[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556903":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":37,"locations":26,"responsibleParty":43,"collaborators":45,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":26,"studyType":64,"phases":65,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":73,"whyStopped":26,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":26},{"fullName":5,"class":6},"Peking University First Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: Suxiao Jiuxin Pill group","EXPERIMENTAL","Participants who are randomly assigned to Suxiao Jiuxin Pill group will receive Suxiao Jiuxin Pills (6 pills per time, 3 times a day, taken sublingually) for 4 days at sea level and another 3 days at high altitude.",[13],"Drug: Suxiao Jiuxin Pill",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo: Placebo group","PLACEBO_COMPARATOR","Participants who are randomly assigned to Placebo group will receive placebo (6 pills per time, 3 times a day, taken sublingually) for 4 days at sea level and another 3 days at high altitude.",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Suxiao Jiuxin Pill","Suxiao 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.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","Placebo is made of less than 10% of the amount of Suxiao Jiuxin Pill, with similar dosage, odor, and taste.",[15],[32,35],{"name":33,"affiliation":5,"role":34},"Yong Huo, M.D.","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":5,"role":34},"Yan Zhang, M.D.",[38],{"name":39,"role":40,"phone":41,"phoneExt":26,"email":42},"Kaiyin Li, M.D.","CONTACT","010-83575389","kaiyin0313@foxmail.com",{"type":44,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[46],{"name":47,"class":48},"Tibet Autonomous Region Hospital of Traditional Tibetan Medicine","UNKNOWN","100556903","phase-2-elevation-care-a-randomized-controlled-trial-on-the-prevention-of-acute-mountain-sickness-with-suxiao-jiuxin-pill-100556903",false,"NCT06531161","EleVation carE: a Randomized Controlled Trial on the Prevention of Acute Mountain Sickness With Suxiao Jiuxin Pill","Safety and Efficacy of Suxiao Jiuxin Pill for Prevention of Acute Mountain Sickness: a Randomized Controlled Trial","EVEREST","Inclusion Criteria:\n\n* Healthy volunteers, aged 18-55 years old (including boundary values);\n* 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\u002Fm2 (including boundary values) (BMI=weight kg\u002Fheight m2);\n* Primary residence at an altitude of \\\u003C500 meters above sea level;\n* Not ascending to an altitude \\>2500 meters in the 6 months prior to the screening period;\n* Voluntary participation with written informed consent.\n\nExclusion Criteria:\n\n* 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;\n* Subjects with established cardiovascular or cerebrovascular disease or uncontrolled hypertension (systolic blood pressure ≥ 140mmHg and\u002For diastolic blood pressure ≥ 90mmHg at screening);\n* Subjects with clinically significant respiratory disease, digestive disease, liver disease, central nervous system disease, psychiatric disease, metabolic disease, renal disease, anemia, or acute infection;\n* 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;\n* Subjects with insomnia, anxiety, depression or a history of motion sickness or airplane sickness;\n* Subjects with Lake Louise Score ≥ 2 at screening;\n* Subjects with left index finger oxygen saturation \\\u003C95% at screening;\n* Subjects with alanine aminotransferase or aspartate aminotransferase \\> 2 times the upper limit of the normal range, or creatinine \\> upper limit of the normal range at screening;\n* Subjects with hypersensitive C-reactive protein \\> upper limit of normal range at screening;\n* Subjects with history of surgery or blood donation within 3 months prior to screening;\n* Subjects with any medication or non-pharmacological intervention (including dietary supplements) to prevent or treat acute mountain sickness within 14 days prior to screening;\n* Smoking ≥20 cigarettes per day within 3 months prior to screening;\n* Contraindications to the use of Suxiao Jiuxin Pill, such as allergies;\n* Women who are pregnant, breastfeeding, or have a positive pregnancy test (human chorionic gonadotropin test);\n* Alcohol abuse \\[more than 28 standard units of alcohol per week (1 standard unit contains 14 g of alcohol, e.g., 360 mL of beer, 45 mL spirit with 40% alcohol by volume, or 150 mL of wine)\\] or substance abuse within 6 months prior to screening;\n* Participation in another interventional clinical study within 3 months prior to screening;\n* Other conditions, in the opinion of the investigators, make participation in this study inappropriate.",true,"ALL","18 Years","55 Years",{"count":62,"type":63},168,"ESTIMATED","INTERVENTIONAL",[66,67],"PHASE2","PHASE3","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.",[70],"Acute Mountain Sickness",[70,23,72],"Traditional Chinese Medicine","NOT_YET_RECRUITING","2024-08-08",{"date":76,"type":77},"2024-08-12","ACTUAL",{"date":79,"type":63},"2024-08",{"date":81,"type":63},"2025-09",{"name":5,"class":6}]