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NCT04974853 Clinical Trial

Cholesterol Lowering Effect of Cardio-Complement, an Ayurveda Formulation

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04974853
Other study ID # NMP/Aaro/21-11
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date July 5, 2021

Study information
Verified date June 2021
Source NMP Medical Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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)

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date July 5, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Combination Product:
• Cardio-complement
Ayurvedic combination of Terminalia Arjuna, Withania Sominifera, Garcinia Cambogia and piperine (as bioenhancer) in pre-specified dosage.

Locations
Country Name City State
India Gyansanjeevani Jaipur Rajasthan

Sponsors (2)
Lead Sponsor Collaborator
NMP Medical Research Institute Aarogyam UK

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reduction of LDL-cholesterol Change from baseline to 2 weeks
Secondary Reduction of total cholesterol Changes from baseline to 2 weeks
Secondary Increase of HDL cholesterol Change from baseline to 2 weeks
Secondary Reduction of Triglycerides Change from baseline to 2 weeks
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