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

Acute Mountain Sickness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01536288
• Other study ID #: NSC 99-3114-B-182A-002
• Status: Completed
• Phase: Phase 2
• First received: February 16, 2012
• Last updated: February 21, 2012
• Start date: October 2010
• Est. completion date: May 2011

Study information

• Verified date: November 2011
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Mountain Sickness
• Altitude Sickness
• Environmental Illness

Intervention

Drug:
• Rhodiola crenulata
Rhodiola crenulata:capsules, 800 mg daily for 7 days before ascent and 2 days during mountaineering
• placebo
Placebo:capsules, 800 mg daily for 7 days before ascent and 2 days during mountaineering

Locations

Country	Name	City	State
Taiwan	Dept of Emergency medicine, Chang Gung Memorial Hospital	Kweishan	Taoyuan

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (28)

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. — View Citation

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. — View Citation

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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. — View Citation

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. — View Citation

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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. — View Citation

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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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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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. — View Citation

Wang S, Wang FP. [Studies on the chemical components of Rhodiola crenulata]. Yao Xue Xue Bao. 1992;27(2):117-20. Chinese. — View Citation

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. — View Citation

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. — View Citation

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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. — View Citation

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. — View Citation

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-1a 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. — View Citation

* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence measured by Lake Louise acute mountain sickness score (LLS) = 3 with headache and one other symptom.	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	Yes
Secondary	blood oxygen content	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	Yes
Secondary	severe AMS	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	Yes
Secondary	severity of headache, incidence of headache and severe headache	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	Yes

External Links

•   Acute mountain sickness, Kingnet, national web hospital
•   American college emergency physicians
•   High Altitude Medicine & Biology
•   International society of mountain medicine
•   Prevention and management of AMS, Taiwan police college
•   wilderness medicine, medicine and the spirit of adventure