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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04871802
Recruitment Status : Unknown
Verified March 2021 by Pirogov Russian National Research Medical University.
Recruitment status was:  Not yet recruiting
First Posted : May 4, 2021
Last Update Posted : May 4, 2021
Sponsor:
Information provided by (Responsible Party):
Pirogov Russian National Research Medical University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Covid19 Dietary Supplement: Taxifolin Aqua Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Estimated Study Start Date : May 10, 2021
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Taxifolin Aqua group
Taxifolin Aqua 30 mg per day in addition to standard therapy
 Dietary Supplement: Taxifolin Aqua
Dietary supplement
No Intervention: Control group
No intervention


Outcome Measures
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Primary Outcome Measures :
  1. Dynamics of spirometry indices [ Time Frame: In 2 months after recruitment ]
    spirometry

  2. Dynamics of ECHO CG [ Time Frame: In 2 months after recruitment ]
    ECHO CG

  3. Dynamics of pulse wave velocity [ Time Frame: In 2 months after recruitment ]
    applanation tonometry

  4. Dynamics of augmentation index [ Time Frame: In 2 months after recruitment ]
    applanation tonometry


Secondary Outcome Measures :
  1. Dynamics of biological age [ Time Frame: In 2 months after recruitment ]
    Laboratory indicators


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04871802


Contacts
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Contact: Irina Strazhesko, MD, PhD Istrazhesko@gmail.com
Contact: Olga Tkacheva, MD, PhD +74991871254 rgnkc@rgnkc.ru

Locations
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Russian Federation
Russian Clinical Research Center for Gerontology
Moscow, Russian Federation, 129226
Sponsors and Collaborators
Pirogov Russian National Research Medical University
Investigators
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Principal Investigator: Irina Strazhesko, MD, PhD Clinical Reserach Center for Gerontology
More Information
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Responsible Party: Pirogov Russian National Research Medical University
ClinicalTrials.gov Identifier: NCT04871802    
Other Study ID Numbers: COVID-AQUA-1
First Posted: May 4, 2021    Key Record Dates
Last Update Posted: May 4, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pneumonia
Pneumonia, Viral
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
 Respiratory Tract Diseases
Taxifolin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents