Study of Compound Danshen Dripping Pills to Treat Acute Mountain Sickness

Acute Mountain Sickness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03270787
• Other study ID #: TCM1421
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 23, 2016
• Last updated: August 30, 2017
• Start date: June 24, 2016
• Est. completion date: July 13, 2017

Study information

• Verified date: August 2017
• Source: Tasly Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: July 13, 2017
• Est. primary completion date: July 13, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Mountain Sickness
• Altitude Sickness

Intervention

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

Locations

Country	Name	City	State
China	People's Hospital of Tibet Autonomous Region	Damxung	Tibet

Sponsors (1)

Lead Sponsor	Collaborator
Tasly Pharmaceuticals, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of acute mountain sickness rapid radical to an altitude of 3000m above the plateau region compared to placebo		7days