None listed
Conditions
Interventions
Experimental group:Xuesaitong soft capsule
Control Group:Placebo
Sponsors
Yunnan Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 55 years (including the boundary value), male or female; 2. Female volunteers weigh >=45.0 kg, male volunteers weigh >=50.0 kg, and the body mass index (BMI) is between 19.0 and 28.0 kg/m2 (including the boundary value) (BMI=weight kg/height m2); 3. Have a detailed understanding of the nature, significance, possible benefits, possible inconveniences and potential risks and discomforts of the trial before the trial, and voluntarily participate in this clinical trial, able to communicate well with investigators, and comply with the requirements of the entire study, and signed a written informed consent; 4. Volunteers from the trial period (women: within 14 days before the first dose, men: after the first dose) to 30 days after the end of the trial without fertility or sperm/egg donation plans and voluntarily take effective physical contraception.
Exclusion criteria
Exclusion criteria: 1. Those who are known to be allergic to the study drug (including the study drug excipients) or its analogs, or those with allergic constitution (such as those who are allergic to two or more drugs, food and pollen); 2. Those with a history of severe altitude sickness or a family history of severe altitude sickness; 3. Those who have a history of serious clinical diseases and have not been cured, or those who are currently suffering from diseases that may significantly affect the in vivo process or safety evaluation of the research drug; 4. Those who suffer from respiratory diseases such as obstructive pulmonary disease, asthma, pulmonary fibrosis, and tuberculosis and have not been cured; 5. Those who suffer from acute and chronic diseases of the nervous and mental systems (such as fatigue syndrome not caused by high altitude hypoxia, primary headache, sleep disturbance, severe anxiety, severe depression, etc.) and have not been cured (inquiry); 6. Those who suffer from acute and chronic diseases of the cardiovascular system, endocrine system, and urinary system (such as hypertension, congenital heart disease, cardiac insufficiency, diabetes, urinary system infection, etc.) and have not been cured; 7. Those who suffer from acute and chronic diseases of the digestive system (such as gastrointestinal bleeding, gastrointestinal ulcers, intestinal obstruction, diarrhea, constipation and other diseases that stimulate the gastrointestinal tract may cause danger) and have not been cured; 8. Those who have a history of vomiting caused by other reasons (such as vestibular disorder vomiting, neurological vomiting, central vomiting, etc.) and have not been cured; 9. Those who have undergone major surgery within 3 months (90 days) before the first administration, or those who have undergone surgery that may significantly affect the in vivo process or safety evaluation of the study drug; 10. Those who have used or are using any therapeutic drugs (including Chinese patent medicines and probiotic preparations, etc.) within 1 week (7 days) before the first administration (inquiry, inquiry); 11. Those who have used health products containing the active ingredients of the study drug within 2 weeks (14 days) before the first administration; 12. Those who have used clinical trial drugs within 3 months (90 days) before the first administration, or those who plan to participate in other clinical trials during this study; 13. Frequent alcohol consumption within 3 months (90 days) before the first administration; or a positive alcohol breath test; 14. Smoking (more than 10 cigarettes or equivalent amount of tobacco per day) within 3 months (90 days) before the first administration; 15. Within 1 week (7 days) before the first administration, continuous consumption of food that significantly affects the intestinal flora (such as yogurt or food containing probiotics); 16. Those with a history of substance abuse (inquiry) or a positive substance abuse screening test; 17. Those who were tested positive for hepatitis B surface antigen, hepatitis C virus antibody, Treponema pallidum antibody or human immunodeficiency virus antibody in the screening period; 18. Physical examination, vital signs, laboratory tests (blood routine, urine routine, electrolytes, liver function, renal function, fasting blood glucose, coagulation function and high-sensitivity C-reactive protein, etc.), twelve-lead electrocardiogram, cardiac Color Doppler ultrasound, pulmona
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute mountain sickness incidence; | — |
Secondary
| Measure | Time frame |
|---|---|
| Acute mountain sickness occurrence time;Acute mountain sickness clinical symptom scale score;Acute mountain sickness clinical symptom scale score - area under time curve;Acute mountain sickness score decline time;Acute mountain sickness score decline rate;Sleep monitoring;Oxygen saturation;breathing;blood pressure;heart rate;vascular endothelial function; | — |
Countries
China
Contacts
Public ContactHe Jianchang
Yunnan Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed