Cholesterol Lowering Effect of Cardio-Complement, an Ayurveda Formulation

Not Applicable

Completed

• Conditions: Hypercholesterolemia
• Interventions: Combination Product: Cardio-complement

• Registration Number: NCT04974853
• Lead Sponsor: NMP Medical Research Institute

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.

Study Timeline

• Status Verified: 2021-06
• Study Start: 2021-06-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-07-05
• Study First Submitted: 2021-07-16
• Study First Submitted QC: 2021-07-16
• Last Update Submitted: 2021-07-16
• Study First Posted: 2021-07-23
• Last Update Posted: 2021-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ayurveda Formulation	Cardio-complement	Patients with hypercholesterolemia treated with Ayurveda formulation, Cardio-Complement

Primary Outcome Measures

Name	Time	Method
Reduction of LDL-cholesterol	Change from baseline to 2 weeks

Secondary Outcome Measures

Name	Time	Method
Reduction of total cholesterol	Changes from baseline to 2 weeks
Reduction of Triglycerides	Change from baseline to 2 weeks
Increase of HDL cholesterol	Change from baseline to 2 weeks

Trial Locations

Locations (1)

Gyansanjeevani; 🇮🇳 Jaipur, Rajasthan, India