clinical study to assess the effectiveness and safety of ayurvedic herbomineral drug shivagutika in management of high cholesterol.

Phase 3

• Conditions: Health Condition 1: E038- Other specified hypothyroidism

• Registration Number: CTRI/2017/05/008545
• Lead Sponsor: Rajiv Gandhi University of Health Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1.Patients fulfilling the diagnostic criteria.

2.Lipid profile, showing any one or more of the following criteria.

Serum cholesterol >200 mg/dl

Serum Triglycerides >150 mg/dl

Serum LDL >130 mg/dl

Serum VLDL >40 mg/dl

Serum HDL <40 for male <30 for female

Ratio of HDL to Cholesterol >4.5

Apolipoprotien B >125mg/dl

3.Both fresh and treated cases will be included (Flush out period of 7 days is maintained for treated cases)

Exclusion Criteria

1.Patients having history of serious cardiac disorders like myocardial infarction, cardiac failure, etc.

2.Patients having any major illness, insulin dependent diabetes mellitus, Type II diabetes mellitus that is poorly controlled

3.Patients having a history of untreated thyroid disorder

4.Hyperlipidemia due to drugs (e.g., glucocorticoids)

5.Pregnant females and lactating mothers

6.Renal insufficiency

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the effect of shivagutika in dyslipidemia (lipid profile and on Apo lipoprotein B). <br/ ><br>To evaluate the effect of Navaka guggulu in dyslipidemia (lipid profile and on Apo lipoprotein B). <br/ ><br>To evaluate the safety of shiva gutika and Navaka guggulu. <br/ ><br>To compare the efficacy of shiva gutika with control drug Navaka guggulu. <br/ ><br>Timepoint: Lipid profile,Apolipoprotien B,Liver function tests will be performed before intervention and after 45 days of intervention.

Secondary Outcome Measures

Name	Time	Method
Safe and cost effective natural drug for managing dyslipidemia, prevention of coronary artery diseases.Timepoint: 0 day and 45th day