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In the period from June 2021 to June 2022, a prospective clinical study will be conducted in the Republic of Kazakhstan with economy class passengers traveling by plane with a minimum flight period of 5-7 flight hours in the territory of the Republic of Kazakhstan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The study Group | Experimental |
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| Control group | Active Comparator | Melatonin® 5 mg per os 2 hours before bedtime on the day of arrival for 3-4 days. |
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| Explanatory group: | No Intervention | 12 participants without any intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Citicoline | Drug | Citicoline 500 mg (Vitaae®) per os |
|
| Measure | Description | Time Frame |
|---|---|---|
| Urine Specific Gravity | Urine Specific Gravity test | 24 hours before the flight |
| SpO2 level | Pulse oximetry | 24 hours before the flight |
| Ultrasound examination | Ultrasound examination of the veins of the lower limbs | 24 hours before the flight |
| The Liverpool Jet Lag questionnaire | Changes from normal (0 to 5) while jetlag rating was recorded on a scale from 0 = insignificant jetlag to 10 = severe jetlag | 24 hours before the flight |
| Lake Louise Acute Mountain Sickness Assessment System | Mild acute mountain sicknessas 3-5 points, moderate acute mountain sickness as 6-9 points, and severe acute mountain sickness as 10-12 points | 24 hours before the flight |
| Neuropsychological tests (Trail Making Test, Wechsler Memory Scale - IV, Free recall | Word, color, and color-word T-Scores of 40 or less are considered "low." Word, color, and color-word T-Scores above 40 or are considered "normal." In order for one score to be considered "higher" or "lower" than another, a 10 point or greater T score difference is required. | 24 hours after the flight |
| Measure | Description | Time Frame |
|---|---|---|
| The Liverpool Jet Lag questionnaire (LJLQ) | Changes from normal (0 to 5) while jetlag rating was recorded on a scale from 0 = insignificant jetlag to 10 = severe jetlag | 24 hours after the flight |
| Lake Louise Acute Mountain Sickness Assessment System |
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Study participants (Volunteers) will be recruited through media, advertisements and announcements. Prior to the study, study participants will receive written and oral explanations of the study protocols, and written informed consent will be obtained from each study participant. All potential research participants will undergo medical and psychological selection. The components, stages of selection are almost the same as those of general professional selection: the first stage is professiography / psychogram, the second stage is psychodiagnostics, the third stage is assessment and forecasting, and the fourth stage is decision making. Selection will assess the ability of participants to perform complex sequential actions.
Inclusion criterion:
In addition, study participants will be asked not to limit their caffeine intake from their daily intake, but only water is allowed 4 hours before the neuropsychological testing. Participants in the study should not hmedical/medicallane in the last two weeks prior to the start of the study, nor should they consume alcohol during the study.
Exclusion criterion:
All participants must be free of a history of venous thrombosis, antithrombotic or anticoagulant medications and oral contraceptives and / or any other drugs that interfere with blood coagulation (i.e. warfarin, coumadin) for at least 2 months prior to study initiation, and sign a consent to refrain from taking medications that may affect coagulation, such as aspirin or non-steroidal anti-inflammatory drugs, within 3 days after the flight, unless there is a medical / medical need.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arman Lurye | Contact | +7 701 765 2196 | arman@lurye.clinic | |
| Dinara Dzhumanbayeva | Contact | +7 701 765 2196 | dinara@lurye.clinic |
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| Cytochrome C6 | Drug | Cytochrome10 mg per os |
|
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| Sodium Chloride Oral Product | Drug | Sodium Chloride (NaCl) 2.6 g. per os |
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| Potassium Chloride Oral Product | Drug | Potassium Chloride 1.5 g per os |
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| Sodium Citrate Oral Product | Drug | Sodium Citrate 2.90 g per os |
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| Dextrose Oral Tablet, Chewable | Drug | Dextrose 13.5 g per os |
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| Domperidone Oral Product | Drug | Domperidone 1 tablet per os |
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| Simethicone | Drug | 3-4 capsules per os |
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| Acetylsalicylic acid | Drug | Acetylsalicylic acid 150 mg per os |
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| Magnesium hydroxide | Drug | magnesium hydroxide 30 mg per os |
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| Probiotic Formula | Drug | 1 capsule per os. |
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| Melatonin 5 mg | Drug | Melatonin 5 mg per os. |
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Mild acute mountain sicknessas 3-5 points, moderate acute mountain sickness as 6-9 points, and severe acute mountain sickness as 10-12 points
| 24 hours after the flight |
| The Stroop Test | Word, color, and color-word T-Scores of 40 or less are considered "low." Word, color, and color-word T-Scores above 40 or are considered "normal." In order for one score to be considered "higher" or "lower" than another, a 10 point or greater T score difference is required. | 24 hours after the flight |
| Urine Specific Gravity | Urine Specific Gravity test | 24 hours after the flight |
| SpO2 level | Pulse oximetry | 24 hours before the flight |
| ID | Term |
|---|---|
| D003566 | Cytidine Diphosphate Choline |
| D045365 | Cytochromes c6 |
| D045304 | Cytochromes c |
| D011189 | Potassium Chloride |
| D000077559 | Sodium Citrate |
| D005947 | Glucose |
| D004294 | Domperidone |
| D012841 | Simethicone |
| D001241 | Aspirin |
| D008276 | Magnesium Hydroxide |
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D002794 | Choline |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
| D003565 | Cytidine Diphosphate |
| D003597 | Cytosine Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
| D003574 | Cytochrome c Group |
| D003580 | Cytochromes |
| D045762 | Enzymes and Coenzymes |
| D006420 | Hemeproteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017680 | Potassium Compounds |
| D019343 | Citric Acid |
| D002951 | Citrates |
| D014233 | Tricarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D010880 | Piperidines |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004129 | Dimethylpolysiloxanes |
| D012828 | Silicones |
| D012833 | Siloxanes |
| D017646 | Organosilicon Compounds |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D017616 | Magnesium Compounds |
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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