Study of Compound Danshen Dripping Pills to Treat Acute Mountain Sickness

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

Detailed Description
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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.

Official Title
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A Randomized, Double Blind, Placebo-controlled Study of Compound Danshen Dripping Pills in Preventing and Treating Acute Mountain Sickness

Conditions
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Acute Mountain Sickness

Intervention / Treatment
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* Drug: Placebo
* Drug: Compound danshen dripping pills


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Comparator<br>Placebo Comparator: controlled group Placebo,10pills,tid,po | Drug: Placebo<br>* Drug: Placebo Placebo,10pills,tid,treat 1 weeks.<br>|
| Experimental: Compound danshen dripping pills<br>Compound danshen dripping pills Compound danshen dripping pills ,10pills,tid,po | Drug: Compound danshen dripping pills<br>* Drug: Compound danshen dripping pills Compound danshen dripping pills,10pills,tid,treat 1 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of acute mountain sickness rapid radical to an altitude of 3000m above the plateau region compared to placebo |  | 7days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Mountain sickness, Compound Danshen Dripping Pills