Study of Compound Danshen Dripping Pills to Treat Acute Mountain Sickness

Phase 1

Completed

• Conditions: Acute Mountain Sickness
• Interventions: Drug: Placebo; Drug: Compound danshen dripping pills

• Registration Number: NCT03270787
• Lead Sponsor: Tasly Pharmaceuticals, Inc.

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.

Study Timeline

• Study First Submitted: 2016-06-23
• Study Start: 2016-06-24
• Primary Completion: 2016-07-13
• Study Completion: 2017-07-13
• Status Verified: 2017-08
• Study First Submitted QC: 2017-08-30
• Last Update Submitted: 2017-08-30
• Study First Posted: 2017-09-01
• Last Update Posted: 2017-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Comparator	Placebo	Placebo Comparator: controlled group Placebo,10pills,tid,po
Compound danshen dripping pills	Compound danshen dripping pills	Compound danshen dripping pills Compound danshen dripping pills ,10pills,tid,po

Primary Outcome Measures

Name	Time	Method
The incidence of acute mountain sickness rapid radical to an altitude of 3000m above the plateau region compared to placebo	7days

Trial Locations

Locations (1)

People's Hospital of Tibet Autonomous Region; 🇨🇳 Damxung, Tibet, China