CTRI/2017/05/008545
Recruiting
Phase 3
Single blind randomized controlled clinical study to evaluate the efficacy and safety of shivagutika in dyslipidemia
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: E038- Other specified hypothyroidism
- Sponsor
- Rajiv Gandhi University of Health Sciences
- Enrollment
- 60
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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