Prevention and alleviation of altitude sickness (Acute Mountain Sickness AMS)
Conditions
Interventions
Experimental group: "Yuzhi Su" Tripterygium and Ginseng Oral Liquid (Highland Vitality)
Control Group One:Control Sample 1
Control Group Two:Control Sample 2
Sponsors
Shaanxi Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy volunteers: aged 18-60 years, of any gender; 2. Residing long-term in low-altitude areas (1000 meters or below); 3. In the six months prior to screening, have not been at altitudes above 2500 meters; 4. Able to read Chinese and accurately understand the study process, voluntarily participate in the study, and sign the informed consent form for the study; 5. Able to cooperate with and participate in follow-up visits of the study, promptly report any changes in their health status or food intake, adverse reaction symptoms, and able to comply with study requirements and schedule.
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant or breastfeeding; 2. Individuals who have had severe high-altitude reactions within the past 5 years, including high-altitude heart disease, high-altitude pulmonary edema, high-altitude cerebral edema, and high-altitude polycythemia; 3. LLSS score >=1 at the time of screening; 4. Blood oxygen saturation of the left-hand index finger =140 mmHg and/or diastolic blood pressure >=90 mmHg at screening); 6. Abnormal liver or kidney function at screening: ALT or AST >2 times the upper limit of normal, or creatinine > the upper limit of normal; 7. Use of any drug or non-drug intervention (including dietary supplements) to prevent or treat acute high-altitude reaction within 14 days before screening, including carbonic anhydrase inhibitors (dexamethasone, megestrol), non-steroidal anti-inflammatory drugs (acetazolamide, methazolamide), steroid medications (dexamethasone, megestrol), NSAIDs (ibuprofen, aspirin), and traditional Chinese medicines (Rhodiola, Codonopsis), etc.; 8. Individuals with contraindications or allergies to the drugs used; 9. Participation in other interventional human studies within 3 months prior to screening; 10. Subjects with other illnesses or conditions deemed by the investigator as unsuitable for inclusion in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lake Louise Score (LLS);Incidence and Severity of Acute Mountain Sickness (AMS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Physiological Indicators: Blood Pressure (SBP, DBP), Resting Heart Rate (RHR), Respiratory Rate (R), Oxygen Saturation (SpO?), Hemoglobin Level (Hb);Exercise Tolerance Test (ETT);Stress Response Indicators: Aldosterone (ALD), Cortisol, High-Sensitivity C-Reactive Protein (hs-CRP);Fatigue Scale-14 (FS-14) Score;Self-Rating Anxiety Scale (SAS) Score;Self-Rating Depression Scale (SDS) Score;Constitution Assessment Questionnaire (CAQ); | — |
Countries
China
Contacts
Public ContactZhang Xuanguo
Shaanxi Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed