Back to resultsCholesterol Lowering Effect of Cardio-Complement, an Ayurveda Formulation
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Cardio-complement
Sponsored by
About this trial
This is an interventional supportive care trial for Hypercholesterolemia focused on measuring Ayurveda, Cholesterol, Cardiovascular Diseases, Hyperlipidemia
Eligibility Criteria
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
Sites / Locations
- Gyansanjeevani
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ayurveda Formulation
Arm Description
Patients with hypercholesterolemia treated with Ayurveda formulation, Cardio-Complement
Outcomes
Primary Outcome Measures
Reduction of LDL-cholesterol
Secondary Outcome Measures
Reduction of total cholesterol
Increase of HDL cholesterol
Reduction of Triglycerides
Full Information
NCT ID
NCT04974853
First Posted
July 16, 2021
Last Updated
July 16, 2021
Sponsor
NMP Medical Research Institute
Collaborators
Aarogyam UK
1. Study Identification
Unique Protocol Identification Number
NCT04974853
Brief Title
Cholesterol Lowering Effect of Cardio-Complement, an Ayurveda Formulation
Official Title
Cholesterol Lowering Effect of Cardio-Complement, an Ayurveda Formulation: Feasibility Study on Patients With Mild-to-moderate Hypercholesterolemia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
July 5, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NMP Medical Research Institute
Collaborators
Aarogyam UK
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
Ayurveda, Cholesterol, Cardiovascular Diseases, Hyperlipidemia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ayurveda Formulation
Arm Type
Experimental
Arm Description
Patients with hypercholesterolemia treated with Ayurveda formulation, Cardio-Complement
Intervention Type
Combination Product
Intervention Name(s)
Cardio-complement
Intervention Description
Ayurvedic combination of Terminalia Arjuna, Withania Sominifera, Garcinia Cambogia and piperine (as bioenhancer) in pre-specified dosage.
Primary Outcome Measure Information:
Title
Reduction of LDL-cholesterol
Time Frame
Change from baseline to 2 weeks
Secondary Outcome Measure Information:
Title
Reduction of total cholesterol
Time Frame
Changes from baseline to 2 weeks
Title
Increase of HDL cholesterol
Time Frame
Change from baseline to 2 weeks
Title
Reduction of Triglycerides
Time Frame
Change from baseline to 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prashanna T Chockalingam
Organizational Affiliation
NMP Medical Research Institute, India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Abhijit Venu
Organizational Affiliation
Aarogyam UK
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Skanthesh Lakshmanan
Organizational Affiliation
NMP Medical Research Institute, India
Official's Role
Study Director
Facility Information:
Facility Name
Gyansanjeevani
City
Jaipur
State/Province
Rajasthan
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Cholesterol Lowering Effect of Cardio-Complement, an Ayurveda Formulation
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