Acute Mountain SicknessPhase 2/3EVERESTNCT06531161
EleVation carE: a Randomized Controlled Trial on the Prevention of Acute Mountain Sickness With Suxiao Jiuxin Pill
A Phase 2/3 study testing Suxiao Jiuxin Pill in people with Acute Mountain Sickness, run by Peking University First Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Mountain Sickness
- What is being tested?
- Suxiao Jiuxin Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Sep 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 17Show fewer
- Subjects with left index finger oxygen saturation <95% at screening;
- 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;
- Subjects with hypersensitive C-reactive protein > upper limit of normal range at screening;
- Subjects with history of surgery or blood donation within 3 months prior to screening;
- Subjects with any medication or non-pharmacological intervention (including dietary supplements) to prevent or treat acute mountain sickness within 14 days prior to screening;
- Smoking ≥20 cigarettes per day within 3 months prior to screening;
- Contraindications to the use of Suxiao Jiuxin Pill, such as allergies;
- Women who are pregnant, breastfeeding, or have a positive pregnancy test (human chorionic gonadotropin test);
- 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;
- Participation in another interventional clinical study within 3 months prior to screening;
- Other conditions, in the opinion of the investigators, make participation in this study inappropriate.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Safety and Efficacy of Suxiao Jiuxin Pill for Prevention of Acute Mountain Sickness: a Randomized Controlled Trial
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.
Read the detailed description
Acute altitude illness refers to a group of clinical symptoms that occur when travelers are exposed to high altitude in a short period of time, due to the body's incomplete or dysregulated adaptation to hypoxic environment, which may occur at anytime from a few hours to 5 days after ascending, with severity ranging from mild discomfort to life-threatening conditions such as cerebral and pulmonary edema. AMS is the most common manifestation, characterized by headache, gastrointestinal symptoms, fatigue, weakness, dizziness, light-headedness, etc. Lake Louise Score (LLS) system has been widely used to evaluate AMS, and the version updated in 2018 kept nausea/vomiting, fatigue, lassitude and dizziness as the assessment symptom for AMS, and each symptom can be scored as 0-3 according to severity. AMS can be diagnosed when headache exist and total LLS is ≥ 3 points. Based on total scores, AMS can be defined as mild (3-5), moderate (6-9) and severe (10-12).
Suxiao Jiuxin Pill is a traditional Chinese medicine compound composed of Ligusticum Wallichii and Borneo Camphorwood, and its clinical safety has been confirmed. A total of 168 subjects will be enrolled in this randomized, controlled trial, and eligible subjects will be randomized into Suxiao Jiuxin Pill intervention group or Placebo group after informed consent is obtained. The study drug or placebo will be given orally for 4 days at sea level, arrival day and another 2 days at high altitude. The clinical assessments, including LLS system, sleep questionnaire scores, vital signs, blood oxygen saturation, blood routine test, blood biochemistry test, echocardiogram, Holter, ambulatory blood pressure monitoring, pulse wave velocity, and transcranial Doppler ultrasound parameters will be repeatedly performed at sea level and high altitude.
- Conditions
- Acute Mountain Sickness
- Being tested
- Suxiao Jiuxin Pill, Placebo
- Keywords
- Acute Mountain Sickness, Suxiao Jiuxin Pill, Traditional Chinese Medicine
- Medical subject headings
- Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suxiao Jiuxin PillDrug
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.
