Acute Mountain Sickness
Conditions
Interventions
Control Group A:Take Shenqi Citian Granule Simulant + Hongyi Capsule Simulant.
Experimental Group:Take Shenqi Citian Granules + Hongyi Capsule placebo.
Control Group B:Take Hongyi Capsules + Shenqi Citian Granules placebo.
Sponsors
China Academy of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 5.1 Inclusion Criteria: 1) Agree to participate in this clinical trial and sign the informed consent form; 2) Age between 18 and 45 years, gender; 3) Healthy volunteers entering the high-altitude region from plain areas for the first time (or those without high-altitude exposure history within the past year); 4) Volunteers deemed suitable for participation in this trial by the investigator (no exclusion criteria apply, generally in good health).
Exclusion criteria
Exclusion criteria: 5.2 Exclusion Criteria: 1) Individuals who are unable to sign the informed consent or are deemed unsuitable for participation by the investigator. 2) Participants with allergies to any components of the Shengqi Cishen Granules. 3) Individuals with fever, acute illnesses, severe chronic diseases, or those in the acute exacerbation phase of a chronic disease. 4) Pregnant women, breastfeeding women, and male smokers. 5) Participants with a history of seizures, epilepsy, encephalopathy, or mental illness, or a family history thereof; individuals with uncontrolled epilepsy or other progressive neurological diseases; and those with a history of Guillain-Barré syndrome. 6) Participants diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, or other autoimmune diseases. 7) Participants with severe underlying conditions involving the heart, liver, kidneys, digestive system, or hematopoietic system, including those with aspartate aminotransferase (AST), alanine aminotransferase (ALT), or blood urea nitrogen (BUN) levels exceeding 1.5 times the upper limit of normal, or creatinine (Cr) levels exceeding the upper limit of normal. This also includes individuals with known or suspected severe respiratory diseases, severe cardiovascular diseases, hepatic or renal diseases, or malignant tumors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute Mild High-Altitude Illness Symptom Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Motor Function;Blood Oxygen Saturation;Blood Gas Analysis;Echocardiogram;immune inflammatory markers;Traditional Chinese Medicine Constitution Questionnaire;Cognitive Function Test; | — |
Countries
China
Contacts
Public ContactMa Yan, Xiong Yibai, Chen Jian
China Academy of Traditional Chinese Medicine, Institute of Basic Theory of Traditional Chinese Medicine, Institute of Clinical Basic Medicine of Traditional Chinese Medicine, Department of High Altitude Military Medicine, Army Military Medical Universit
Outcome results
None listed