EleVation carE: a Randomized Controlled Trial on the Prevention of Acute Mountain Sickness With Suxiao Jiuxin Pill
NCT Number: NCT06531161
Acronym: EVEREST
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Acute Mountain Sickness
Interventions: DRUG: Suxiao Jiuxin Pill|DRUG: Placebo
Sponsor: Peking University First Hospital
Collaborators: Tibet Autonomous Region Hospital of Traditional Tibetan Medicine
Sex: ALL
Age: ADULT
Enrollment: 168
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08
Completion Date: 2025-09

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.

Primary Outcome Measures: 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., The next morning of arrival day at high altitude
Secondary Outcome Measures: 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., Arrival day to Day 3 after high altitude exposure|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., Day 4 at sea level to Day 3 after high altitude exposure|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., Arrival day to Day 3 after high altitude exposure|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., The next morning of arrival day at high altitude|Mean AMS Clinical Functional Score after arrival between Suxiao Jiuxin Pill and Placebo groups., Self-reported AMS Clinical Functional Score is used to evaluate the impact of AMS symptoms on overall function at high altitude. The difference will be compared in the AMS Clinical Functional Scores after arrival between Suxiao Jiuxin Pill and Placebo groups., Arrival day to Day 3 after high altitude exposure|Blood oxygen saturation (SpO2) from sea level to high altitude between Suxiao Jiuxin Pill and Placebo groups., Blood oxygen saturation (SpO2) will be tested using a pulse oximetry and measured from the left index finger. SpO2 will be tested for 3 times daily by staff before breakfast, before lunch, and before sleep from Day 4 at sea level to Day 3 after high altitude exposure. The difference will be compared in SpO2 from sea level to high altitude between Suxiao Jiuxin Pill and Placebo groups., Day 4 at sea level to Day 3 after high altitude exposure|Incidence rate of AMS symptoms requiring additional treatment during and after high altitude exposure between Suxiao Jiuxin Pill and Placebo groups., AMS symptoms requiring additional treatment is defined as high-altitude cerebral edema, high-altitude pulmonary edema, and severe AMS symptoms (nausea, vomiting, fatigue, dizziness, etc.). The difference will be compared in the incidence rates of AMS symptoms requiring additional treatment during and after high altitude exposure between Suxiao Jiuxin Pill and Placebo groups., Arrival day to Day 3 after high altitude exposure|Acute Mountain Sickness Symptom Scale and Score after arrival between Suxiao Jiuxin Pill and Placebo groups., Acute Mountain Sickness Symptom Scale and Score is a scoring system which evaluates symptoms of headache, vomiting, dizziness, nausea, palpitation, shortness of breath, chest tightness, dizziness, insomnia, drowsiness, loss of appetite, abdominal distention, diarrhea, constipation, cyanosis of the lips, numbness of the hands and feet. The Acute Mountain Sickness Symptom Scale and Score assessments will be conducted before breakfast and before sleep from arrival day to Day 3 after high altitude exposure. The difference will be compared in the mean Acute Mountain Sickness Symptom Scale and Score after arrival between Suxiao Jiuxin Pill and Placebo groups., Arrival day to Day 3 after high altitude exposure|Rate of oxygen treatment after arrival between Suxiao Jiuxin Pill and Placebo groups., Oxygen treatment will be given according to the participants' requirement or care providers' suggestion. The difference will be compared in the rates of oxygen treatment after arrival between Suxiao Jiuxin Pill and Placebo groups., Arrival day to Day 3 after high altitude exposure
Other Outcome Measures: 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., Baseline, Day 4 at sea level, arrival day, Day 3 after high altitude exposure|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., Baseline, the next day after arrival, Day 3 after arrival|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., Baseline, the next day after arrival, Day 3 after arrival|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., Baseline, Day 3 to Day 5 at sea level, the next day after arrival to Day 3 after arrival|Change of carotid-femoral pulse wave velocity (cfPWV) at high altitude from baseline between Suxiao Jiuxin Pill and Placebo groups., cfPWV 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 change of cfPWV at high altitude from baseline between Suxiao Jiuxin Pill and Placebo groups., Baseline, the next day after arrival, Day 3 after arrival|Change of mean velocity of middle cerebral artery at high altitude from baseline between Suxiao Jiuxin Pill and Placebo groups., Mean velocity of middle cerebral artery will be measured using transcranial Doppler ultrasound at baseline (at sea level), the next day after arrival, and Day 3 after arrival. The difference will be compared in the changes of mean velocity of middle cerebral artery at high altitude from baseline between Suxiao Jiuxin Pill and Placebo groups., Baseline, the next day after arrival, Day 3 after arrival