Recruiting soon

EVERESTSuxiao Jiuxin Pill for Acute Mountain Sickness Prevention

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Suxiao Jiuxin Pill

+ Placebo

Drug
Who is being recruted

Altitude Sickness

+ Respiration Disorders

+ Respiratory Tract Diseases

From 18 to 55 Years
+22 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-ControlledPhase 2 & 3
Interventional
Study Start: August 2024
See protocol details

Summary

Principal SponsorPeking University First Hospital
Study ContactKaiyin Li, M.D.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2024

Actual date on which the first participant was enrolled.

This study focuses on finding a way to prevent Acute Mountain Sickness (AMS), which can happen when people quickly move to high altitudes. AMS causes symptoms like headaches, nausea, tiredness, and dizziness, and can range from mild to very serious, affecting the brain and lungs. The study tests a traditional Chinese medicine called Suxiao Jiuxin Pill, made from natural ingredients, to see if it can help prevent these symptoms. The goal is to help people adapt better to high altitudes and avoid discomfort or serious health issues. Participants in this trial will either take the Suxiao Jiuxin Pill or a placebo, which is a harmless pill with no active ingredients, for a total of four days. They will start taking the pills at sea level and continue for two more days after reaching high altitude. To measure the effectiveness of the treatment, researchers will use a scoring system called the Lake Louise Score, along with other health checks like sleep quality, vital signs, and blood tests. This study aims to provide a safe way to prevent AMS, making high-altitude travel safer and more comfortable.

Official TitleSafety and Efficacy of Suxiao Jiuxin Pill for Prevention of Acute Mountain Sickness: a Randomized Controlled Trial
NCT06531161
Principal SponsorPeking University First Hospital
Study ContactKaiyin Li, M.D.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

168 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Altitude SicknessRespiration DisordersRespiratory Tract Diseases

Criteria

5 inclusion criteria required to participate
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;
Show More Criteria
17 exclusion criteria prevent from participating
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;
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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.

Group II

Placebo
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
Recruiting soonNo study centers