Brief Title
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.
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Incidence measured by Lake Louise acute mountain sickness score (LLS) ≥ 3 with headache and one other symptom.
Secondary Outcome
blood oxygen content
Condition
Acute Mountain Sickness
Intervention
Rhodiola crenulata
Study Arms / Comparison Groups
Rhodiola crenulata-placebo sequence
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
125
Start Date
October 2010
Completion Date
May 2011
Primary Completion Date
May 2011
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.
Gender
All
Ages
20 Years - 55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Te-Fa Chiu, MD, ,
Location Countries
Taiwan
Location Countries
Taiwan
Administrative Informations
NCT ID
NCT01536288
Organization ID
NSC 99-3114-B-182A-002
Responsible Party
Sponsor
Study Sponsor
Chang Gung Memorial Hospital
Collaborators
National Science Council, Taiwan
Study Sponsor
Te-Fa Chiu, MD, Principal Investigator, Chang Gung Memorial Hospital
Verification Date
November 2011