Study of Compound Danshen Dripping Pills to Treat Acute Mountain Sickness

• Status: Completed
• Trial end date: 2017-07-13
• Target enrollment: 0
• Participant gender: All

Summary

This study is to evaluate the efficacy and safety of compound danshen dripping pills in preventing and treating acute mountain sickness.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tasly Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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