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Evaluation Through Innovative Examinations of Intestinal Dysbiosis Status in Patients Diagnosed With Cardiovascular Diseases and Evaluation of the Efficacy of Natural and Probiotic Extracts in the Non-pharmacological Approach to Improving Intestinal Dysbiosis Status.

ConditionAcute Coronary Syndromes (ACS)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-70
SponsorCasa di Cura Dott. Pederzoli

About this trial

The prospective experimental study aims to take an instantaneous photograph of the subject at time T0 and after 24 hours of intestinal permeability and dysbiosis indices in patients with acute coronary syndromes (ACS) which include unstable coronary artery disease (unstable angina) and acute myocardial infarction (AMI). The aim is to verify whether essential oils in particular formulations with high bioavailability are able to re-establish intestinal eubiosis after 2 months, confirmed by tests laboratory specifics such as metabolomics.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Signing of informed consent

2. Diagnosis of Acute Coronary Syndrome (ACS)

3. Age 30-70

Disqualifiers

Diagnosis of conditions such as HIV, cancer and diabetes I and II Furthermore, if a female patient becomes pregnant during the trial, this will be one of the reasons for early exit from the study.

Trial design

Design model

Single group

Treatments tested in this trial

  • Tea tree (Melaleuca alternifolia), Cinnamon (Cynnamomum zeylanicum) bark, Clove carnation (Eugenia caryopyllus) flowers, Red thyme (Thymus vulgaris) plant

    Dietary supplement

    Patients will take 2 capsules/day of the product

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: non-pharmacological therapy armOther 1 intervention

Trial outcomes

Primary outcomes

1

characterization of urinary metabolites

to assess the presence of dysmetabolisms

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

state of metabolic cardio risk

picture of all the pro-atherogenic factors

Time frame
through study completion, an average of 1 year
2

urinary dysmetabolism

interaction of non-pharmacological therapy and urinary dysmetabolisms

Time frame
through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Casa di Cura Dott. Pederzoli

Lead sponsor

Herboplanet Srl

Collaborator

Source ClinicalTrials.gov
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