Acute altitude sickness
Conditions
Interventions
The group using KXA:Use the KXA for 1 day before entering the oxygen chamber, 3 sprays 3 times a day. On the day of entering the chamber. Using KXA 1 time in the morning before entering the chamber (3
The group using placebo:Use the placebo for 1 day before entering the oxygen chamber, 3 sprays 3 times a day. On the day of entering the chamber. Using placebo 1 time in the morning before entering th
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy volunteers with plans to go to the plateau. male or female, The volunteers are between 18 and 55 years (including the boundary value) old; 2. The altitude of the main residence is less than or equal to 800 meters; 3. The volunteers did not go to plateau over 2,500m within 6 months; 4. Voluntary participation and written informed consent.
Exclusion criteria
Exclusion criteria: 1.Severe high-altitude reactions within 5 years, including high-altitude heart disease, high-altitude pulmonary edema, high-altitude cerebral edema, and high-altitude polycythemia. 2.Previously diagnosed cardiovascular or cerebrovascular diseases, or uncontrolled hypertension (systolic blood pressure >= 140 mmHg and/or diastolic blood pressure >= 90 mmHg at screening). 3.Clinically significant respiratory, digestive, liver, central nervous system, mental, metabolic, kidney diseases, anemia, or acute infections. 4.Mental disorders (including migraine, anxiety, depression, and insomnia). 5.Primary headache (migraine, tension-type headache, cluster headache, etc.) or secondary headache (headache related to infection, cerebrovascular diseases, etc.) within one month before screening. 6.LLSS score >= 1 at screening. 7.Oxygen saturation of the left index finger 2 times the upper limit of the normal range, or creatinine > upper limit of the normal range at screening. 9.Use of any drugs or non-drug interventions (including dietary supplements) to prevent or treat acute mountain sickness within 14 days before screening. 10.History of cardiopulmonary diseases, respiratory tract infection within 3 months. 11.Contraindications to MRI, or brain diseases detected by MRI. 12.Individuals with contraindications or allergies to the drugs used. 13.Pregnant, lactating, or women with positive pregnancy test results. 14.Participation in other interventional clinical studies within 3 months before screening. 15.Regular use of one or more medications daily. 16.Habits of smoking or excessive alcohol consumption. 17,Alcohol or coffee consumption within three days before screening. 18.Any other conditions that the investigator deems unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lake Louise Acute Mountain Sickness Score;Phytoneurological Function Tests+HRV; | — |
Secondary
| Measure | Time frame |
|---|---|
| Headache Visual Rating Scale;Processing Speed Scale;Executive Function Scale;Memory scale;Cardiopulmonary exercise testing;Eye tracking;Near Infrared;MRI;Vital signs; | — |
Countries
China
Contacts
Public ContactLei Chen
West China Hospital of Sichuan University
Outcome results
None listed