Study of Compound Danshen Dripping Pills to Treat Acute Mountain Sickness

NCT03270787 | Completed Phase 1 DMC

• 1 other identifier: TCM1421
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Mountain Sickness

Keywords

Acute Mountain sickness; Compound Danshen Dripping Pills

Outcome Measures

Primary Outcomes (1)

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

  7days

Study Arms (2)

Placebo Comparator

PLACEBO COMPARATOR

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

Drug: Placebo

Compound danshen dripping pills

EXPERIMENTAL

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

Drug: Compound danshen dripping pills

Interventions

Placebo DRUG

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

Placebo Comparator

Compound danshen dripping pills DRUG

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

Compound danshen dripping pills

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tasly Pharmaceuticals, Inc.: lead

Study Sites (1)

People's Hospital of Tibet Autonomous Region

Damxung, Tibet, 850000, China

Location

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Min Zhao, PhD

  Tasly Group, Co. Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2016
• First Posted: September 1, 2017
• Study Start: June 24, 2016
• Primary Completion: July 13, 2016
• Study Completion: July 13, 2017
• Last Updated: September 1, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)