A clinical trial to assess the efficacy and safety of poly-herbal formuation "NARSIMHA" in comparison with Atorvastatin in hyperlipimedic men and women.

Phase 3

Not yet recruiting

• Conditions: Hyperlipidemia in men & women

• Registration Number: CTRI/2010/091/000368
• Lead Sponsor: Nisarga Biotech Pvt Ltd

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2013-10-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 80

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

• 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.
• 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.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy	Measured on Day 1, 45, 90 & 120.

Secondary Outcome Measures

Name	Time	Method
Safety	Measured on Day 1, 45, 90 & 120.

Trial Locations

Locations (1)

Deenanath Mangeshkar Hospital & Research Centre; 🇮🇳 Pune, MAHARASHTRA, India

Deenanath Mangeshkar Hospital & Research Centre

🇮🇳Pune, MAHARASHTRA, India

Dr Nitin Patki

Principal investigator

02040151000

nitin1patki@gmail.com.org