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

checkorphan
Learn more about:
Acute mountain sickness
Related Clinical Trial
HIGH Altitude CArdiovascular REsearch Latin America Population Study Effect of Acetazolamide on Sleep Disordered Breathing in Lowlanders Older Than 40 Years at Altitude Effects of Melatonin on Sleep, Ventilatory Control and Cognition at Altitude. Effect of Acetazolamide on Lung Water Content by Ultrasound in Lowlanders Older Than 40 Years at Altitude Effect of Acetazolamide on Right Heart Function During Exercise in Lowlanders Older Than 40 Years at Altitude Effect of Acetazolamide on Visuo-motor Learning in Lowlanders Older Than 40 Years at Altitude Effect of Acetazolamide on Maximal Exercise Performance in Lowlanders Older Than 40 Years at Altitude Physiological Adaptations to Simulated Intermittent Altitude on Human Health and Performance Iron Status and Cardiopulmonary Physiology Effect of Acetazolamide on Right Heart Function at Rest in Lowlanders Older Than 40 Years at Altitude. Effect of Acetazolamide on Postural Control in Lowlanders Older Than 40 Years at Altitude Monitoring of the Cerebral Tissue Oxygenation and Perfusion in the Adapting Climber During Sleep in High Altitude The Psychophysiological Effect of Simulated and Terrestrial Altitude Relationship Between Succinate Dehydrogenase Mutations and High-Altitude Illness Cardio-respiratory Responses During Hypoxic Exercise in Individuals Born Prematurely Gut-microbiota Targeted Nutritional Intervention for Gut Barrier Integrity at High Altitude AZ, MZ, and the Pulmonary System Response to Hypoxia Study of the Effects of Iron Levels on the Lungs at High Altitude Effects of Aircraft Cabin Altitude on Passenger Comfort and Discomfort Three New Ideas to Protect Special Forces From the Stress of High Altitude Breathing Training to Improve Human Performance at High Altitude Oxidative Stress in Hypobaric Hypoxia Safety Evaluation of Aminophylline and Methazolamide Decompression Tables for Diving at Altitude Chronic Mountain Sickness, Systemic Vascular Function Evaluation of the Prevention and Treatment Effects of Chinese Medicine on High Altitude Illness Inhaled Budesonide for Altitude Illness Prevention Sickness Evaluation at Altitude With Acetazolamide at Relative Doses Prevention of Altitude Illness With Non-steroidal Anti-inflammatory Study (PAINS) Spectroscopic and Diffusion Weighted Analysis of the Effects of Dexamethasone on High Altitude Cerebral Oedema (HACE) Drug Combination on Exercise Performance at High Altitude Acclimatization Mechanisms During Ascent to 7500m Prevention of Acute Mountain Sickness by Intermittent Hypoxia Sickness Evaluation at Altitude With Acetazolamide at Relative Dosages Study Looking at End Expiratory Pressure for Altitude Illness Decrease (SLEEP-AID) Can Rhodiola Crenulata Intake Improve Oxygen Saturation and Decrease the Incidence of Acute Mountain Sickness Comparison of Metoclopramide and Ibuprofen for the Treatment of Acute Mountain Sickness A Trial of Acetazolamide Versus Placebo in Preventing Mountain Sickness During Rapid Ascent Training in Hypoxia to Prevent Acute Mountain Sickness Study of Compound Danshen Dripping Pills to Treat Acute Mountain Sickness Altitude Sickness Prevention With Ibuprofen Relative to Acetazolamide and Treatment Efficacy Controlled Hyperventilation as Prophylaxis for Acute Mountain Sickness Inhaled Budesonide and Acute Mountain Sickness Altitude Sickness Prevention and Efficacy of Comparative Treatments Alternative Treatments in Acute Mountain Sickness Effect of Acetazolamide on Acute Mountain Sickness in Lowlanders Older Than 40 Years Safety and Efficacy of T89 in Prevention and Treatment of Adults With Acute Mountain Sickness (AMS)

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