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Cytoflavin in the Complex Rehabilitation of Stroke Patients

NCT05935787 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-04-14

No results posted yet for this study

Summary

It is known that the acute period of stroke occurs is accompanied by oxidative stress, when intense generation of reactive oxygen species (ROS) have a toxic effect, which causes oxidative degradation of proteins, lipids, nucleic acids. Antioxidants may have a positive effect on the processes of reparation, remodeling and neuroplasticity, thus improving the effectiveness of post-stroke rehabilitation. The adjunctive use of drug therapy that improves neuroplasticity may promote accelerated motor learning, which underlies the effects of exercise therapy and physical therapy, speech therapy, and sessions with a psychologist or occupational therapist. CYTOFLAVIN® is a combination of succinic acid, riboflavin, nicotinamide and inosine (riboxin) which has antihypoxic and antioxidant effects. The study hypothetizes that this neurometabolic drug will facilitate learning in stroke survivors and help to acquire new cognitive or motor skills necessary for daily living. The study will be conducted in two parallel groups of stroke survivors: the experimental group will be treated with Cytoflavin along with ohysical rehabilitation, the control group will receive standard rehabilitation course.

Conditions

Interventions

DRUG

Cytoflavin (Inosine + Nicotinamide + Riboflavin + Succinic Acid)

Cytoflavin (Inosine + Nicotinamide + Riboflavin + Succinic Acid), 20 ml (two ampoules of 10 ml each) once a day intravenously in a dilution of 200 ml of 0.9% sodium chloride solution at a rate 3-4 ml/min, for 15 days + Cytoflavin ((Inosine + Nicotinamide + Riboflavin + Succinic Acid), 2 tablets 2 times a day, for 25 days

DRUG

Placebo

Placebo, 20 ml (two ampoules of 10 ml each) once a day intravenously in a dilution of 200 ml of 0.9% sodium chloride solution at a rate 3-4 ml / min, for 15 days + Placebo, 2 tablets 2 times a day, for 25 days

Sponsors & Collaborators

  • POLYSAN Scientific & Technological Pharmaceutical Company

    lead INDUSTRY

Principal Investigators

  • Alexey Shmonin, Prof · First St. Petersburg State Medical University named after I.P. Pavlov

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-30
Primary Completion
2024-06-26
Completion
2024-12-07

Countries

  • Russia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05935787 on ClinicalTrials.gov