Study of Compound Danshen Dripping Pills to Treat Acute Mountain Sickness

Tasly Pharmaceuticals

Status and phase

Completed

Phase 2

Phase 1

Conditions

Acute Mountain Sickness

Treatments

Drug: Compound danshen dripping pills

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03270787

TCM1421

Details and patient eligibility

About

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

Full 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 Notoginseng) and borneol.Danshen is the main drug efficacy of stasis, nourishing the nerves.Pharmacological studies have shown that Danshen can improve the oxygen carrying capacity of blood, increase oxygen supply to vital organs, effectively reduce hypoxia-induced heart and other vital organs, brain and kidney damage. Danshen can activate the fibrinolytic system, reduce blood viscosity, clear the microcirculation, promote blood circulation, increasing the amount of tissue oxygen by inhibiting platelet aggregation.This study is being conducted to evaluate the efficacy and safety of compound danshen dripping pills in preventing and treating acute mountain sickness, when compared with placebo.

Enrollment

58 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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