Health Condition 1: null- Hyperlipidemia in men & women
Conditions
Interventions
Intervention1: NARSIMHA: 450mg bid for 3 months
Control Intervention1: ATORVASTATIN: Atorlip tab 10mg od for 3 months
Sponsors
Nisarga Biotech Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1) 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. 3) The subject willing to give written informed consent and willing to comply with study protocol. 4) The subject not received lipid lowering drugs at least 3 months prior to recruitment.
Exclusion criteria
Exclusion criteria: 1) The subject with cardiovascular disease, diabetes mellitus, chronic inflammatory diseases, untreated hypertension ( > 140/95 mm Hg) or liver/renal disease. 2) Subject participating in other clinical trial or planned participation in another clnical trial during the present trial period. 3) The Subject with H/o smoking or the subject receiving anti-inflammatory or lipid-lowering medication. 4) The subject with diseases demanding continuous administration of B-blockers, calcium antagonists, hypoglycemic agents or diuretics. 5) History of a previous severe allergic reaction (generalized urticaria; angioedema or anaphylaxix), chronic alcohol consumption and/or intravenous drug abuse. 6) Pregnant and lactating women. 7) History of contraceptive, harmone replacement therapy (HRT) or steroids since last 3 months. 8) Subjects with history of tuberculosis, HIV or malignancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EfficacyTimepoint: Measured on Day 1, 45, 90 & 120. | — |
Secondary
| Measure | Time frame |
|---|---|
| SafetyTimepoint: Measured on Day 1, 45, 90 & 120. | — |
Countries
India
Contacts
Public ContactDr Nitin Patki
Outcome results
None listed