A Phase II, Open Label Proof of Concept Study of Safety and Lipid-lowering Effects of Poly-herbal formulation Narsimhain in Hyperlipidemic Men & Women, visiting Ayurvedic O.P.D.

isarga Biotech Pvt Ltd0 个研究点目标入组 40 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1)The subject of 30-70 years of age of either sex with established hyperlipidema
•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 with following primary selection criteria:
•LDL-C concentration > 130 mg %;
•Triglyceride level > 150 mg/dl
•5)The subject not receiving lipid lowering drugs at least 3 months prior to the recruitment.

•1)Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, thyroid dysfunction as determined by medical history, physical examination or laboratory test, which in the opinion of the investigator, might interfere with the study objectives.
•2)Subject participating in other clinical trial or planned participation in another clinical trial during the present trial period.
•3)The subject receiving anti-inflammatory or lipid-lowering medication such as statins or finofibrates.
•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 utricaria; angioedema or anaphylaxix).
•6)History of chronic alcohol consumption and/or intravenous drug abuse.
•7)Pregnant and lactating women.
•8)History of contraceptive, hormone replacement therapy (HRT) or steroids since last 3 months.
•9)Subjects with history of tuberculosis, HIV or malignancy.
•10)Hypersensitivity to any component of the drug

发起方

isarga Biotech Pvt Ltd