Study of Compound Danshen Dripping Pills to Treat Acute Mountain Sickness

NCT ID: NCT03270787

Last Updated: 2017-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-24
• Study Completion Date: 2017-07-13

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.

Conditions

Acute Mountain Sickness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo Comparator

Placebo Comparator: controlled group Placebo,10pills,tid,po

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Drug: Placebo Placebo,10pills,tid,treat 1 weeks.

Compound danshen dripping pills

Compound danshen dripping pills Compound danshen dripping pills ,10pills,tid,po

Group Type: EXPERIMENTAL

Compound danshen dripping pills

Intervention Type: DRUG

Drug: Compound danshen dripping pills Compound danshen dripping pills,10pills,tid,treat 1 weeks.

Interventions

Placebo

Drug: Placebo Placebo,10pills,tid,treat 1 weeks.

Intervention Type: DRUG

Compound danshen dripping pills

Drug: Compound danshen dripping pills Compound danshen dripping pills,10pills,tid,treat 1 weeks.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tasly Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Min Zhao, PhD

Role: STUDY_DIRECTOR

Tasly Group, Co. Ltd.

Locations

People's Hospital of Tibet Autonomous Region

Damxung, Tibet, China

Countries

China

Other Identifiers

TCM1421

Identifier Type: -

Identifier Source: org_study_id