Cholesterol Lowering Effect of Cardio-Complement, an Ayurveda Formulation

July 16, 2021 updated by: NMP Medical Research Institute

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Rajasthan
      • Jaipur, Rajasthan, India
        • Gyansanjeevani

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NMP Medical Research Institute

Collaborators

Aarogyam UK

Investigators

  • Principal Investigator: Prashanna T Chockalingam, NMP Medical Research Institute, India
  • Study Chair: Abhijit Venu, Aarogyam UK
  • Study Director: Skanthesh Lakshmanan, NMP Medical Research Institute, India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2021

Primary Completion (ACTUAL)

June 30, 2021

Study Completion (ACTUAL)

July 5, 2021

Study Registration Dates

First Submitted

July 16, 2021

First Submitted That Met QC Criteria

July 16, 2021

First Posted (ACTUAL)

July 23, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 23, 2021

Last Update Submitted That Met QC Criteria

July 16, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMP/Aaro/21-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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