Acute Mountain Sickness Clinical Trial
Official title:
Can Rhodiola Crenulata Intake Improve Oxygen Saturation and Decrease the Incidence of Acute Mountain Sickness.
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 |
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.
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Taiwan | Dept of Emergency medicine, Chang Gung Memorial Hospital | Kweishan | Taoyuan |
Lead Sponsor | Collaborator |
---|---|
Chang Gung Memorial Hospital | National Science Council, Taiwan |
Taiwan,
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
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. — View Citation
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
Hackett PH, Rennie D, Levine HD. The incidence, importance, and prophylaxis of acute mountain sickness. Lancet. 1976 Nov 27;2(7996):1149-55. — View Citation
Hackett PH, Roach RC. High-altitude illness. N Engl J Med. 2001 Jul 12;345(2):107-14. Review. — View Citation
Imray C, Booth A, Wright A, Bradwell A. Acute altitude illnesses. BMJ. 2011 Aug 15;343:d4943. doi: 10.1136/bmj.d4943. Review. — View Citation
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. — View Citation
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
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. — View Citation
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
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. — View Citation
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. — View Citation
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
Zell SC, Goodman PH. Acetazolamide and dexamethasone in the prevention of acute mountain sickness. West J Med. 1988 May;148(5):541-5. — View Citation
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04111263 -
Gut-microbiota Targeted Nutritional Intervention for Gut Barrier Integrity at High Altitude
|
N/A | |
Completed |
NCT01842906 -
Study Looking at End Expiratory Pressure for Altitude Illness Decrease (SLEEP-AID)
|
N/A | |
Completed |
NCT00326703 -
Effects of Aircraft Cabin Altitude on Passenger Comfort and Discomfort
|
N/A | |
Completed |
NCT06310642 -
Efficacy of Prophylactic Treatment of Oral Prochlorperazine for Acute Mountain Sickness
|
Phase 4 | |
Completed |
NCT03561675 -
Effect of Acetazolamide on Acute Mountain Sickness in Lowlanders Older Than 40 Years
|
Phase 4 | |
Completed |
NCT00559832 -
Prevention of Acute Mountain Sickness by Intermittent Hypoxia
|
N/A | |
Completed |
NCT00603122 -
Acclimatization Mechanisms During Ascent to 7500m
|
N/A | |
Completed |
NCT01436383 -
Oxidative Stress in Hypobaric Hypoxia
|
N/A | |
Completed |
NCT00627965 -
Randomized, Controlled Trial of Regular Sildenafil Citrate in the Prevention of Altitude Illness
|
Phase 4 | |
Completed |
NCT00664001 -
Anti-Oxidant Supplementation for the Prevention of Acute Mountain Sickness
|
Phase 3 | |
Not yet recruiting |
NCT06145113 -
The Effect of Continuous Positive Pressure Ventilation on Symptoms of Acute Mountain Sickness
|
N/A | |
Recruiting |
NCT05733338 -
The Effects of Intermittent Hypoxia on Acute Hypoxic Injury
|
N/A | |
Completed |
NCT01522326 -
Comparison of Metoclopramide and Ibuprofen for the Treatment of Acute Mountain Sickness
|
N/A | |
Recruiting |
NCT06393998 -
CO2 Supplement for Treatment of Acute Mountain Sickness
|
N/A | |
Completed |
NCT03270787 -
Study of Compound Danshen Dripping Pills to Treat Acute Mountain Sickness
|
Phase 1/Phase 2 | |
Completed |
NCT02811016 -
Inhaled Budesonide and Acute Mountain Sickness
|
Phase 1 | |
Recruiting |
NCT00886912 -
Training in Hypoxia to Prevent Acute Mountain Sickness
|
N/A | |
Terminated |
NCT03956472 -
Alternative Treatments in Acute Mountain Sickness
|
N/A | |
Recruiting |
NCT03621410 -
T89 in Prevention and Treatment of Acute Mountain Sickness (AMS) During Rapid Ascent
|
Phase 2 | |
Active, not recruiting |
NCT01565603 -
Sleep and Cerebral Responses to High Altitude
|
N/A |