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A clinical trial to study the safety & lipid lowering effects of poly-herbal formulation Narsimha in men & wome

Phase 2
Conditions
Health Condition 1: null- Hyperlipidemia
Registration Number
CTRI/2012/12/003213
Lead Sponsor
isarga Biotech Pvt Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
40
Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

Study Type
PMS
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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