A clinical study of KaraHeart for the management of cholesterol level in human participants.

Phase 2/3

Completed

• Conditions: Preventative Interventions

• Registration Number: CTRI/2020/07/026907
• Lead Sponsor: GreenChem

Brief Summary

This proposed study is a randomized, double-blind, placebo-controlled trial, investigating the efficacy and safety of KaraHeart versus placebo in improving the symptoms of hypercholesterolemia in otherwise healthy population aged between 20 to 60 years. The observed outcomes through primary and secondary endpoints results will be analysed to check the safety and efficacy of this synergistic herbal formulation.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-30
• Last Update Posted: 2021-07-12

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 1.Adult men and women subjects between the age groups of 20–60 years with the confirmed case of mild to moderate hyperlipidemia.
• 2.As per ATP III guidelines; baseline LDL ranging >100 mg/dL, TC >200 mg/dL, TGL ranging 150-199 mg/dL, VLDL-Cholesterol >40 mg/dL, HDL-cholesterol: Men- <40mg/dL, and women -<50mg/dL 3.Subjects having all or at least any one of the diagnostic criteria mentioned above will be selected for the study.
• 4.Subjects with low BMI but abnormal lipid profile.
• 5.Subjects who are able to understand the risks/benefits of the protocol and are willing to give written informed consent.

Exclusion Criteria

• 1.Subjects on concurrent lipid-lowering medications like statins, or fibrates, or dietary supplements within 30 days prior to screening.
• 2.Subjects suffering from Hyperlipidemia due to Consumption of drugs such as glucocorticoids.
• 3.Subjects with chronic diseases requiring continuous use of vasoactive,diuretics or lipid-lowering drugs.
• 5.Subjects having history of any major illness of cardiovascular diseases eg.Angina pectoris, myocardial infarction etc.
• 6.Subjects having a history of thyroid disorder (TSH- levels of <0.4 or >10µg/dL), renal disorder, cholelithiasis or polycystic ovary syndrome (PCOS).
• 7.Subjects having history of diabetes (Type I or Type II) except other than the subject having the pre-diabetes condition with the fasting blood glucose between 100 to 125 mg/dl or random blood glucose 140-199 mg/dl.
• 8.Subjects having abnormal liver or kidney function test (ALT or AST) 2 times the upper limit of normal; elevated creatinine (male 125 μmol/L, female 110 μmol/L).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from the baseline to the end of the treatment period in the levels of total cholesterol,High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Very Low Density Lipoprotein (VLDL)and Triglyceride (TGL)	Day 0, Day 30, Day 60, Day 90, Day 120

Secondary Outcome Measures

Name	Time	Method
Change from the baseline to the end of the treatment period in the level of Serum Apolipoprotein B	Day 0 and Day 120
Change from the baseline to the end of the treatment period in the level of Lipid peroxidation	Day 0 and Day 120
Change from the baseline to the end of the treatment period in the level of C-Reactive Protein	Day 0 and Day120
Change from the baseline to the end of the treatment period in the level of Total Cholesterol Vs HDL Cholesterol	Day 0, Day 30, Day 60, Day 90, Day 120
Change from the baseline to the end of the treatment period in the level of Serum Apolipoprotein A1	Day 0 and Day 120
Change from the baseline to the end of the treatment period in the level of HbA1C	Day 0 and Day 120
Change from the baseline to the end of the treatment period in the level of Ankle Brachial reflex	Day 0 and Day 120

Trial Locations

Locations (1)

Shettys Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Shettys Hospital

🇮🇳Bangalore, KARNATAKA, India

DrSucharitha L

Principal investigator

08025732886

sucharitha.pandit@gmail.com