Exploratory clinical study of Xuesaitong Soft Capsule in preventing acute mountain sickness in healthy adult volunteers

Phase 1

• Conditions: healthy volunteers

• Registration Number: ITMCTR2100005409
• Lead Sponsor: Yunnan Provincial Hospital of Traditional Chinese Medicine Research Center of Clinical Pharmacology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1) Age 18-55 years old (including boundary value), male and female;
2) Female volunteers weigh = 45.0 kg, male volunteers weigh = 50.0 kg, and body mass index (BMI) is between 19.0 and 28.0 kg/m2 (including boundary value) (BMI = weight kg/ height m2);
3) Before the trial, the nature, significance, possible benefits, possible inconvenience and potential risks and discomfort of the trial have been understood in detail, and they voluntarily participate in the clinical trial, can communicate well with the researchers, comply with the requirements of the whole study, and have signed a written informed consent;
4) Volunteers have no fertility or sperm / egg donation plan from the test period (female: within 14 days before the first administration, male: after the first administration) to 30 days after the end of the test, and voluntarily take effective physical contraceptives.

Exclusion Criteria

1) Those who are known to be allergic to the study drug (including the excipients of the study drug) or its analogues, or those with allergic constitution (such as those allergic to two or more drugs, food and pollen) ;
2) Those with history of severe acute mountain sickness or family history of severe acute mountain sickness ;
3) Those who have a history of clinically serious diseases and are not cured, or those who are suffering from diseases that may significantly affect the in vivo process or safety evaluation of the study drug ;
4) Those who suffer from respiratory diseases such as obstructive pulmonary disease, asthma, pulmonary fibrosis and tuberculosis and are not cured;
5) Suffering from acute and chronic diseases of nervous and mental system (such as fatigue syndrome not caused by altitude hypoxia, primary headache, sleep disorder, severe anxiety, severe depression, etc.) and not cured;
6) suffering from acute and chronic diseases such as cardiovascular system, endocrine system, urinary system,(such as hypertension, congenital heart disease, heart failure, diabetes, urinary tract infection, etc.);
7) Suffering from acute and chronic diseases of the digestive system (such as gastrointestinal bleeding, gastrointestinal ulcer, intestinal obstruction, diarrhea, constipation and other diseases that may cause danger by stimulating the gastrointestinal tract) and not cured ;
8) Those who have a history of vomiting caused by other reasons (such as vestibular obstacle vomiting, neurofunctional vomiting, central vomiting, etc.) and are not cured ;
9) Major surgery received within 3 months (90 days) before the first administration, or 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 drugs and probiotic preparations) within 1 week (7 days) before the first administration ;
11) Those who have used health products containing 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) regular drinking ; or alcohol breath test positive ;
14) Smoking (more than 10 cigarettes or the same amount of tobacco per day) within 3 months (90 days) before the first administration;
15) Continuous consumption of foods that significantly affect intestinal flora (such as yogurt or foods containing probiotics) within 1 week (7 days) before the first administration ;
16) Persons with a history of substance abuse or positive substance abuse screening ;
17) Those who are positive for HBsAg, HCV antibody, treponema pallidum antibody or human immunodeficiency virus antibody during screening ;
18) The results of physical examination, vital signs, laboratory examination (blood routine, urine routine, electrolyte, liver function, renal function, fasting blood glucose, coagulation function and high-sensitivity C-reactive protein, etc.), 12 lead ECG, cardiac color Doppler ultrasound, pulmonary function, X-ray chest film, etc. in the screening period are judged to be abnormal and clinically significant by the clinical doctor ;
19) Women who were pregnant or lactating at the time of screening ; Women with positive pregnancy test at screening;
20) When screening, any AMS clinical symptom scale score re

Study & Design

• Study Type: Interventional study
• Study Design: Not specified