CClinicalTrials.gg
Sign In
CompletedNCT03270787Updated Sep 1, 2017

Study of Compound Danshen Dripping Pills to Treat Acute Mountain Sickness

A Phase 1/2 interventional study of Placebo and Compound danshen dripping pills in Acute Mountain Sickness, sponsored by Tasly Pharmaceuticals, Inc.. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-01.

Sponsored by Tasly Pharmaceuticals, Inc. · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Acute Mountain Sickness

Browse trials for

Keywords

  • Acute Mountain sickness
  • Compound Danshen Dripping Pills
03

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
58 participants (actual)

Study arms

  • Placebo comparator
    Placebo Comparator

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

    Drug: Placebo

  • Experimental
    Compound danshen dripping pills

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

    Drug: Compound danshen dripping pills

Interventions

  • DrugPlacebo

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

  • DrugCompound danshen dripping pills

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

05

What researchers measure

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

06

Study locations

1 site
  • People's Hospital of Tibet Autonomous Region
    Damxung, Tibet 850000, China
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03270787
Lead sponsor
Tasly Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Sep 1, 2017
Start date
Jun 24, 2016
Primary completion
Jul 13, 2016
Completion
Jul 13, 2017
Last update
Sep 1, 2017

Study contacts

Min Zhao, PhD
study director · Tasly Group, Co. Ltd.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Altitude Sickness→

Other studies from this sponsor

Tasly Pharmaceuticals, Inc.

Start the discussion