Limited
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Assessment of changes in systolic and diastolic blood pressure
Overview
Brief Summary
It will be a 12-week interventional study with 60 participants with stage 1 essential hypertension. The participants will be randomly assigned equally in two arms. One group will receive Brahmi vati in capsule form, while the other group will receive a test drug. The efficacy and safety of both treatments will be compared. Efficacy will be evaluated based on the percentage of subjects achieving B.P. less than 140/90 mm of Hg, as well as changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) from baseline to the end of the12 weeks. Safety will be assessed by recording lab values of RFT, and adverse events from the baseline to the end of the 12-week study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Stage 1 Essential hypertension (average automated systolic blood pressure of 140 to 160 mmHg or diastolic blood pressure of 90 to 100 mm of Hg acc.
- •to JNC VIII)
- •18 to 65-years-old Male or female and able to provide informed consent.
Exclusion Criteria
- •Atrial Fibrillation (AF)/ Sick Sinus Syndrome (SSS)/ atrioventricular block 2-3 grade without pacemaker.
- •Bradyarrhythmia
- •Unstable Angina Pectoris (UAP)/AMI/ HF (NYHA class III.
- •Uncontrolled diabetes mellitus (DM)
- •Gastro-intestinal ulcer
- •Liver dysfunction/ renal impairment
- •Treated with CCB (Calcium antagonists) or another beta blocker.
- •Pregnant or lactating women
- •Legal incapacity or limited legal capacity.
Outcomes
Primary Outcomes
Assessment of changes in systolic and diastolic blood pressure
Time Frame: Baseline to 12 weeks
Secondary Outcomes
- Change in eGFR (estimated glomerular filtration rate).(baseline to 12 weeks.)
- Assessment of change in anthropometric parameters like BMI, BMR, Waist and hip circumference.(baseline to 12 weeks.)
- Assessment of change in improvement in quality of life health survey score(baseline to 12 weeks.)
- The safety of the intervention will be assessed by evaluating:(Laboratory parameters of renal function test.)
- Adverse events profile from baseline to end of the study.(baseline to 12 weeks.)
- Compliance and tolerability of the investigational product throughout the study(baseline to 12 weeks)
Investigators
Dr Kshipra Rajoria
National Institute of Ayurveda Jaipur