Clinical trial NCT01536288: Can Rhodiola Crenulata Intake Improve Oxygen Saturation and Decrease the Incidence of Acute Mountain Sickness
Official title: Can Rhodiola Crenulata Intake Improve Oxygen Saturation and Decrease the Incidence of Acute Mountain Sickness.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Mountain Sickness
Environmental Illness
Keywords: acute mountain sickness
AMS
Rhodiola Crenulata
mountaineering
pulse oximetry
oxygen saturation
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2012-02-22
Enrollment: 125
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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 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 criteria: 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.

Primary outcomes:
measure: Incidence measured by Lake Louise acute mountain sickness score (LLS) ≥ 3 with headache and one other symptom.
timeFrame: within 18 hours after ascent to altitude 3100m
Secondary outcomes:
measure: blood oxygen content
timeFrame: on arrival of altitude 3100m
measure: severe AMS
timeFrame: within 18 hours after ascent to altitude 3100m
measure: severity of headache, incidence of headache and severe headache
timeFrame: Within 18 hours after ascent to altitude 3100m
Other outcomes:
Locations:
city: Kweishan
country: Taiwan
facility: Dept of Emergency medicine, Chang Gung Memorial Hospital
state: Taoyuan
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Te-Fa Chiu, MD
role: PRINCIPAL_INVESTIGATOR
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