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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01536288
First Posted: February 22, 2012
Last Update Posted: February 22, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
  Purpose
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.

Condition Intervention Phase
Acute Mountain Sickness Environmental Illness Drug: Rhodiola crenulata Drug: placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Can Rhodiola Crenulata Intake Improve Oxygen Saturation and Decrease the Incidence of Acute Mountain Sickness.

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

  • 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.

  • 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)


Enrollment: 125
Study Start Date: October 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Starch

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01536288


Locations
Taiwan
Dept of Emergency medicine, Chang Gung Memorial Hospital
Kweishan, Taoyuan, Taiwan, 333
Sponsors and Collaborators
Chang Gung Memorial Hospital
National Science Council, Taiwan
Investigators
Principal Investigator: Te-Fa Chiu, MD Chang Gung Memorial Hospital
  More Information

Additional Information:
Publications:
Hackett PH, Roach RC. High-altitude illness. N Engl J Med. 2001 Jul 12;345(2):107-14. Review.
Imray C, Booth A, Wright A, Bradwell A. Acute altitude illnesses. BMJ. 2011 Aug 15;343:d4943. doi: 10.1136/bmj.d4943. Review.
Chow T, Browne V, Heileson HL, Wallace D, Anholm J, Green SM. Ginkgo biloba and acetazolamide prophylaxis for acute mountain sickness: a randomized, placebo-controlled trial. Arch Intern Med. 2005 Feb 14;165(3):296-301.
Hackett PH, Rennie D, Levine HD. The incidence, importance, and prophylaxis of acute mountain sickness. Lancet. 1976 Nov 27;2(7996):1149-55.
Zell SC, Goodman PH. Acetazolamide and dexamethasone in the prevention of acute mountain sickness. West J Med. 1988 May;148(5):541-5.
Dumont L, Mardirosoff C, Tramèr MR. Efficacy and harm of pharmacological prevention of acute mountain sickness: quantitative systematic review. BMJ. 2000 Jul 29;321(7256):267-72. Review.
Basnyat B, Gertsch JH, Holck PS, Johnson EW, Luks AM, Donham BP, Fleischman RJ, Gowder DW, Hawksworth JS, Jensen BT, Kleiman RJ, Loveridge AH, Lundeen EB, Newman SL, Noboa JA, Miegs DP, O'Beirne KA, Philpot KB, Schultz MN, Valente MC, Wiebers MR, Swenson ER. Acetazolamide 125 mg BD is not significantly different from 375 mg BD in the prevention of acute mountain sickness: the prophylactic acetazolamide dosage comparison for efficacy (PACE) trial. High Alt Med Biol. 2006 Spring;7(1):17-27.
Imray C, Wright A, Subudhi A, Roach R. Acute mountain sickness: pathophysiology, prevention, and treatment. Prog Cardiovasc Dis. 2010 May-Jun;52(6):467-84. doi: 10.1016/j.pcad.2010.02.003. Review.
Leadbetter G, Keyes LE, Maakestad KM, Olson S, Tissot van Patot MC, Hackett PH. Ginkgo biloba does--and does not--prevent acute mountain sickness. Wilderness Environ Med. 2009 Spring;20(1):66-71. doi: 10.1580/08-WEME-BR-247.1.
Gertsch JH, Basnyat B, Johnson EW, Onopa J, Holck PS. Randomised, double blind, placebo controlled comparison of ginkgo biloba and acetazolamide for prevention of acute mountain sickness among Himalayan trekkers: the prevention of high altitude illness trial (PHAIT). BMJ. 2004 Apr 3;328(7443):797. Epub 2004 Mar 11.
Gertsch JH, Seto TB, Mor J, Onopa J. Ginkgo biloba for the prevention of severe acute mountain sickness (AMS) starting one day before rapid ascent. High Alt Med Biol. 2002 Spring;3(1):29-37.
van Patot MC, Keyes LE, Leadbetter G 3rd, Hackett PH. Ginkgo biloba for prevention of acute mountain sickness: does it work? High Alt Med Biol. 2009 Spring;10(1):33-43. doi: 10.1089/ham.2008.1085. Review.
Zhang ZJ, Tong Y, Zou J, Chen PJ, Yu DH. Dietary supplement with a combination of Rhodiola crenulata and Ginkgo biloba enhances the endurance performance in healthy volunteers. Chin J Integr Med. 2009 Jun;15(3):177-83. doi: 10.1007/s11655-009-0177-x. Epub 2009 Jul 2.
