Clinical trial NCT03270787: Study of Compound Danshen Dripping Pills to Treat Acute Mountain Sickness
Official title: A Randomized, Double Blind, Placebo-controlled Study of Compound Danshen Dripping Pills in Preventing and Treating Acute Mountain Sickness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acute Mountain Sickness
Keywords: Acute Mountain sickness
Compound Danshen Dripping Pills
Lead sponsor: Tasly Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2017-09-01
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility 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

Primary outcomes:
measure: The incidence of acute mountain sickness rapid radical to an altitude of 3000m above the plateau region compared to placebo
timeFrame: 7days
Secondary outcomes:
Other outcomes:
Locations:
city: Damxung
country: China
facility: People's Hospital of Tibet Autonomous Region
state: Tibet
Study officials:
affiliation: Tasly Group, Co. Ltd.
name: Min Zhao, PhD
role: STUDY_DIRECTOR
References: