HypercholesterolemiaNCT04974853
Cholesterol Lowering Effect of Cardio-Complement, an Ayurveda Formulation
A study testing Cardio-complement in people with Hypercholesterolemia, run by NMP Medical Research Institute at 1 site in India.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Cardio-complement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jun 2021to 5 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
Read the 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.
- Conditions
- Hypercholesterolemia
- Being tested
- Cardio-complement
- Keywords
- Ayurveda, Cholesterol, Cardiovascular Diseases, Hyperlipidemia
- Medical subject headings
- Hypercholesterolemia, Cardiovascular Diseases, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardio-complementCombination product
Ayurvedic combination of Terminalia Arjuna, Withania Sominifera, Garcinia Cambogia and piperine (as bioenhancer) in pre-specified dosage.
| Study group | Role | What they receive |
|---|---|---|
| Ayurveda Formulation | Experimental | Patients with hypercholesterolemia treated with Ayurveda formulation, Cardio-Complement Receives: Combination Product: Cardio-complement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of LDL-cholesterol
Measured: Change from baseline to 2 weeks
Secondary outcomes (3)
Reduction of total cholesterol
Measured: Changes from baseline to 2 weeks
Increase of HDL cholesterol
Measured: Change from baseline to 2 weeks
Reduction of Triglycerides
Measured: Change from baseline to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start1 Jun 2021
- Primary completion30 Jun 2021
- Study completion5 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- NMP Medical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Aarogyam UK
- Responsible party
- Sponsor
- Investigators
- Prashanna T Chockalingam, Principal investigator, NMP Medical Research Institute, IndiaAbhijit Venu, Study chair, Aarogyam UKSkanthesh Lakshmanan, Study director, NMP Medical Research Institute, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974853
- Sponsor's protocol ID
- NMP/Aaro/21-11
- Status last verified
- Jun 2021
- First submitted
- 16 Jul 2021
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cholesterol Lowering Effect of Cardio-Complement, an Ayurveda Formulation: Feasibility Study on Patients With Mild-to-moderate Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT04974853
- Acronym / sponsor ID
- NMP/Aaro/21-11
- Conditions
- Hypercholesterolemia
- Keywords
- Ayurveda, Cholesterol, Cardiovascular Diseases, Hyperlipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- NMP Medical Research InstituteUniversity, hospital or other
- Collaborators
- Aarogyam UK
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 5 Jul 2021 (actual)
- First posted
- 23 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ayurveda Formulation | Experimental | Combination Product: Cardio-complementPatients with hypercholesterolemia treated with Ayurveda formulation, Cardio-Complement |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardio-complementAyurvedic combination of Terminalia Arjuna, Withania Sominifera, Garcinia Cambogia and piperine (as bioenhancer) in pre-specified dosage. | Combination product | Ayurveda Formulation |
Primary outcome
Reduction of LDL-cholesterol
Time frame: Change from baseline to 2 weeks
3 secondary outcomes
Reduction of total cholesterol
Time frame: Changes from baseline to 2 weeks
Increase of HDL cholesterol
Time frame: Change from baseline to 2 weeks
Reduction of Triglycerides
Time frame: Change from baseline to 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Hypercholesterolemia
Active, not recruitingObservational study
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Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
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RecruitingObservational study
A Study to Evaluate the Effectiveness and Safety of Fixed-Dose Combination of Pitavastatin/ Ezetimibe
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prashanna T Chockalingam principal investigator
NMP Medical Research Institute, India
Abhijit Venu study chair
Aarogyam UK
Skanthesh Lakshmanan study director
NMP Medical Research Institute, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardio-complement in people with Hypercholesterolemia, run by NMP Medical Research Institute at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of LDL-cholesterol (time frame: Change from baseline to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.