Role of a Combination of Nutraceuticals (Ritmonutra) on Benign Supraventricular and Ventricular Arrhythmias
Study on the Role of a Combination of Nutraceuticals (Ritmonutra) With an Effect on Benign Supraventricular and Ventricular Arrhythmias in Subjects Free of a Specific Organic Heart Disease.
1 other identifier
interventional
1,500
1 country
1
Brief Summary
Study on the role of a combination of nutraceuticals (Ritmonutra) with an effect on benign supraventricular and ventricular extrasystoles in subjects free of a specific organic heart disease. It has been suggested treatment with a nutritional supplement, able to normalize the 'cardiac electrophysiology' and help to maintain wellness. Ritmonutra ® is a combination of nutraceuticals®, including Omega-3 polyunsaturated fatty acids, Hawthorn, Astaxanthin and Vitamin E, help to normalize the heart pacing, reducing the total number of benign extrasystoles and consequently improving the quality of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2012
CompletedFirst Posted
Study publicly available on registry
July 24, 2012
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFebruary 3, 2016
February 1, 2016
1.2 years
July 12, 2012
February 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction of the ventricular and atrial arrhythmias.
4 week
Secondary Outcomes (1)
Improvement in life quality
4 week
Study Arms (2)
Placebo
PLACEBO COMPARATORInert Placebo - Vitamin B complex + diet
Ritmonutra
ACTIVE COMPARATOROmega-3 polyunsaturated fatty acids, Hawthorn, Astaxanthin, Vitamin E, Vitamin B complex + diet
Interventions
Ritmonutra ® contains: 720 mg of Fish Oil with Omega-3, including 480 mg of EPA and 40 mg of DHA, Hawthorn (extract from Crataegus mongyna) 300 mg equivalent to 5.4 mg of vitexin, 4 mg of Astaxanthin and 36 mg of Vitamin E
Eligibility Criteria
You may qualify if:
- Diagnosis of ventricular or atrial extrasystoles
You may not qualify if:
- Presence of organic cardiomyopathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ambulatorio Ipertensione e Unità Coronarica Federico II University
Naples, 80131, Italy
Related Publications (1)
Izzo R, de Simone G, Giudice R, Chinali M, Trimarco V, De Luca N, Trimarco B. Effects of nutraceuticals on prevalence of metabolic syndrome and on calculated Framingham Risk Score in individuals with dyslipidemia. J Hypertens. 2010 Jul;28(7):1482-7. doi: 10.1097/HJH.0b013e3283395208.
PMID: 20498621RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bruno Trimarco, MD
Federico II University, Dipartimento di medicina Clinica Scienze Cardiovascolari ed Immunologiche
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Full Professor of Cardiology
Study Record Dates
First Submitted
July 12, 2012
First Posted
July 24, 2012
Study Start
December 1, 2012
Primary Completion
February 1, 2014
Study Completion
December 1, 2014
Last Updated
February 3, 2016
Record last verified: 2016-02