Acute Mountain SicknessPhase 1/2NCT03270787
Study of Compound Danshen Dripping Pills to Treat Acute Mountain Sickness
A Phase 1/2 study testing Compound danshen dripping pills in people with Acute Mountain Sickness, run by Tasly Pharmaceuticals, Inc. at 1 site in China.
Trial summary
This study is to evaluate the efficacy and safety of compound danshen dripping pills in preventing and treating acute mountain sickness. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Mountain Sickness
- What is being tested?
- Compound danshen dripping pills
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 24 Jun 2016to 13 Jul 2017
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind, Placebo-controlled Study of Compound Danshen Dripping Pills in Preventing and Treating Acute Mountain Sickness
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.
- Conditions
- Acute Mountain Sickness
- Being tested
- Placebo, Compound danshen dripping pills
- Keywords
- Acute Mountain sickness, Compound Danshen Dripping Pills
- Medical subject headings
- Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Drug: Placebo Placebo,10pills,tid,treat 1 weeks.
Compound danshen dripping pillsDrug
Drug: Compound danshen dripping pills Compound danshen dripping pills,10pills,tid,treat 1 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Comparator | Placebo comparator | Placebo Comparator: controlled group Placebo,10pills,tid,po Receives: Drug: Placebo |
| Compound danshen dripping pills | Experimental | Compound danshen dripping pills Compound danshen dripping pills ,10pills,tid,po Receives: Drug: Compound danshen dripping pills |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of acute mountain sickness rapid radical to an altitude of 3000m above the plateau region compared to placebo
Measured: 7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start24 Jun 2016
- Primary completion13 Jul 2016
- Study completion13 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Mountain SicknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tasly Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min Zhao, PhD, Study director, Tasly Group, Co. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03270787
- Sponsor's protocol ID
- TCM1421
- Status last verified
- Aug 2017
- First submitted
- 23 Jun 2016
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-controlled Study of Compound Danshen Dripping Pills in Preventing and Treating Acute Mountain Sickness
- ClinicalTrials.gov ID
- NCT03270787
- Acronym / sponsor ID
- TCM1421
- Conditions
- Acute Mountain Sickness
- Keywords
- Acute Mountain sickness, Compound Danshen Dripping Pills
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Tasly Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Jun 2016 (actual)
- Primary completion
- 13 Jul 2016 (actual)
- Study completion
- 13 Jul 2017 (actual)
- First posted
- 1 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Comparator | Placebo comparator | Drug: PlaceboPlacebo Comparator: controlled group Placebo,10pills,tid,po |
| Compound danshen dripping pills | Experimental | Drug: Compound danshen dripping pillsCompound danshen dripping pills Compound danshen dripping pills ,10pills,tid,po |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboDrug: Placebo Placebo,10pills,tid,treat 1 weeks. | Drug | Placebo Comparator |
| Compound danshen dripping pillsDrug: Compound danshen dripping pills Compound danshen dripping pills,10pills,tid,treat 1 weeks. | Drug | Compound danshen dripping pills |
Primary outcome
The incidence of acute mountain sickness rapid radical to an altitude of 3000m above the plateau region compared to placebo
Time frame: 7days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Zhao, PhD study director
Tasly Group, Co. Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Compound danshen dripping pills in people with Acute Mountain Sickness, run by Tasly Pharmaceuticals, Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of acute mountain sickness rapid radical to an altitude of 3000m above the plateau region compared to placebo (time frame: 7days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2017.