Efficacy and Safety of Cytoflavin® Used in Elderly Patients for the Prevention of Cognitive Decline After Major Surgery

PHASE3CompletedINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

June 2, 2017

Primary Completion Date

April 11, 2019

Study Completion Date

July 11, 2019

Conditions
Cognitive Dysfunction
Interventions
DRUG

Cytoflavin® solution

Single drip infusion of 20 ml of Cytoflavin® solution in 200 ml of 0.9%NaCl intravenously once a day

DRUG

Cytoflavin® enteric-coated tablet

2 tablets, orally, with 100 ml of drinking water, 30 minutes before meals, 2 times a day, with an interval of 8-10 hours (but no later than 18:00).

DRUG

Placebo solution

Single drip infusion of 20 ml of placebo solution in 200 ml of 0.9%NaCl intravenously once a day

DRUG

Placebo enteric-coated tablet

2 tablets, orally, with 100 ml of drinking water, 30 minutes before meals, 2 times a day, with an interval of 8-10 hours (but no later than 18:00).

Trial Locations (13)

Unknown

Regional Clinical Hospital № 3, Chelyabinsk

Central Clinical Hospital with a polyclinic of the Office of the President of the Russian Federation, Moscow

Alexandrovskaya City Hospital, Saint Petersburg

City Hospital №15, Saint Petersburg

City Hospital №38 named after N.A. Semashko, Saint Petersburg

City Hospital №40 of the Kurortny District, Saint Petersburg

Hospital for War Veterans, Saint Petersburg

I. P. Pavlov 1st St. Petersburg State Medical University, Saint Petersburg

Military Medical Academy named after S.M. Kirov, Saint Petersburg

Pokrovskaya City Hospital, Saint Petersburg

"GBUZ YAO Regional Clinical Hospital", Yaroslavl

"Research center of specialized types of medical care Ural Institute of Cardiology", Yekaterinburg

Ural State Medical University, Yekaterinburg

All Listed Sponsors
lead

POLYSAN Scientific & Technological Pharmaceutical Company

INDUSTRY

NCT03849664 - Efficacy and Safety of Cytoflavin® Used in Elderly Patients for the Prevention of Cognitive Decline After Major Surgery | Biotech Hunter | Biotech Hunter