Acute Mountain Sickness (AMS)Phase 2NCT01682551
Evaluation of the Prevention and Treatment Effects of Chinese Medicine on High Altitude Illness
A Phase 2 study testing Chinese Medicine and Acetalozamide in people with Acute Mountain Sickness (AMS), run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
This trial is aimed to evaluate the effects of "Wu Zhu Yu Tang" on the prevention of Acute Mountain Sickness(AMS). Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Mountain Sickness (AMS)
- What is being tested?
- Chinese Medicine and Acetalozamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2012to Sep 2012
- Phase
- Phase 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults
Who cannot join
- Chronic disease: cardiovascular disease, psychological disease, anemia, migraine.
- long-term use of the following materials: Chinese herbs, steroid, antibiotics.
- altitude acclimation: have been to mountain over 2000m in the past 1 month.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
School of Chinese Medicine, China Medical University
Taichung, Taiwan, 404
About this study
This trial is aimed to evaluate the effects of "Wu Zhu Yu Tang" on the prevention of Acute Mountain Sickness(AMS).
Read the detailed description
This study is a randomized, double blind, placebo-controlled clinical trial. It aims to demonstrate that (1) Chinese medicine prescription "Wu Zhu Yu Tang" can prevent Acute Mountain Sickness(AMS) (2) "Wu Zhu Yu Tang" can prevent AMS especially for Yang-Xu body constitution.
We will randomize 240 unacclimatized healthy adults. They will be randomized after stratification of the Yang-Xu score and the AMS history to receive Chinese medicine during one ascent and placebo during the other ascent. We will take them in Hehuan mountain for two days hike (24 hours) and an overnight over 3,000m. One month before the study, the subjects will fill the "Body Constitution Questionnaire BCQ" in order to evaluate their body constitution. Before, during and after the two days hike we will measure their blood pressure, heart rate and arterial oxygen saturation. The incidence of AMS will be measured by the Lake Louise Self Report (Lake Louise Score ≥4 with headache), we will also report the Lake Louise Clinical Assessment score and Lake Louise Functional Score.
- Conditions
- Acute Mountain Sickness (AMS)
- Being tested
- Chinese Medicine, Acetalozamide
- Keywords
- High altitude illness, Chinese medicine body constitution, Chinese Medicine, High altitude medicine, Mountain trekking
- Medical subject headings
- Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese MedicineDrug
Also called "Wu Zhu Yu Tang"
The participators in this arm will take 2g (powder in capsule) of "Wu Zhu Yu Tang" or placebo orally three times in the first day and one time in the second day.
AcetalozamideDrug
If the participators have the history of AMS, he/she will be randomized to take "Wu Zhu Yu Tang" plus "placebo of Acetalozamide" or "Acetalozamide" plus "placebo of Wu Zhu Yu Tang".
| Study group | Role | What they receive |
|---|---|---|
| Chinese Medicine | Experimental | The participators in this arm will take 2g (powder in capsule) of "Wu Zhu Yu Tang" or placebo orally three times in the first day and one time in the second day. Receives: Drug: Chinese Medicine |
| Acetazolamide | Placebo comparator | If the participators have the history of AMS, he/she will be randomized to take "Wu Zhu Yu Tang" plus "placebo of Acetalozamide" or "Acetalozamide" plus "placebo of Wu Zhu Yu Tang". Receives: Drug: Chinese Medicine; Drug: Acetalozamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of AMS will be measured by the Lake Louise Self Report (Lake Louise Score ≥4 with headache)
The investigators will take the participators in Hehuan mountain for two days hike (24 hours) and an overnight over 3,000m. The Lake Louise score will measure before and after hiking.
Measured: The Lake Louise Score will be measured in the noon of the second day after hiking to determine the onset of AMS.
Secondary outcomes (3)
Blood pressure
The investigators will take the participators in Hehuan mountain for two days hike (24 hours) and an overnight over 3,000m. The change of blood pressure will be measured before and after hiking.
Measured: Blood pressure will be measured before and after the hiking.
Heart rate
The investigators will take the participators in Hehuan mountain for two days hike (24 hours) and an overnight over 3,000m. The change of heart rate will be measured before and after hiking.
Measured: Heart rate will be measured before and after the hiking.
Arterial oxygen saturation
Description:
The investigators will take the participators in Hehuan mountain for two days hike (24 hours) and an overnight over 3,000m. The change of arterial oxygen saturation will be measured before and after hiking.
