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Study of Compound Danshen Dripping Pills to Treat Acute Mountain Sickness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03270787
Recruitment Status : Completed
First Posted : September 1, 2017
Last Update Posted : September 1, 2017
Sponsor:
Information provided by (Responsible Party):
Tasly Pharmaceuticals, Inc.

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

Condition or disease Intervention/treatment Phase
Acute Mountain Sickness Drug: Placebo Drug: Compound danshen dripping pills Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo-controlled Study of Compound Danshen Dripping Pills in Preventing and Treating Acute Mountain Sickness
Actual Study Start Date : June 24, 2016
Actual Primary Completion Date : July 13, 2016
Actual Study Completion Date : July 13, 2017


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.




Primary Outcome Measures :
  1. The incidence of acute mountain sickness rapid radical to an altitude of 3000m above the plateau region compared to placebo [ Time Frame: 7days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03270787


Locations
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China, Tibet
People's Hospital of Tibet Autonomous Region
Damxung, Tibet, China, 850000
Sponsors and Collaborators
Tasly Pharmaceuticals, Inc.
Investigators
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Study Director: Min Zhao, PhD Tasly Group, Co. Ltd.
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Responsible Party: Tasly Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03270787    
Other Study ID Numbers: TCM1421
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Tasly Pharmaceuticals, Inc.:
Acute Mountain sickness
Compound Danshen Dripping Pills
Additional relevant MeSH terms:
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Altitude Sickness
Respiration Disorders
Respiratory Tract Diseases