Skip to main content
OpenTrials
Completed

NCT Number: NCT04974853

Cholesterol Lowering Effect of Cardio-Complement, an Ayurveda Formulation

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)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypercholesterolemia Cardiovascular Diseases Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gyansanjeevani

Jaipur, Rajasthan, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardio-complement

Combination Product

Ayurvedic combination of Terminalia Arjuna, Withania Sominifera, Garcinia Cambogia and piperine (as bioenhancer) in pre-specified dosage.

Primary outcomes

  1. Reduction of LDL-cholesterol

    Time frame: Change from baseline to 2 weeks

Secondary outcomes

  1. Reduction of total cholesterol

    Time frame: Changes from baseline to 2 weeks

  2. Increase of HDL cholesterol

    Time frame: Change from baseline to 2 weeks

  3. Reduction of Triglycerides

    Time frame: Change from baseline to 2 weeks

Sponsors and collaborators

Lead sponsor

NMP Medical Research Institute

Other

Collaborators

  • Aarogyam UK

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 23, 2021
Registry last updated
Jul 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.