Acute mountain sickness
Conditions
Interventions
experimental group:Melatonin, with a dosage of 2.24 mg, was administered orally one hour before bedtime on the day prior to the subject's rapid ascent to high altitude, at a dose of 1 tablet per admin
Control group:The placebo, identical in appearance to the trial drug but devoid of the active melatonin ingredient, was administered orally one hour before bedtime on the day preceding the subjects' r
Sponsors
Institute of Cardiovascular Diseases of PLA, Xinqiao Hospital, Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Those who live in the plains, aged over 18 years, male or female; 2. No history of entering high altitude (2500 meters above sea level); 3. Sign informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1. Menstrual, pregnant and breastfeeding women; 2. Smokers, alcohol drinkers and drug abusers; 3. Those with a clear history of drug allergies; 4. Those who have used various drugs (including traditional Chinese medicine) within 2 weeks before the test; 5. Those who have a history of blood donation or experimental blood collection within 3 months before enrollment; 6. Combined with severe cardiac, hepatic and renal dysfunction (heart function > grade 2, liver function > 2 times the upper limit of normal, Cr > upper limit of normal); 7. C-reactive protein, blood lactate, lactate clearance rate, and NT-proBNP test results exceeded the upper limit of normal; 8. Clinically significant fundus examination lesions or abnormalities; 9. Clinically significant digestive system diseases, mental diseases, and patients with metabolic diseases such as diabetes and hyperthyroidism; 10. Previous cardiovascular and cerebrovascular diseases; 11. Fatigue syndrome not caused by high altitude hypoxia; 12. Primary headache patients; 13. Vomiting caused by other reasons, such as reflex vomiting, vestibular disorder vomiting, neurological vomiting caused by digestive system diseases; 14. Allergic patients; 15. Those who have participated in clinical trials of other drugs within 1 month; 16. Those who are taking blood-activating, immune-enhancing and antioxidant drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Acute Mountain Sickness (AMS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood routine examination;Routine urine test;Blood biochemistry markers;Ambulatory ECG;Ambulatory blood pressure;Echocardiography;Chest X ray;Oxygen saturation;Heart rate;Serum melatonin;Fundus examination;CRP;Nitric oxide;Serum lactic acid;Lactate clearance rate;NT-pro BNP;Other laboratory biomarker;Symptom evaluation of AMS; | — |
Countries
China
Contacts
Public ContactHuang Lan
Institute of Cardiovascular Diseases of PLA, Xinqiao Hospital, Army Medical University
Outcome results
None listed