Skip to main content
OpenTrials
Completed

NCT Number: NCT03270787

Study of Compound Danshen Dripping Pills to Treat Acute Mountain Sickness

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

People's Hospital of Tibet Autonomous Region

Damxung, Tibet, 850000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

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

Compound Danshen Dripping Pills

Drug

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

Primary outcomes

  1. The incidence of acute mountain sickness rapid radical to an altitude of 3000m above the plateau region compared to placebo

    Time frame: 7days

Sponsors and collaborators

Lead sponsor

Tasly Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Sep 1, 2017
Registry last updated
Sep 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.