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

Primary Purpose

Covid19

Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Taxifolin Aqua
Sponsored by
Pirogov Russian National Research Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Russian Clinical Research Center for Gerontology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Taxifolin Aqua group

Control group

Arm Description

Taxifolin Aqua 30 mg per day in addition to standard therapy

No intervention

Outcomes

Primary Outcome Measures

Dynamics of spirometry indices
spirometry
Dynamics of ECHO CG
ECHO CG
Dynamics of pulse wave velocity
applanation tonometry
Dynamics of augmentation index
applanation tonometry

Secondary Outcome Measures

Dynamics of biological age
Laboratory indicators

Full Information

First Posted
March 21, 2021
Last Updated
May 1, 2021
Sponsor
Pirogov Russian National Research Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04871802
Brief Title
Effect of the Dietary Supplement Taxifolin Aqua on the Recovery Period After COVID-19 Pneumonia
Official Title
A Prospective, Randomized, Comparative Study in Two Groups to Assess the Effect of the Use of a Dietary Supplement Taxifolin Aqua on the Recovery Period After COVID Pneumonia and on the Biological Age
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 10, 2021 (Anticipated)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
October 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pirogov Russian National Research Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Taxifolin Aqua group
Arm Type
Experimental
Arm Description
Taxifolin Aqua 30 mg per day in addition to standard therapy
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Taxifolin Aqua
Intervention Description
Dietary supplement
Primary Outcome Measure Information:
Title
Dynamics of spirometry indices
Description
spirometry
Time Frame
In 2 months after recruitment
Title
Dynamics of ECHO CG
Description
ECHO CG
Time Frame
In 2 months after recruitment
Title
Dynamics of pulse wave velocity
Description
applanation tonometry
Time Frame
In 2 months after recruitment
Title
Dynamics of augmentation index
Description
applanation tonometry
Time Frame
In 2 months after recruitment
Secondary Outcome Measure Information:
Title
Dynamics of biological age
Description
Laboratory indicators
Time Frame
In 2 months after recruitment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Irina Strazhesko, MD, PhD
Email
Istrazhesko@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Olga Tkacheva, MD, PhD
Phone
+74991871254
Email
rgnkc@rgnkc.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irina Strazhesko, MD, PhD
Organizational Affiliation
Clinical Reserach Center for Gerontology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Russian Clinical Research Center for Gerontology
City
Moscow
ZIP/Postal Code
129226
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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