Effects of a Nutraceutical Preparation on Cognitive Impairment in Hypertensive Patients

NCT ID: NCT02572219

Last Updated: 2017-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-11-30

Brief Summary

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Aim of this randomized, double-blind clinical study is to evaluate the efficacy of a nutraceutical preparation on early markers of cognitive impairment, in patients affected by arterial hypertension.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nutraceutical

Treated with nutraceutical compound

Group Type ACTIVE_COMPARATOR

Nutraceutical compound

Intervention Type DIETARY_SUPPLEMENT

Placebo

Treated with placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Nutraceutical compound

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Written informed consent;
* Males or females between 40 and 65 years of age;
* Hypertensive patients classified according to their SBP (Systolic Blood Pressure) and DBP (Diastolic Blood Pressure) values. Included patients will be those with stage 1 hypertension (SBP 140-159 mmHg; DBP 90-99 mmHg) and with stage 2 hypertension (SBP 160-179 mmHg; DBP 100-109 mmHg).

Exclusion Criteria

* Previous acute myocardial infarction (AMI);
* Previous stroke and/or transient ischemic attack (TIA);
* Diabetes mellitus;
* History of atrial fibrillation or other severe arrhythmias;
* Severe cardiovascular diseases;
* Renal pathologies (creatinine \> 1.4 mg/dL);
* Preexisting psychiatric pathologies;
* Neurodegenerative diseases, such as multiple sclerosis, lateral amyotrophic sclerosis, Parkinson, Alzheimer, neuromuscular pathologies, epilepsy;
* Diagnosis of dementia;
* Depression;
* Long-term regular use of anxiolytics drugs, antidepressant drugs, antipsychotic drugs, hypnoinducing drugs, cognitive stimulators.
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Neuromed IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Giuseppe Lembo

prof. Giuseppe Lembo

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IRCCS Neuromed

Pozzilli, (is), Italy

Site Status

Countries

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Italy

Other Identifiers

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LMB04

Identifier Type: -

Identifier Source: org_study_id

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