Clinical Trial: Can Rhodiola Crenulata Intake Improve Oxygen Saturation and Decrease the Incidence of Acute Mountain Sickness

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Can Rhodiola Crenulata Intake Improve Oxygen Saturation and Decrease the Incidence of Acute Mountain Sickness.

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Chang Gung Memorial Hospital

Current Primary Outcome: 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 ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • blood oxygen content [ 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.
  • severe AMS [ 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.
  • severity of headache, incidence of headache and severe headache [ 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)


Original Secondary Outcome: Same as current

Information By: Chang Gung Memorial Hospital

Dates:
Date Received: February 16, 2012
Date Started: October 2010
Date Completion:
Last Updated: February 21, 2012
Last Verified: November 2011