NCT04974853

Brief 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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2021

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 23, 2021

Completed
Last Updated

July 23, 2021

Status Verified

June 1, 2021

Enrollment Period

29 days

First QC Date

July 16, 2021

Last Update Submit

July 16, 2021

Conditions

Hypercholesterolemia

Keywords

AyurvedaCholesterolCardiovascular DiseasesHyperlipidemia

Outcome Measures

Primary Outcomes (1)

  • Reduction of LDL-cholesterol

    Change from baseline to 2 weeks

Secondary Outcomes (3)

  • 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

Study Arms (1)

Ayurveda Formulation

EXPERIMENTAL

Patients with hypercholesterolemia treated with Ayurveda formulation, Cardio-Complement

Combination Product: Cardio-complement

Interventions

Cardio-complementCOMBINATION_PRODUCT

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

Ayurveda Formulation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gyansanjeevani

Jaipur, Rajasthan, India

Location

MeSH Terms

Conditions

HypercholesterolemiaCardiovascular DiseasesHyperlipidemias

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Prashanna T Chockalingam

    NMP Medical Research Institute, India

    PRINCIPAL INVESTIGATOR

  • Abhijit Venu

    Aarogyam UK

    STUDY CHAIR

  • Skanthesh Lakshmanan

    NMP Medical Research Institute, India

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2021

First Posted

July 23, 2021

Study Start

June 1, 2021

Primary Completion

June 30, 2021

Study Completion

July 5, 2021

Last Updated

July 23, 2021

Record last verified: 2021-06

Locations

IN(1)