Acute mountain sickness
Conditions
Interventions
Placebo group:After the aircraft lands on the plateau, 3 times a day (around 14:00 in the afternoon, around 18:00 in the evening, and around 22:00 before sleep), 3 sprays each time, sublingual adminis
Intervention group:After the aircraft lands on the plateau, 3 sprays (approximately at 14:00 in the afternoon, 18:00 in the evening, and 22:00 before bedtime) should be administered daily for 72 hours
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 50 years old (inclusive), healthy volunteers, both genders. 2. Residence: Continuous residence in plain areas (altitude =6 months. 3. High-altitude exposure: No exposure to altitudes >2500 m within 6 months prior to enrollment. 4. Smoking and secondhand smoke: No history of smoking (including e-cigarettes) within 6 months prior to enrollment, and no long-term exposure to secondhand smoke. 5. Body mass index (BMI): Between 19.0 and 27.9 kg/m². 6. Oral condition: Oral mucosa intact, without lesions or active inflammation that could affect sublingual administration. 7. Contraception: Female subjects of childbearing potential must have a negative pregnancy test and agree to use effective contraceptive measures during the study period. 8. Informed consent: Agree to participate in this study and have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Previous history of HAPE, HACE, or diagnosed high-altitude heart disease or high-altitude polycythemia. 2. Diagnosed coronary heart disease, stroke, uncontrolled hypertension (systolic blood pressure >=140 mmHg and/or diastolic blood pressure >=90 mmHg at screening), or cardiovascular disease judged clinically significant by the investigator. 3. Unstable or uncontrolled chronic respiratory, digestive, hepatic, renal, metabolic, or hematological diseases (including anemia: hemoglobin =2 at screening, or resting SpO2 2× upper limit of normal (ULN), total bilirubin >1.5× ULN, or creatinine >ULN at screening; hs-CRP >ULN. 7. Oral mucosal damage, active ulcers, or other conditions affecting sublingual administration. 8. Use of any prescription drugs, traditional Chinese medicines, or health supplements for prevention/relief of AMS within 14 days prior to screening. 9. Known allergy to any component of the investigational product, or presence of contraindications to its use. 10. Pregnant or lactating women, or women of childbearing potential with a positive pregnancy test and not using effective contraception. 11. Participation in other interventional studies, blood donation >400 mL, major trauma, or surgery within 3 months prior to screening. 12. Currently participating in another interventional clinical trial. 13. Judged by the investigator as unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Lake Louise Scoring System (LLSS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Headache Visual Analogue Scale (VAS) score;Routine clinicala assessments: body composition analysis, SpO2, resting heart rate, blood pressure, Pittsburgh Sleep Quality Index (PSQI), Mini-Mental State Examination (MMSE), Montreal Cognitive;Multimodal baseline assessment of brain and cardiopulmonary function: fNIRS, EEG, eye tracking, electrogastrography, cardiopulmonary exercise testing (CPET), etc.; To explore the correlations between;Incidence of adverse events and adverse reactions; | — |
Countries
China
Contacts
Public ContactChen Lei
West China Hospital of Sichuan University
Outcome results
None listed