Jet Lag DisorderNCT07695870
A Study on the Effectiveness of a Dietary Supplement FitoAvia for Jet Lag
A study testing Fitoavia, Questionnaire and Physical Exam and cognition tests in people with Jet Lag Disorder and Jet Lag, run by MiraxBioPharma at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Jet Lag Disorder, Jet Lag, Jet Lag Type Insomnia
- What is being tested?
- Fitoavia, Questionnaire and Physical Exam and cognition tests
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteRussia
- Study dates
- 1 Oct 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- • Currently taking adaptogens
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Randomized, Placebo-controlled Scientific Study of the Comparative Effectiveness of Fitoavia Dietary Supplement in People With Dyssynchrony Syndrome.
Purpose of the study: Evaluation of the effects of dietary supplement Fitoavia in people with dyssynchrony
Objectives of the study:
Read more
- Assessment of the condition of patients with jet lag of 4 hours or more
- Determination of the day of normalization of the circadian rhythm in each group
- Assessing the quality of life of patients.
- Assessment of the economic effectiveness of the therapy performed
- 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.
- Being tested
- Fitoavia, Placebo, Questionnaire and Physical Exam, cognition tests
- Keywords
- let lag, dyssynchrony syndrome
- Medical subject headings
- Jet Lag Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FitoaviaDietary supplement
Also called Placebo, Questionaire, Cognition test, EQ-5D questionaire
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
PlaceboDietary supplement
Also called questionarie, BPM, weight, tall,
Placebo contains no active components
Questionnaire and Physical ExamDiagnostic test
EQ-5D, measurements of weight, BMI, blood pressuarem temperature, oxigenation, sleep time duration, AE.
cognition testsDiagnostic test
tests on spesial testing platform (Tests on the PC)
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | recieved active components for jet lag treatment Receives: Dietary Supplement: Fitoavia; Diagnostic Test: Questionnaire and Physical Exam; Diagnostic Test: cognition tests |
| Control | Placebo comparator | resieved the same looking capsules without active components Receives: Dietary Supplement: Placebo; Diagnostic Test: Questionnaire and Physical Exam; Diagnostic Test: cognition tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
decreased summary of jet lag symphtoms
day if symphtom decreased (daily measurement)
Measured: 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
Measured: Everyday from baseline, until the end of the study (day 0 - day 7)
Secondary outcomes (2)
Questionairy level
EQ-5D daily level
Measured: from enrolment to the end of the study (day 0 - day 7)
Cognition level
Tests on the PC (makes daily)
Measured: From enrollment to the end of the treatment (day 0 - day 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start1 Oct 2025
- Primary completion31 Dec 2025
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jet Lag DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- MiraxBioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695870
- Sponsor's protocol ID
- Fit-Lag-211
- Status last verified
- Jul 2026
- First submitted
- 27 May 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Placebo-controlled Scientific Study of the Comparative Effectiveness of Fitoavia Dietary Supplement in People With Dyssynchrony Syndrome.
- ClinicalTrials.gov ID
- NCT07695870
- Acronym / sponsor ID
- Fit-Lag-211
- Keywords
- let lag, dyssynchrony syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- MiraxBioPharmaIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose of the study: Evaluation of the effects of dietary supplement Fitoavia in people with dyssynchrony
Objectives of the study:
- Assessment of the condition of patients with jet lag of 4 hours or more
- Determination of the day of normalization of the circadian rhythm in each group
- Assessing the quality of life of patients.
- Assessment of the economic effectiveness of the therapy performed
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Dietary Supplement: Fitoavia, Diagnostic Test: Questionnaire and Physical Exam, Diagnostic Test: cognition testsrecieved active components for jet lag treatment |
| Control | Placebo comparator | Dietary Supplement: Placebo, Diagnostic Test: Questionnaire and Physical Exam, Diagnostic Test: cognition testsresieved the same looking capsules without active components |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Voluntarily and personally signed informed consent form to participate in the study, before any of the research procedures.
Key exclusion criteria (1 listed)
- • Currently taking adaptogens
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FitoaviaAlso: Placebo, Questionaire, Cognition test, EQ-5D questionaireInterventional: 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 | treatment |
| PlaceboAlso: questionarie, BPM, weight, tall,Placebo contains no active components | Dietary supplement | Control |
| Questionnaire and Physical ExamEQ-5D, measurements of weight, BMI, blood pressuarem temperature, oxigenation, sleep time duration, AE. | Diagnostic test | Control, treatment |
| cognition teststests on spesial testing platform (Tests on the PC) | Diagnostic test | Control, treatment |
Primary outcome
decreased summary of jet lag symphtoms
Time frame: From enrollment to the end of treatment (day 0 - day 7)
day if symphtom decreased (daily measurement)
sleep duration
Time frame: Everyday from baseline, until the end of the study (day 0 - day 7)
each day patients will check the sleep duration time in hours and minutes
2 secondary outcomes
Questionairy level
Time frame: from enrolment to the end of the study (day 0 - day 7)
Cognition level
Time frame: From enrollment to the end of the treatment (day 0 - day 7)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitoavia, Questionnaire and Physical Exam and cognition tests in people with Jet Lag Disorder and Jet Lag, run by MiraxBioPharma at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
decreased summary of jet lag symphtoms (time frame: From enrollment to the end of treatment (day 0 - day 7)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.