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

February 21, 2012 updated by: Chang Gung Memorial Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

125

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Taiwan
- Taoyuan
  - Kweishan, Taoyuan, Taiwan, 333
    - Dept of Emergency medicine, Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: Triple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Rhodiola crenulata-placebo sequence 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.	Drug: Rhodiola crenulata Rhodiola crenulata:capsules, 800 mg daily for 7 days before ascent and 2 days during mountaineering Other Names: Rhodiola Golden root Hong Jing Tian Drug: placebo Placebo:capsules, 800 mg daily for 7 days before ascent and 2 days during mountaineering Other Names: Starch
Active Comparator: Placebo-Rhodiola crenulata sequence Placebo for the first treatment period and Rhodiola crenulata 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.	Drug: Rhodiola crenulata Rhodiola crenulata:capsules, 800 mg daily for 7 days before ascent and 2 days during mountaineering Other Names: Rhodiola Golden root Hong Jing Tian Drug: placebo Placebo:capsules, 800 mg daily for 7 days before ascent and 2 days during mountaineering Other Names: Starch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	within 18 hours after ascent to altitude 3100m

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	on arrival of 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.	within 18 hours after ascent to altitude 3100m
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)	Within 18 hours after ascent to altitude 3100m

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Collaborators

National Science Council, Taiwan

Investigators

Principal Investigator: Te-Fa Chiu, MD, Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

February 16, 2012

First Submitted That Met QC Criteria

February 21, 2012

First Posted (Estimate)

February 22, 2012

Study Record Updates

Last Update Posted (Estimate)

February 22, 2012

Last Update Submitted That Met QC Criteria

February 21, 2012

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

NSC 99-3114-B-182A-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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