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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04871802
• Other study ID #: COVID-AQUA-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 10, 2021
• Est. completion date: October 1, 2021

Study information

• Verified date: March 2021
• Source: Pirogov Russian National Research Medical University
• Contact: Irina Strazhesko, MD, PhD
• Email: Istrazhesko[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid19
• Pneumonia

Intervention

Dietary Supplement:
• Taxifolin Aqua
Dietary supplement

Locations

Country	Name	City	State
Russian Federation	Russian Clinical Research Center for Gerontology	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Pirogov Russian National Research Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamics of spirometry indices	spirometry	In 2 months after recruitment
Primary	Dynamics of ECHO CG	ECHO CG	In 2 months after recruitment
Primary	Dynamics of pulse wave velocity	applanation tonometry	In 2 months after recruitment
Primary	Dynamics of augmentation index	applanation tonometry	In 2 months after recruitment
Secondary	Dynamics of biological age	Laboratory indicators	In 2 months after recruitment