NCT07695870

Brief Summary

Purpose of the study: Evaluation of the effects of dietary supplement Fitoavia in people with dyssynchrony Objectives of the study:

  1. 1.Assessment of the condition of patients with jet lag of 4 hours or more
  2. 2.Determination of the day of normalization of the circadian rhythm in each group
  3. 3.Assessing the quality of life of patients.
  4. 4.Assessment of the economic effectiveness of the therapy performed
  5. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 10, 2026

Completed
Last Updated

July 10, 2026

Status Verified

July 1, 2026

Enrollment Period

3 months

First QC Date

May 27, 2026

Last Update Submit

July 8, 2026

Conditions

Jet Lag DisorderJet LagJet Lag Type InsomniaCognition Improvement

Keywords

let lag, dyssynchrony syndrome

Outcome Measures

Primary Outcomes (2)

  • decreased summary of jet lag symphtoms

    day if symphtom decreased (daily measurement)

    From enrollment to the end of treatment (day 0 - day 7)

  • sleep duration

    each day patients will check the sleep duration time in hours and minutes

    Everyday from baseline, until the end of the study (day 0 - day 7)

Secondary Outcomes (2)

  • Questionairy level

    from enrolment to the end of the study (day 0 - day 7)

  • Cognition level

    From enrollment to the end of the treatment (day 0 - day 7)

Study Arms (2)

treatment

EXPERIMENTAL

recieved active components for jet lag treatment

Dietary Supplement: FitoaviaDiagnostic Test: Questionnaire and Physical ExamDiagnostic Test: cognition tests

Control

PLACEBO COMPARATOR

resieved the same looking capsules without active components

Dietary Supplement: PlaceboDiagnostic Test: Questionnaire and Physical ExamDiagnostic Test: cognition tests

Interventions

FitoaviaDIETARY_SUPPLEMENT

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

Also known as: Placebo, Questionaire, Cognition test, EQ-5D questionaire, Informed consent signing, Blood preasure measurement, Saturation, pulse
treatment
PlaceboDIETARY_SUPPLEMENT

Placebo contains no active components

Also known as: questionarie, BPM, weight, tall,
Control
Questionnaire and Physical ExamDIAGNOSTIC_TEST

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

Controltreatment
cognition testsDIAGNOSTIC_TEST

tests on spesial testing platform (Tests on the PC)

Controltreatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Voluntarily and personally signed informed consent form to participate in the study, before any of the research procedures.
  • Men and women over 18 years of age who have a time difference of more than four hours from their place of primary residence;
  • Confirmed flight in less than 24 hours
  • Previous adaptation to the new regimen for 3 or more days according to the screening questionnaire
  • Presence of three or more symptoms of jet lag on the screening questionnaire with a score above 5

You may not qualify if:

  • Currently taking adaptogens

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MiraxBioPharma

Moscow, Russia

Location

MeSH Terms

Conditions

Jet Lag Syndrome

Interventions

Oxygen SaturationPulseWeights and MeasuresPhysical Examination

Condition Hierarchy (Ancestors)

Chronobiology DisordersNervous System DiseasesSleep Disorders, Circadian RhythmDyssomniasSleep Wake DisordersTravel-Related IllnessSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

MetabolismHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaInvestigative TechniquesDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2026

First Posted

July 10, 2026

Study Start

October 1, 2025

Primary Completion

December 31, 2025

Study Completion

April 30, 2026

Last Updated

July 10, 2026

Record last verified: 2026-07

Locations

RU(1)