Measured: Arterial oxygen saturation will be measured before and after the hiking.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Mountain Sickness (AMS)Studies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- China Medical University, China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01682551
- Sponsor's protocol ID
- NRICM-10101
- Status last verified
- Sep 2012
- First submitted
- 5 Sep 2012
- Last updated
- 17 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prevention and Treatment Effects of Chinese Medicine on High Altitude Illness
- ClinicalTrials.gov ID
- NCT01682551
- Acronym / sponsor ID
- NRICM-10101
- Conditions
- Acute Mountain Sickness (AMS)
- Keywords
- High altitude illness, Chinese medicine body constitution, Chinese Medicine, High altitude medicine, Mountain trekking
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- China Medical University, China
- Study start
- Sep 2012
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 11 Sep 2012 (estimated)
- 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 trial is aimed to evaluate the effects of "Wu Zhu Yu Tang" on the prevention of Acute Mountain Sickness(AMS).
Detailed description
This study is a randomized, double blind, placebo-controlled clinical trial. It aims to demonstrate that (1) Chinese medicine prescription "Wu Zhu Yu Tang" can prevent Acute Mountain Sickness(AMS) (2) "Wu Zhu Yu Tang" can prevent AMS especially for Yang-Xu body constitution.
We will randomize 240 unacclimatized healthy adults. They will be randomized after stratification of the Yang-Xu score and the AMS history to receive Chinese medicine during one ascent and placebo during the other ascent. We will take them in Hehuan mountain for two days hike (24 hours) and an overnight over 3,000m. One month before the study, the subjects will fill the "Body Constitution Questionnaire BCQ" in order to evaluate their body constitution. Before, during and after the two days hike we will measure their blood pressure, heart rate and arterial oxygen saturation. The incidence of AMS will be measured by the Lake Louise Self Report (Lake Louise Score ≥4 with headache), we will also report the Lake Louise Clinical Assessment score and Lake Louise Functional Score.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chinese Medicine | Experimental | Drug: Chinese MedicineThe participators in this arm will take 2g (powder in capsule) of "Wu Zhu Yu Tang" or placebo orally three times in the first day and one time in the second day. |
| Acetazolamide | Placebo comparator | Drug: Chinese Medicine, Drug: AcetalozamideIf the participators have the history of AMS, he/she will be randomized to take "Wu Zhu Yu Tang" plus "placebo of Acetalozamide" or "Acetalozamide" plus "placebo of Wu Zhu Yu Tang". |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adults
Key exclusion criteria (4 listed)
- Chronic disease: cardiovascular disease, psychological disease, anemia, migraine.
- long-term use of the following materials: Chinese herbs, steroid, antibiotics.
- altitude acclimation: have been to mountain over 2000m in the past 1 month.
- Pregnancy.
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 |
|---|---|---|
| Chinese MedicineAlso: "Wu Zhu Yu Tang"The participators in this arm will take 2g (powder in capsule) of "Wu Zhu Yu Tang" or placebo orally three times in the first day and one time in the second day. | Drug | Acetazolamide, Chinese Medicine |
| AcetalozamideIf the participators have the history of AMS, he/she will be randomized to take "Wu Zhu Yu Tang" plus "placebo of Acetalozamide" or "Acetalozamide" plus "placebo of Wu Zhu Yu Tang". | Drug | Acetazolamide |
Primary outcome
The incidence of AMS will be measured by the Lake Louise Self Report (Lake Louise Score ≥4 with headache)
Time frame: The Lake Louise Score will be measured in the noon of the second day after hiking to determine the onset of AMS.
The investigators will take the participators in Hehuan mountain for two days hike (24 hours) and an overnight over 3,000m. The Lake Louise score will measure before and after hiking.
3 secondary outcomes
Blood pressure
Time frame: Blood pressure will be measured before and after the hiking.
Heart rate
Time frame: Heart rate will be measured before and after the hiking.
Arterial oxygen saturation
Time frame: Arterial oxygen saturation will be measured before and after the hiking.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2012.
Related trials for Acute Mountain Sickness (AMS)
Active, not recruitingEarly Phase 1
The Role of Acetazolamide in Mitigating Inflammation and Innate Immune Activation at High Altitude
Hypoxemia, Acute Mountain Sickness (AMS)
Not yet recruiting
Efficacy of Positive Expiratory Pressure on Acute Mountain Sickness
Acute Mountain Sickness (AMS)
RecruitingPhase 4
HighCycle Study: Acetazolamide, High Altitude and Plasma Volume
High Altitude Effects, High Altitude Hypoxia
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chinese Medicine and Acetalozamide in people with Acute Mountain Sickness (AMS), run by China Medical University Hospital at 1 site in Taiwan.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 17 Sep 2012. 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 Taiwan. 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 phase mean?
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?
Results are not available in the source record.
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 AMS will be measured by the Lake Louise Self Report (Lake Louise Score ≥4 with headache) (time frame: The Lake Louise Score will be measured in the noon of the second day after hiking to determine the onset of AMS.). 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 17 Sep 2012.