CTRI/2010/091/000368Not yet recruitingPhase 3
A phase III, double blind, randomised, parallel design, controlled clinical study to assess and compare the lipid-lowering effects and safety of poly-herbal formulation "NARSIMHA" with Atorvastatin in hyperlipidemic men and women.
Nisarga Biotech Pvt Ltd1 site in 1 country80 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Efficacy
Study Overview
Brief Summary
A phase III, double blind, randomized, parallel design, controlled clinical study to evaluate the efficacy and safety of poly-herbal formulation "NARSIMHA" is undertaken in 80 hyperlipidemic patients of 30 to 70 years of age. The trial shall be conducted at: Deenanath Mangeshkar Hospital & Research Centre, Pune. Treatment will be given for 3 months. Atorvastatin shall be used as a comparator (active controlled) drug. Efficacy of the drug will be evaluated based on visits on day (-7), 45, 90 & 120.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 30.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •The subject of 30-70 years of age of either sex with established hyperlipidemia 2)Free of obvious health problems as established by medical history and physical examination.
- •The subject willing to give written informed consent and willing to comply with study protocol.
- •The subject not received lipid lowering drugs at least 3 months prior to recruitment.
Exclusion Criteria
- •The subject with cardiovascular disease, diabetes mellitus, chronic inflammatory diseases, untreated hypertension (> 140/95 mm Hg) or liver/renal disease.
- •Subject participating in other clinical trial or planned participation in another clnical trial during the present trial period.
- •The Subject with H/o smoking or the subject receiving anti-inflammatory or lipid-lowering medication.
- •History of a previous severe allergic reaction (generalized urticaria; angioedema or anaphylaxix), chronic alcohol consumption and/or intravenous drug abuse.
- •Pregnant and lactating women.
- •History of contraceptive, harmone replacement therapy (HRT) or steroids since last 3 months.
- •Subjects with history of tuberculosis, HIV or malignancy.
Outcomes
Primary Outcomes
Efficacy
Time Frame: Measured on Day 1, 45, 90 & 120.
Secondary Outcomes
- Safety(Measured on Day 1, 45, 90 & 120.)
Investigators
Study Sites (1)
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