Cholesterol Lowering Effect of Cardio-Complement, an Ayurveda Formulation

Study Overview
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Brief Summary
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The aim of this feasibility study was to assess the lipid-lowering effects and safety of a Ayurveda formulation containing Terminalia Arjuna, Withania Sominifera, Garcinia Cambogia and piperine (as bioenhancer)

Detailed Description
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The COVID-19 related lockdowns severely affected the healthcare in India, specially in second wave of COVID-19. This research presents the applicability of Ayurveda formulation to analyze the impact on lipid profile during the lockdown. Patients with hyperlipidemia who referred to Gyansanjeevani were recruited. All participants were enrolled in the study after a complete physical examination and medical history remotely over the virtual secure platform.

Official Title
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Cholesterol Lowering Effect of Cardio-Complement, an Ayurveda Formulation: Feasibility Study on Patients With Mild-to-moderate Hypercholesterolemia

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Combination Product: Cardio-complement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 65 years BMI between 18.5 and 40 kg/m2 Total Cholesterol >180 mg/dl No clinically significant medical history Willing to participate to the study by complying with the protocol Able to provide written informed consent Exclusion Criteria: Metabolic disorder such as diabetes, uncontrolled thyroidal trouble or other metabolic disorder, Severe chronic disease History of ischemic cardiovascular event, Uncontrolled hypertension Under treatment or dietary supplement which could affect study parameter

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ayurveda Formulation<br>Patients with hypercholesterolemia treated with Ayurveda formulation, Cardio-Complement | Combination Product: Cardio-complement<br>* Ayurvedic combination of Terminalia Arjuna, Withania Sominifera, Garcinia Cambogia and piperine (as bioenhancer) in pre-specified dosage.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of LDL-cholesterol |  | Change from baseline to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of total cholesterol |  | Changes from baseline to 2 weeks | 
| Increase of HDL cholesterol |  | Change from baseline to 2 weeks | 
| Reduction of Triglycerides |  | Change from baseline to 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ayurveda, Cholesterol, Cardiovascular Diseases, Hyperlipidemia