Status:
COMPLETED
Study of Compound Danshen Dripping Pills to Treat Acute Mountain Sickness
Lead Sponsor:
Tasly Pharmaceuticals, Inc.
Conditions:
Acute Mountain Sickness
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
PHASE2
Brief Summary
This study is to evaluate the efficacy and safety of compound danshen dripping pills in preventing and treating acute mountain sickness.
Detailed Description
Compound danshen dripping pills is mainly used for the treatment and prevention of coronary heart disease and high-risk groups ,consists of Danshen (Radix Salviae Miltiorrhizae), Sanqi (Radix Notogins...
Eligibility Criteria
Inclusion
- aged 18-45 years，Male or female, plain natives
- first stationed at high altitude above 3,000 meters
- Upon physical examination before enrollment in good health
- BMI 19 to 24; (weight kg / height Sqm )
- voluntary signs the informed consent
Exclusion
- menstruation, pregnancy and breast-feeding women
- smoking, alcohol and drug abusers
- Clear history of drug allergy or allergic persons
- application of various drugs (including traditional Chinese medicine) two weeks ago
- Combined with severe liver and kidney dysfunction (cardiac function Grade ≥3, liver function Grade \> 2 times of the upper limit of normal, Cr\> upper limit of normal);
- Subject with blood donation experiences or blood test experiences within three months before be selected.
- C- reactive protein test results exceed the upper limit of normal.
- clinically significant gastrointestinal disease, mental illness and diabetes, hyperthyroidism and other metabolic diseases;
- Past suffering from cardiovascular and cerebrovascular disease
- fatigue syndrome that is not by high altitude-induced
- primary headache
- Vomiting due to other causes, such as digestive disorders as a result of the vomiting reflex, vomiting vestibular disorders, neurotic vomiting;
- Allergies
- Who participated in clinical trials of other drugs within a month
- blood circulation, increase immunity and antioxidant drug users
Key Trial Info
Start Date :
June 24 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 13 2017
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT03270787
Start Date
June 24 2016
End Date
July 13 2017
Last Update
September 1 2017
Active Locations (1)
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1
People's Hospital of Tibet Autonomous Region
Damxung, Tibet, China, 850000