Study of Compound Danshen Dripping Pills to Treat Acute Mountain Sickness

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Acute mountain sickness
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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

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.

Study Phase

Phase 1/Phase 2

Study Type

Interventional

Primary Outcome

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

Condition

Acute Mountain Sickness

Intervention

Placebo

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

58

Start Date

June 24, 2016

Completion Date

July 13, 2017

Primary Completion Date

July 13, 2016

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

Gender

All

Ages

18 Years - 45 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Min Zhao, PhD, ,

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT03270787

Organization ID

TCM1421

Responsible Party

Sponsor

Study Sponsor

Tasly Pharmaceuticals, Inc.

Study Sponsor

Min Zhao, PhD, Study Director, Tasly Group, Co. Ltd.

Verification Date

August 2017