Dept of Emergency medicine, Chang Gung Memorial Hospital
Kweishan, Taoyuan, 333, Taiwan
NCT Number: NCT01536288
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.
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Notify Me20 year–55 year
All sexes
Interventional
Phase 2
Kweishan, Taoyuan, 333, Taiwan
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Rhodiola crenulata:capsules, 800 mg daily for 7 days before ascent and 2 days during mountaineering
Other names: Rhodiola, Golden root, Hong Jing Tian
Placebo:capsules, 800 mg daily for 7 days before ascent and 2 days during mountaineering
Other names: Starch
Time frame: within 18 hours after ascent to altitude 3100m
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.
Time frame: on arrival of altitude 3100m
Blood oxygen content was measured by pulse oximetry (NPB 40, Nellcor, Pleasanton, CA, USA) within 1-2 hours after ascent to altitude 3100m.
Time frame: within 18 hours after ascent to altitude 3100m
Incidence measured by Lake Louise acute mountain sickness score (LLS) ≥ 5 with headache and one other symptom.
Time frame: Within 18 hours after ascent to altitude 3100m
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)
Chang Gung Memorial Hospital
Other
Can Rhodiola Crenulata Intake Improve Oxygen Saturation and Decrease the Incidence of Acute Mountain Sickness.
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