Cholesterol Lowering Effect of Cardio-Complement, an Ayurveda Formulation

NCT ID: NCT04974853

Last Updated: 2021-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2021-07-05

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.

Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Ayurveda Formulation

Patients with hypercholesterolemia treated with Ayurveda formulation, Cardio-Complement

Group Type EXPERIMENTAL

Cardio-complement

Intervention Type COMBINATION_PRODUCT

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

Interventions

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Cardio-complement

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

Intervention Type COMBINATION_PRODUCT

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aarogyam UK

OTHER

Sponsor Role collaborator

NMP Medical Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prashanna T Chockalingam

Role: PRINCIPAL_INVESTIGATOR

NMP Medical Research Institute, India

Abhijit Venu

Role: STUDY_CHAIR

Aarogyam UK

Skanthesh Lakshmanan

Role: STUDY_DIRECTOR

NMP Medical Research Institute, India

Locations

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Gyansanjeevani

Jaipur, Rajasthan, India

Site Status

Countries

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India

Other Identifiers

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NMP/Aaro/21-11

Identifier Type: -

Identifier Source: org_study_id

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