EleVation carE: a Randomized Controlled Trial on the Prevention of Acute Mountain Sickness With S… (NCT06531161) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
EleVation carE: a Randomized Controlled Trial on the Prevention of Acute Mountain Sickness With Suxiao Jiuxin Pill
168 participantsStarted 2024-08
Plain-language summary
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.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion Criteria:
* 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;
* Voluntary participation with written informed consent.
Exclusion Criteria:
* 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;
* Subjects with insomnia, anxiety, depression or a history of motion sickness or airplane sickness;
* Subjects with Lake Louise Score ≥ 2 at screening;
* Subjects with left index finger oxyg…
What they're measuring
1
Incidence rate of AMS assessed by LLS system on the next morning of arrival day at high altitude between Suxiao Jiuxin Pill and Placebo groups.
Timeframe: The next morning of arrival day at high altitude