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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03270787

Enrollment

Registered

2017-09-01

Start date

2016-06-24

Completion date

2017-07-13

Last updated

2017-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Mountain Sickness

Keywords

Acute Mountain sickness, Compound Danshen Dripping Pills

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.

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

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

* 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

Design outcomes

Primary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026