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COMPLETED
NCT07695870
NA

A Study on the Effectiveness of a Dietary Supplement FitoAvia for Jet Lag

Sponsor: MiraxBioPharma

View on ClinicalTrials.gov

Summary

Purpose of the study: Evaluation of the effects of dietary supplement Fitoavia in people with dyssynchrony Objectives of the study: 1. Assessment of the condition of patients with jet lag of 4 hours or more 2. Determination of the day of normalization of the circadian rhythm in each group 3. Assessing the quality of life of patients. 4. Assessment of the economic effectiveness of the therapy performed 5. Evaluation of the results of daily software testing for "staff" of at least 12 people from each group Randomization Block randomization with stratification. Randomization sheets will be provided prior to the start of the study. Sample size Total number of patients included in the study: up to 120. Study groups Group 2 - at least 60 patients in each group (Fitoavia/Placebo) with stratification within each group: Group 1, patients receiving: Fitoavia. Group 2 patients who received: Placebo. Stratification implies uniform inclusion of patients according to the amount of jet lag.

Official title: Double-blind, Randomized, Placebo-controlled Scientific Study of the Comparative Effectiveness of Fitoavia Dietary Supplement in People With Dyssynchrony Syndrome.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-10-01

Completion Date

2026-04-30

Last Updated

2026-07-10

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

Fitoavia

Interventional: participants are assigned prospectively to an intervention or interventions according to a protocol to evaluate the effect of the intervention(s) on biomedical or other health related outcomes; EQ-5D questionaire, placebo group, cognition tests

DIETARY_SUPPLEMENT

Placebo

Placebo contains no active components

DIAGNOSTIC_TEST

Questionnaire and Physical Exam

EQ-5D, measurements of weight, BMI, blood pressuarem temperature, oxigenation, sleep time duration, AE.

DIAGNOSTIC_TEST

cognition tests

tests on spesial testing platform (Tests on the PC)

Locations (1)

MiraxBioPharma

Moscow, Russia