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;
Parallel
Suxiao Jiuxin Pill
DrugSuxiao Jiuxin Pill is a traditional Chinese medicine compound composed of Ligusticum Wallichii and Borneo Camphorwood, and its clinical safety has been confirmed. Traditional Chinese medicine theory believes that Suxiao Jiuxin Pill has the effects of promoting qi and blood circulation, removing blood stasis and relieving pain, which may help alleviate symptoms of AMS.
Placebo
DrugPlacebo is made of less than 10% of the amount of Suxiao Jiuxin Pill, with similar dosage, odor, and taste.
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.
AMS was defined as LLS score ≥ 3 with headache and at least one of the symptoms of nausea or vomiting, fatigue, dizziness. The difference in incidence rate of AMS on the next morning of arrival day at high altitude is pre-specified as primary efficacy endpoint between Suxiao Jiuxin Pill and Placebo groups.
Incidence rate of AMS assessed by LLS system after arrival at high altitude between Suxiao Jiuxin Pill and Placebo groups.
LLS assessments will be conducted before breakfast and before sleep after arrival at high altitude. The difference will be compared in the total incidence rates of AMS assessed by LLS after arrival between Suxiao Jiuxin Pill and Placebo groups.
Baseline-corrected LLS after high altitude exposure between Suxiao Jiuxin Pill and Placebo groups.
LLS assessments will be conducted before breakfast and before sleep on Day 4 (at sea level) and the days after high altitude exposure. LLS on Day 4 will be used as baseline scores. The difference will be compared in the mean baseline-corrected LLS between Suxiao Jiuxin Pill and Placebo groups.
Area under the curve (AUC) of LLS in the mean LLS score-time profile after arrival between Suxiao Jiuxin Pill and Placebo groups.
LLS assessments will be conducted before breakfast and before sleep on days after arrival. The AUC of LLS in the mean LLS score-time profile after arrival will be compared between Suxiao Jiuxin Pill and Placebo groups.
Incidence rate of moderate and above AMS on the next morning of arrival at high altitude between Suxiao Jiuxin Pill and Placebo groups.
Moderate and above AMS is defined as LLS score ≥ 6. The difference will be compared in the incidence rates of moderate and above AMS on the next morning of arrival between Suxiao Jiuxin Pill and Placebo groups.
Change of blood pressure and heart rate at high altitude from baseline between Suxiao Jiuxin Pill and Placebo groups.
Blood pressure and heart rate assessments will be conducted before breakfast, before lunch and before sleep at baseline and Day 4 at sea level, arrival day to Day 3 after high altitude exposure. The difference will be compared in the changes of blood pressure and heart rate at high altitude from baseline between Suxiao Jiuxin Pill and Placebo groups.
Change of brain natriuretic peptide (BNP) at high altitude from baseline between Suxiao Jiuxin Pill and Placebo groups.
BNP will be measured at baseline (at sea level), the next day after arrival and Day 3 after arrival. The difference will be compared in the changes of BNP at high altitude from baseline between Suxiao Jiuxin Pill and Placebo groups.
Change of pulmonary artery systolic pressure estimated by echocardiography at high altitude from baseline between Suxiao Jiuxin Pill and Placebo groups.
Pulmonary artery systolic pressure will be estimated by echocardiography at baseline (at sea level), the next day after arrival and Day 3 after arrival. The difference will be compared in the change of pulmonary artery systolic pressures at high altitude from baseline between Suxiao Jiuxin Pill and Placebo groups.
Rate of sleep disturbances at high altitude between Suxiao Jiuxin Pill and Placebo groups.
Sleep questionaires, including Athens Insomnia Scale and Epworth Sleepiness Scale, will be recorded at mornings of baseline, and Day 3 to Day 5 at sea level, and the next day after arrival to Day 3 after arrival. The difference will be compared in the rates of sleep disturbances at high altitude between Suxiao Jiuxin Pill and Placebo groups.
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Peking University First Hospital
Lead sponsor
Tibet Autonomous Region Hospital of Traditional Tibetan Medicine
Collaborator
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