CTRI/2025/05/087052Not yet recruitingPhase 1
Randomised Open Controlled Clinical Study to evaluate the effect of Bruhatyadi Vati in management of Medodushti with special reference to Dyslipidema
DrNileshkumar Samarjit Tiwari1 site in 1 country106 target enrollmentStarted: January 7, 2025Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 106
- Locations
- 1
- Primary Endpoint
- Changes in Lipid Profile by Bruhatyadi Vati towards the Normal levels.
Study Overview
Brief Summary
Dyslipidemia is a major risk factor for cardiovascular disease, the leading cause of deaths.
Currently available Hypolipidemic drugs are either expensive or often related to side effects. Hence there has been a pursuit for new safe and effective polyherbal drug for Dyslipidemia.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 25.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Age group having 25 to 60 years of age.
- •Obese Dyslipidemic and Non-Obese Dyslipidemic Patients (BMI-18.50 to 40.00 kg/m2) as per latest Updated WHO classification of BMI).
- •According to NCEP ATPIII Classification, the Pilot Project Study by Prevalence in local area and with the guidelines of CCRAS for Dyslipidemia; following were the levels to be selected for said Project.
- •Patient having Serum Total Cholesterol Level 200-239 mg/dl Patient having Serum LDL Cholesterol Level 130-159 mg/dl Patient having serum VLDL Cholesterol Level 40-60 mg/dl Patient having Serum HDL Cholesterol Level 20-40 mg/dl Patient having Serum Triglyceride Level 150-190 mg/dl Patients having one or more of above levels will be selected for said project.
Exclusion Criteria
- •Pregnant and lactating mothers.
- •Patients having Diabetes Mellitus.
- •Patients having history of Respiratory Disease Complications, Coronary Heart disease, Renal Disease Patients having Acute Complications like Severe Hypertension (B.P 150/90 mm Hg in those with age 60 years and older, and 140/90 mm Hg for adults less than 60 years.
- •according to Eighth Joint National Committee Guideline), Hepatitis or with history of major surgery etc.
- •Patients having disorders like Carcinoma anywhere in the body etc.
Outcomes
Primary Outcomes
Changes in Lipid Profile by Bruhatyadi Vati towards the Normal levels.
Time Frame: Outcome will be assessed at baseline, 4 weeks & 8 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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