PlaceboDrug
Placebo is made of less than 10% of the amount of Suxiao Jiuxin Pill, with similar dosage, odor, and taste.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Suxiao Jiuxin Pill |
| 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The next morning of arrival day at high altitude
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Arrival day to Day 3 after high altitude exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study startAug 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Mountain SicknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tibet Autonomous Region Hospital of Traditional Tibetan Medicine
- Responsible party
- Sponsor
- Investigators
- Yong Huo, M.D., Principal investigator, Peking University First HospitalYan Zhang, M.D., Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531161
- Sponsor's protocol ID
- SXJX-AMS-02
- Acronym
- EVEREST
- Status last verified
- Aug 2024
- First submitted
- 28 Jul 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Suxiao Jiuxin Pill for Prevention of Acute Mountain Sickness: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06531161
- Acronym / sponsor ID
- EVEREST / SXJX-AMS-02
- Conditions
- Acute Mountain Sickness
- Keywords
- Acute Mountain Sickness, Suxiao Jiuxin Pill, Traditional Chinese Medicine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Tibet Autonomous Region Hospital of Traditional Tibetan Medicine
- Study start
- Aug 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Acute altitude illness refers to a group of clinical symptoms that occur when travelers are exposed to high altitude in a short period of time, due to the body's incomplete or dysregulated adaptation to hypoxic environment, which may occur at anytime from a few hours to 5 days after ascending, with severity ranging from mild discomfort to life-threatening conditions such as cerebral and pulmonary edema. AMS is the most common manifestation, characterized by headache, gastrointestinal symptoms, fatigue, weakness, dizziness, light-headedness, etc. Lake Louise Score (LLS) system has been widely used to evaluate AMS, and the version updated in 2018 kept nausea/vomiting, fatigue, lassitude and dizziness as the assessment symptom for AMS, and each symptom can be scored as 0-3 according to severity. AMS can be diagnosed when headache exist and total LLS is ≥ 3 points. Based on total scores, AMS can be defined as mild (3-5), moderate (6-9) and severe (10-12).
Suxiao Jiuxin Pill is a traditional Chinese medicine compound composed of Ligusticum Wallichii and Borneo Camphorwood, and its clinical safety has been confirmed. A total of 168 subjects will be enrolled in this randomized, controlled trial, and eligible subjects will be randomized into Suxiao Jiuxin Pill intervention group or Placebo group after informed consent is obtained. The study drug or placebo will be given orally for 4 days at sea level, arrival day and another 2 days at high altitude. The clinical assessments, including LLS system, sleep questionnaire scores, vital signs, blood oxygen saturation, blood routine test, blood biochemistry test, echocardiogram, Holter, ambulatory blood pressure monitoring, pulse wave velocity, and transcranial Doppler ultrasound parameters will be repeatedly performed at sea level and high altitude.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Suxiao Jiuxin Pill group | Experimental | Drug: Suxiao Jiuxin PillParticipants 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. |
| Placebo: Placebo group | Placebo comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suxiao Jiuxin PillSuxiao 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. | Drug | Experimental: Suxiao Jiuxin Pill group |
| PlaceboPlacebo is made of less than 10% of the amount of Suxiao Jiuxin Pill, with similar dosage, odor, and taste. | Drug | Placebo: Placebo group |
Primary outcome
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.
Time frame: The next morning of arrival day at high altitude
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.
9 secondary outcomes
Incidence rate of AMS assessed by LLS system after arrival at high altitude between Suxiao Jiuxin Pill and Placebo groups.
Time frame: Arrival day to Day 3 after high altitude exposure
Baseline-corrected LLS after high altitude exposure between Suxiao Jiuxin Pill and Placebo groups.
Time frame: 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.
Time frame: 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.
Time frame: The next morning of arrival day at high altitude
Mean AMS Clinical Functional Score after arrival between Suxiao Jiuxin Pill and Placebo groups.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Arrival day to Day 3 after high altitude exposure
Rate of oxygen treatment after arrival between Suxiao Jiuxin Pill and Placebo groups.
Time frame: Arrival day to Day 3 after high altitude exposure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong Huo, M.D. principal investigator
Peking University First Hospital
Yan Zhang, M.D. principal investigator
Peking University First Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Suxiao Jiuxin Pill in people with Acute Mountain Sickness, run by Peking University First Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kaiyin Li, M.D. (010-83575389, kaiyin0313@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: The next morning of arrival day at high altitude). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.