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

NCT07695870 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-07-10

No results posted yet for this study

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.

Conditions

  • Jet Lag Disorder
  • Jet Lag
  • Jet Lag Type Insomnia
  • Cognition Improvement

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)

Sponsors & Collaborators

  • MiraxBioPharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2025-12-31
Completion
2026-04-30

Countries

  • Russia

Study Locations

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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 NCT07695870 on ClinicalTrials.gov