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

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.

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
CTRI
Registry ID
CTRI/2012/12/003213
Enrollment
40
Registered
2012-12-13
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Hyperlipidemia

Interventions

Intervention1: Narsimha a polyherbal forulation: Narsimha is an ayurvedic polyherbal formulation containing Comiphora mukul, Tinospora cordifolia, Curcuma longa, Trigonella foenum-graceum & piper nigr

Sponsors

Nisarga Biotech Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
To assess the efficacy of poly-herbal formulation â??Narsimhaâ?? in hyperlipidemic subjectsTimepoint: 90 and 120 days

Secondary

MeasureTime frame
To confirm the safety of poly-herbal formulation â??Narsimhaâ?? in hyperlipidemic subjects.Timepoint: 90 and 120 days

Countries

India

Contacts

Public ContactDrAbhijeet Deshpande

Deenanath Mangeshkar Hospital & Research Centre, Pune

padmaatul@gmail.com02040151000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026