Effect of the Dietary Supplement Taxifolin Aqua on the Recovery Period After COVID-19 Pneumonia

NCT ID: NCT04871802

Last Updated: 2021-05-04

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-10

Study Completion Date

2021-10-01

Brief Summary

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Objective of the study is to evaluate the effect of Taxifolin Aqua therapy on the indicators of respiratory function, the state of the arterial wall, the contractile function of the myocardium, as well as to assess the effect of Taxifolin Aqua therapy on markers of biological age, quality of patients life.

Detailed Description

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The study will include 100 patients who had covid pneumonia 3 months ago. If the inclusion / exclusion criteria are met, the patient is asked to sign an informed consent to participate in the study. Consenting patients are randomized to an intervention group or a control group. The control group (n = 50) will receive standard therapy, patients from the intervention group (n = 50) will be prescribed Taxifolin Aqua 30 mg per day in addition to standard therapy. Patients will be randomized to the control and main group using random number spreadsheets, assuming that the control and main groups will be homogeneous in the main demographic and clinical parameters. Patient monitoring will be carried out within 2 months from the date of inclusion. A follow-up visit is scheduled in 2 months. During the study, the patient will be regularly monitored for tolerance and safety of therapy with Taxifolin Aqua.

Conditions

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Covid19

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Taxifolin Aqua group

Taxifolin Aqua 30 mg per day in addition to standard therapy

Group Type EXPERIMENTAL

Taxifolin Aqua

Intervention Type DIETARY_SUPPLEMENT

Dietary supplement

Control group

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Taxifolin Aqua

Dietary supplement

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

Patients of both sexes who had covid pneumonia 3 months ago and signed an informed consent and aged 18+.

Exclusion Criteria

Standard contraindications to Taxifolin Aqua use.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pirogov Russian National Research Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Irina Strazhesko, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Reserach Center for Gerontology

Locations

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Russian Clinical Research Center for Gerontology

Moscow, , Russia

Site Status

Countries

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Russia

Central Contacts

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Irina Strazhesko, MD, PhD

Role: CONTACT

Olga Tkacheva, MD, PhD

Role: CONTACT

+74991871254

Other Identifiers

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COVID-AQUA-1

Identifier Type: -

Identifier Source: org_study_id

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