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

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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