CTRI/2021/05/033481RecruitingNot Applicable
A Clinical Study on the Management of Essential Hypertension Grade 2 (Zaghtuddam Qawi Ibtidai- Darja Doem)with A Polyherbal Unani Formulation, A Randomized Standard Controlled Clinical Trial
Prof Rais Ur Rahman1 site in 1 country60 target enrollmentStarted: May 25, 2021Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- To develop safe efficacious and cost effective drug for the management of Essential hypertension from herbal source
Study Overview
Brief Summary
Keeping view of higher prevalence of hypertension in India this trial is aimed for controlling blood pressure of such diagnosed Grade 2 essential hypertensive patient. It would be an randomized standard controlled study with a sample size of 60 patients.30 patients will be subjected to test drug ( Unani polyherbal formulation) and rest will be subjected to a allopathic medicine which is Telmisartan. Patient would be assessed weekly on the set parameters. Total duration of the protocol therapy would be 21 days
Study Design
- Study Type
- Interventional
- Allocation
- Permuted block randomization, fixed
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Diagnosed patients of either sex with age limit from 18 years to 65 years with Essential Hypertension Grade 2 as per ACC criteria Patient willing to participate and sign the informed understood consent form.
Exclusion Criteria
- •Secondary hypertension Patient with sign of end organ damage Patient taking OCP and long term use of steroids Pregnant & lactating women Renal and hepatic insufficiency other Cardiovascular disorder malignancy Patient who unwilling to sign the consent form.
Outcomes
Primary Outcomes
To develop safe efficacious and cost effective drug for the management of Essential hypertension from herbal source
Time Frame: baseline | 7th day | 14th day | 21st day
Secondary Outcomes
- Expected Blood pressure target to achieve around 120/80 mm Hg plus minus 10 mm Hg during mental & physical rest(7 th day)
Investigators
Study Sites (1)
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