MedPath

Effect of Medohara vati in Medoroga

Phase 1
Conditions
Health Condition 1: E785- Hyperlipidemia, unspecified
Registration Number
CTRI/2020/06/025899
Lead Sponsor
Patanjali Research Institute Haridwar
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Participant is not on a statin or other lipid-modifying therapy.

Plasma levels >=200 mg/dL for TC, >=130 mg/dL for LDL-C, <40 mg/dL for HDL-C, and >=150 mg/dL and (b) serum CRP >5 mg/dL.

Exclusion Criteria

oFemale participant of reproductive potential.

oParticipant is pregnant, breastfeeding, or expecting to conceive during the study.

oParticipant has history of cancer within 5 years of study (except certain types of skin and cervical cancer).

oParticipant is a user of recreational or illicit drugs or has a recent history of drug and/or alcohol abuse.

oParticipant has donated or received blood within 8 weeks of study start or intends to give/receive blood during the study.

oParticipant consumes more than 3 alcoholic drinks per day or more than 14 alcoholic drinks per week.

oParticipant is currently experiencing menopausal hot flashes.

oParticipant currently engages in vigorous exercise or an aggressive diet regimen.

oParticipant is at high risk for heart conditions.

oParticipant has Type 1 or Type 2 diabetes mellitus.

oParticipant has poorly controlled cardiac arrhythmias.

oParticipant has a history of stroke or other hemorrhage.

oParticipant has poorly controlled high blood pressure.

oParticipant has a thyroid condition or other endocrine/metabolic disease that would affect serum lipids.

oParticipant has a disease of the kidney or liver.

oParticipant has an ulcer within 3 months of screening.

oParticipant is Human Immunodeficiency Virus (HIV) positive.

oParticipant is taking cyclical hormonal contraceptives or non-continuous hormone replacement therapy.

oParticipant is taking or has taken an Organic Anion Transporter (OAT1/3) inhibitor/substrate within 3 days of screening.

oParticipant has taken an anti-obesity medication within 3 months of screening.

oParticipant is taking coumarin.

oParticipant is taking Non-Steroidal Anti-inflammatory Drugs (NSAIDs) (acetaminophen and Cyclooxygenase-2 (COX-2) inhibitors are allowed).

oParticipant is taking more than 100 mg aspirin per day.

oParticipant is being treated with oral, intravenous, or injected corticosteroids or anabolic agents.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Total Cholesterol <br/ ><br>S. Triglyceride <br/ ><br>S.HDL <br/ ><br>S.LDL <br/ ><br>S.VLDLTimepoint: every month, Before treatmetnt, After cmpletion of treatment
Secondary Outcome Measures
NameTimeMethod
BMITimepoint: every month for 2 months
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