Tu Y, Roberts L, Shetty K, Schneider SS. Rhodiola crenulata induces death and inhibits growth of breast cancer cell lines. J Med Food. 2008 Sep;11(3):413-23. doi: 10.1089/jmf.2007.0736.
Nakamura S, Li X, Matsuda H, Yoshikawa M. Bioactive constituents from Chinese natural medicines. XXVIII. Chemical structures of acyclic alcohol glycosides from the roots of Rhodiola crenulata. Chem Pharm Bull (Tokyo). 2008 Apr;56(4):536-40.
Zheng KY, Guo AJ, Bi CW, Zhu KY, Chan GK, Fu Q, Xu SL, Zhan JY, Lau DT, Dong TT, Choi RC, Tsim KW. The extract of Rhodiolae Crenulatae Radix et Rhizoma induces the accumulation of HIF-1α via blocking the degradation pathway in cultured kidney fibroblasts. Planta Med. 2011 Jun;77(9):894-9. doi: 10.1055/s-0030-1250627. Epub 2010 Dec 14.
Zhao Y, Qi LW, Wang WM, Saxena PK, Liu CZ. Melatonin improves the survival of cryopreserved callus of Rhodiola crenulata. J Pineal Res. 2011 Jan;50(1):83-8. doi: 10.1111/j.1600-079X.2010.00817.x. Epub 2010 Nov 15.
Lee OH, Kwon YI, Apostolidis E, Shetty K, Kim YC. Rhodiola-induced inhibition of adipogenesis involves antioxidant enzyme response associated with pentose phosphate pathway. Phytother Res. 2011 Jan;25(1):106-15. doi: 10.1002/ptr.3236.
Li T, Zhang H. Identification and comparative determination of rhodionin in traditional tibetan medicinal plants of fourteen Rhodiola species by high-performance liquid chromatography-photodiode array detection and electrospray ionization-mass spectrometry. Chem Pharm Bull (Tokyo). 2008 Jun;56(6):807-14.
Li T, Zhang H. Application of microscopy in authentication of traditional Tibetan medicinal plants of five Rhodiola (Crassulaceae) alpine species by comparative anatomy and micromorphology. Microsc Res Tech. 2008 Jun;71(6):448-58. doi: 10.1002/jemt.20570.
Kwon YI, Jang HD, Shetty K. Evaluation of Rhodiola crenulata and Rhodiola rosea for management of type II diabetes and hypertension. Asia Pac J Clin Nutr. 2006;15(3):425-32.
Panossian A, Wikman G, Sarris J. Rosenroot (Rhodiola rosea): traditional use, chemical composition, pharmacology and clinical efficacy. Phytomedicine. 2010 Jun;17(7):481-93. doi: 10.1016/j.phymed.2010.02.002. Epub 2010 Apr 7. Review.
Wang S, Wang FP. [Studies on the chemical components of Rhodiola crenulata]. Yao Xue Xue Bao. 1992;27(2):117-20. Chinese.
Wang S, You XT, Wang FP. [HPLC determination of salidroside in the roots of Rhodiola genus plants]. Yao Xue Xue Bao. 1992;27(11):849-52. Chinese.
Wang SH, Chen YC, Kao WF, Lin YJ, Chen JC, Chiu TF, Hsu TY, Chen HC, Liu SW. Epidemiology of acute mountain sickness on Jade Mountain, Taiwan: an annual prospective observational study. High Alt Med Biol. 2010 Spring;11(1):43-9. doi: 10.1089/ham.2009.1063.
Karinen HM, Peltonen JE, Kähönen M, Tikkanen HO. Prediction of acute mountain sickness by monitoring arterial oxygen saturation during ascent. High Alt Med Biol. 2010 Winter;11(4):325-32. doi: 10.1089/ham.2009.1060.
Roach RC, Greene ER, Schoene RB, Hackett PH. Arterial oxygen saturation for prediction of acute mountain sickness. Aviat Space Environ Med. 1998 Dec;69(12):1182-5.
Jackson SJ, Varley J, Sellers C, Josephs K, Codrington L, Duke G, Njelekela MA, Drummond G, Sutherland AI, Thompson AA, Baillie JK. Incidence and predictors of acute mountain sickness among trekkers on Mount Kilimanjaro. High Alt Med Biol. 2010 Fall;11(3):217-22. doi: 10.1089/ham.2010.1003.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01536288     History of Changes
Other Study ID Numbers: NSC 99-3114-B-182A-002
First Submitted: February 16, 2012
First Posted: February 22, 2012
Last Update Posted: February 22, 2012
Last Verified: November 2011

Keywords provided by Chang Gung Memorial Hospital:
acute mountain sickness
AMS
Rhodiola Crenulata
mountaineering
pulse oximetry
oxygen saturation

Additional relevant MeSH terms:
Altitude Sickness
Environmental Illness
Respiration Disorders
Respiratory Tract Diseases
Hypersensitivity
Immune System Diseases
Disorders of Environmental Origin


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