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Purpose of the study: Evaluation of the effects of dietary supplement Fitoavia in people with dyssynchrony
Objectives 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment | Experimental | recieved active components for jet lag treatment |
|
| Control | Placebo Comparator | resieved the same looking capsules without active components |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fitoavia | Dietary 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Questionairy level | EQ-5D daily level | from enrolment to the end of the study (day 0 - day 7) |
| Cognition level | Tests on the PC (makes daily) |
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Inclusion Criteria:
• Voluntarily and personally signed informed consent form to participate in the study, before any of the research procedures.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MiraxBioPharma | Moscow | Russia |
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| ID | Term |
|---|---|
| D020179 | Jet Lag Syndrome |
| ID | Term |
|---|---|
| D021081 | Chronobiology Disorders |
| D009422 | Nervous System Diseases |
| D020178 | Sleep Disorders, Circadian Rhythm |
| D020920 | Dyssomnias |
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| ID | Term |
|---|---|
| D000089382 | Oxygen Saturation |
| D011674 | Pulse |
| D014894 | Weights and Measures |
| D010808 | Physical Examination |
| ID | Term |
|---|---|
| D008660 | Metabolism |
| D006439 | Hemodynamics |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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|
|
| Placebo | Dietary Supplement | Placebo contains no active components |
|
|
| Questionnaire and Physical Exam | Diagnostic Test | EQ-5D, measurements of weight, BMI, blood pressuarem temperature, oxigenation, sleep time duration, AE. |
|
| cognition tests | Diagnostic Test | tests on spesial testing platform (Tests on the PC) |
|
| From enrollment to the end of the treatment (day 0 - day 7) |
| D012893 | Sleep Wake Disorders |
| D000076082 | Travel-Related Illness |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D008919 | Investigative Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |