Study of Compound Danshen Dripping Pills to Treat Acute Mountain Sickness

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

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

Study Overview

• Status: Completed
• Conditions: Acute Mountain Sickness
• Intervention / Treatment: Drug: Placebo; Drug: Compound danshen dripping pills

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 Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Tibet
    • Damxung, Tibet, China, 850000
      • People's Hospital of Tibet Autonomous Region

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo Comparator; Placebo Comparator: controlled group Placebo,10pills,tid,po	Drug: Placebo; Drug: Placebo Placebo,10pills,tid,treat 1 weeks.
EXPERIMENTAL: Compound danshen dripping pills; Compound danshen dripping pills Compound danshen dripping pills ,10pills,tid,po	Drug: Compound danshen dripping pills; Drug: Compound danshen dripping pills Compound danshen dripping pills,10pills,tid,treat 1 weeks.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tasly Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 24, 2016
• Primary Completion (ACTUAL): July 13, 2016
• Study Completion (ACTUAL): July 13, 2017

Study Registration Dates

• First Submitted: June 23, 2016
• First Submitted That Met QC Criteria: August 30, 2017
• First Posted (ACTUAL): September 1, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 1, 2017
• Last Update Submitted That Met QC Criteria: August 30, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Acute Mountain sickness; Compound Danshen Dripping Pills
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Altitude Sickness
• Other Study ID Numbers: TCM1421

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO