The aim of this randomized, controlled trial is to evaluate the safety and efficacy of Suxiao Jiuxin Pills for prevention of acute mountain sickness (AMS) after high altitude exposure in healthy volunteers, and its influences on physiological indicators before and after high altitude exposure.
Healthy volunteers, aged 18-55 years old (including boundary values);
Female volunteers weighing ≥45.0 kg and male volunteers weighing ≥50.0 kg, with a body mass index (BMI) between 19.0 and 28.0 kg/m2 (including boundary values) (BMI=weight kg/height m2);
Primary residence at an altitude of <500 meters above sea level;
Not ascending to an altitude >2500 meters in the 6 months prior to the screening period;
Subjects with previous severe high altitude sickness such as high altitude heart disease, high altitude pulmonary edema, high altitude cerebral edema, and high altitude erythrocytosis;
Subjects with established cardiovascular or cerebrovascular disease or uncontrolled hypertension (systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg at screening);
Subjects with clinically significant respiratory disease, digestive disease, liver disease, central nervous system disease, psychiatric disease, metabolic disease, renal disease, anemia, or acute infection;
Subjects with primary headache (migraine, tension headache, cluster headache, etc.) or secondary headache (headache associated with infection, cerebrovascular, etc.) within 1 month prior to screening;
Peking University First Hospital
Lead sponsor
Tibet Autonomous Region Hospital of Traditional Tibetan Medicine
Collaborator