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Study of Compound Danshen Dripping Pills to Treat Acute Mountain Sickness

Primary Purpose

Acute Mountain Sickness

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Placebo
Compound danshen dripping pills
Sponsored by
Tasly Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Mountain Sickness focused on measuring Acute Mountain sickness, Compound Danshen Dripping Pills

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • People's Hospital of Tibet Autonomous Region

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Comparator

Compound danshen dripping pills

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 23, 2016
Last Updated
August 30, 2017
Sponsor
Tasly Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03270787
Brief Title
Study of Compound Danshen Dripping Pills to Treat Acute Mountain Sickness
Official Title
A Randomized, Double Blind, Placebo-controlled Study of Compound Danshen Dripping Pills in Preventing and Treating Acute Mountain Sickness
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
June 24, 2016 (Actual)
Primary Completion Date
July 13, 2016 (Actual)
Study Completion Date
July 13, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tasly Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Mountain Sickness
Keywords
Acute Mountain sickness, Compound Danshen Dripping Pills

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
Placebo Comparator: controlled group Placebo,10pills,tid,po
Arm Title
Compound danshen dripping pills
Arm Type
Experimental
Arm Description
Compound danshen dripping pills Compound danshen dripping pills ,10pills,tid,po
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Drug: Placebo Placebo,10pills,tid,treat 1 weeks.
Intervention Type
Drug
Intervention Name(s)
Compound danshen dripping pills
Intervention Description
Drug: Compound danshen dripping pills Compound danshen dripping pills,10pills,tid,treat 1 weeks.
Primary Outcome Measure Information:
Title
The incidence of acute mountain sickness rapid radical to an altitude of 3000m above the plateau region compared to placebo
Time Frame
7days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Zhao, PhD
Organizational Affiliation
Tasly Group, Co. Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
People's Hospital of Tibet Autonomous Region
City
Damxung
State/Province
Tibet
ZIP/Postal Code
850000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of Compound Danshen Dripping Pills to Treat Acute Mountain Sickness

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