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Clinical Trials/CTRI/2010/091/000368
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

Sponsor
Nisarga Biotech Pvt Ltd
Sponsor Class
Pharmaceutical industry-Indian

Study Sites (1)

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