Can Rhodiola Crenulata Intake Improve Oxygen Saturation and Decrease the Incidence of Acute Mountain Sickness
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Purpose
Traditional folk medicine in the Arctic and Himalayan areas used Rhodiola species to enhance physical endurance, prevent aging, resist acute mountain sickness (AMS), and to treat fatigue, depression, anemia, impotence and respiratory infections. Rhodiola crenulata are widely used to prevent AMS in Himalayan areas and Lhasa in Tibet but none was examined by human study. The investigators conducted a randomized, double blind, placebo controlled, crossover study to investigate the efficacy of Rhodiola crenulata in preventing AMS.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Mountain Sickness Environmental Illness |
Drug: Rhodiola crenulata Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Can Rhodiola Crenulata Intake Improve Oxygen Saturation and Decrease the Incidence of Acute Mountain Sickness. |
- Incidence measured by Lake Louise acute mountain sickness score (LLS) ≥ 3 with headache and one other symptom. [ Time Frame: within 18 hours after ascent to altitude 3100m ] [ Designated as safety issue: Yes ]The LLS rates 5 symptoms (headache, gastrointestinal symptoms such as nausea and vomiting, fatigue and/or weakness, dizziness and/or light-headedness, and difficulty sleeping), with each item graded on a scale from 0 to 3. A score of 3 points or greater constitutes AMS.
- blood oxygen content [ Time Frame: on arrival of altitude 3100m ] [ Designated as safety issue: Yes ]Blood oxygen content was measured by pulse oximetry (NPB 40, Nellcor, Pleasanton, CA, USA) within 1-2 hours after ascent to altitude 3100m.
- severe AMS [ Time Frame: within 18 hours after ascent to altitude 3100m ] [ Designated as safety issue: Yes ]Incidence measured by Lake Louise acute mountain sickness score (LLS) ≥ 5 with headache and one other symptom.
- severity of headache, incidence of headache and severe headache [ Time Frame: Within 18 hours after ascent to altitude 3100m ] [ Designated as safety issue: Yes ]severe headache is determined by cut off between scores of 1 and 2 on the Lake Louise survey (ascending scale of 0-3 for severity)
| Enrollment: | 125 |
| Study Start Date: | October 2010 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Rhodiola crenulata-placebo sequence
Rhodiola crenulata for the first treatment period and placebo for the second treatment period, with a washout period of 4 months. Overall study population were 120 subjects, who were randomised and allocated into 2 sequences.
|
Drug: Rhodiola crenulata
Rhodiola crenulata:capsules, 800 mg daily for 7 days before ascent and 2 days during mountaineering
Other Names:
Drug: placebo
Placebo:capsules, 800 mg daily for 7 days before ascent and 2 days during mountaineering
Other Name: Starch
|
|
Active Comparator: Placebo-Rhodiola crenulata sequence
Placebo for the first treatment period and Rhodiola crenulata for the second treatment period, with a washout period of 4 months. Overall study population were 120 subjects, who were randomised and allocated into 2 sequences.
|
Drug: Rhodiola crenulata
Rhodiola crenulata:capsules, 800 mg daily for 7 days before ascent and 2 days during mountaineering
Other Names:
Drug: placebo
Placebo:capsules, 800 mg daily for 7 days before ascent and 2 days during mountaineering
Other Name: Starch
|
Detailed Description:
The number of people traveling to altitude for work or for recreation is rising, and increased media attention towards these activities has also raised the profile of altitude related illness. The most effective preventive measure for acute mountain sickness (AMS)—gradual ascent—is frequently difficult or impractical for modern international travel to locations such as Lhasa in Tibet (3650 m) and La Paz in Bolivia (3740 m). In order to solve this problem, prophylactic acetazolamide was most commonly used. But prescription needed and side effects such as paresthesia and nausea are the disadvantage of using acetazolamide. Some over-the-counter herbal supplements with essentially no adverse effect were widely used, such as Rhodiola species. Rhodiola crenulata are widely used to prevent AMS in Himalayan areas and Lhasa in Tibet but none was examined by human study. The investigators conducted a randomized, double blind, placebo controlled, crossover study to investigate the efficacy of Rhodiola crenulata in preventing AMS.
Eligibility| Ages Eligible for Study: | 20 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- age between 20 and 55 years.
- able to complete the study protocol of 9-day study regimens and mountain climbing twice.
- no prophylactic medication or herb one month before ascent.
maintaining the same living conditions and habits four months before the first mountain climbing and four months between two mountaineering.
- living in the same altitude or within a difference of 200 meters.
- no additional physical training.
- no plan to gain or loss weight.
- no altitude exposure above 2500m.
Exclusion Criteria:
- any history of chronic obstructive pulmonary disease, heart failure, cerebral neoplasm, mania, renal or hepatic insufficiency.
- women in pregnancy or intending of pregnancy during the 4-month study period.
Contacts and Locations| Taiwan | |
| Dept of Emergency medicine, Chang Gung Memorial Hospital | |
| Kweishan, Taoyuan, Taiwan, 333 | |
| Principal Investigator: | Te-Fa Chiu, MD | Chang Gung Memorial Hospital |
More Information
Additional Information:
Publications:
| Responsible Party: | Chang Gung Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT01536288 History of Changes |
| Other Study ID Numbers: | NSC 99-3114-B-182A-002 |
| Study First Received: | February 16, 2012 |
| Last Updated: | February 21, 2012 |
| Health Authority: | Taiwan : Food and Drug Administration |
Keywords provided by Chang Gung Memorial Hospital:
|
acute mountain sickness AMS Rhodiola Crenulata |
mountaineering pulse oximetry oxygen saturation |
Additional relevant MeSH terms:
|
Altitude Sickness Environmental Illness Respiration Disorders |
Respiratory Tract Diseases Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013