Acute Mountain Sickness
Conditions
Interventions
GYP Group:Take GYP Granules
Placebo Group:Take Placebo Granules
Sponsors
Hospital of Chengdu University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Healthy individuals aged 18–60 years (both sexes eligible). 2.Born and long-term residents of low-altitude areas (4 days during the trial. 4.TCM constitution assessment confirming Qi-deficient constitution. 5.Voluntary participation with signed informed consent form.
Exclusion criteria
Exclusion criteria: 1.Pre-existing chronic headache dizziness or severe cardiovascular/cerebrovascular respiratory digestive or hematological diseases (including but not limited to sickle cell anemia severe asthma/COPD severe anemia or significant coronary artery disease) before high-altitude exposure. 2.Pregnant or lactating women. 3.Patients with epilepsy or schizophrenia. 4.Individuals with allergic constitution multiple drug allergies or history of allergy to trial drug components/structurally similar medications. 5.During screening: Lake Louise Self-Assessment Score (LLSS) =2 at any time SpO2 <95% or clinically significant abnormal liver/kidney function. 6.Surgery within 3 months. 7.Regular smokers. 8.High-altitude exposure (=2500m) within 1 month. 9.Use of antibiotics diuretics steroids acetazolamide or NSAIDs within 1 month. 10.Use of oxygen-enhancing drugs within 6 months. 11.Participation in other clinical trials within 1 month. 12.Tibetan ethnicity. 13.BMI =30 kg/m².
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of acute mountain sickness; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of severe acute mountain sickness;Arterial Blood Gas Analysis;TCM (Traditional Chinese Medicine) Symptom Score;6-Minute Walk Test (6MWT);Short Form-36 Health Survey (SF-36); | — |
Countries
China
Contacts
Public ContactWang Zhenxing
Hospital of Chengdu University of Traditional Chinese Medicine
Outcome results
None listed