The efficacy and safety study of dietary supplement PURIAM110 on non-insulin taking Korean adults in the stage of pre-diabetes and diabetes mellitus: Protocol for a randomized, double-blind, placebo-controlled, and multicenter trial-pilot study

Trials

Volumn 12, Issue , 2011, Pages

  Park, Sunju ^a   Park, Jeong Su ^a   Go, Hoyeon ^b   Jang, Bo Hyoung ^c   Shin, Yongcheol ^a   Ko, Seong Gyu ^a  

^a Kyung Hee University   (South Korea)

^b Semyung University   (South Korea)

^c National Evidence Based Healthcare Collaborating Agency   (South Korea)

Author keywords

[No Author keywords available]

Indexed keywords

HERBACEOUS AGENT; PLACEBO; PURIAM 110; UNCLASSIFIED DRUG; ANTIDIABETIC AGENT; PLANT MEDICINAL PRODUCT;

ADULT; AGED; ARTICLE; DIABETES MELLITUS; DIET SUPPLEMENTATION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEMALE; HUMAN; IMPAIRED GLUCOSE TOLERANCE; MALE; MULTICENTER STUDY; PILOT STUDY; RANDOMIZED CONTROLLED TRIAL; SOUTH KOREA; ADOLESCENT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; METHODOLOGY; MIDDLE AGED; NON INSULIN DEPENDENT DIABETES MELLITUS; PLACEBO EFFECT; TIME; TREATMENT OUTCOME;

ADOLESCENT; ADULT; AGED; DIABETES MELLITUS, TYPE 2; DIETARY SUPPLEMENTS; DOUBLE-BLIND METHOD; FEMALE; HUMANS; HYPOGLYCEMIC AGENTS; MALE; MIDDLE AGED; PILOT PROJECTS; PLACEBO EFFECT; PLANT PREPARATIONS; PREDIABETIC STATE; REPUBLIC OF KOREA; RESEARCH DESIGN; TIME FACTORS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 79751528509     PISSN: 17456215     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-12-38     Document Type: Article

References (30)

1. Hsueh WA, Orloski L, Wyne K. Prediabetes: the importance of early identification and intervention. Postgrad Med 2010, 122:129-143. 10.3810/pgm.2010.07.2180, 20675976.
2. Gillman MW. Predicting prediabetes and diabetes: can we do it? Is it worth it?. Arch Pediatr Adolesc Med 2010, 164:198-199. 10.1001/archpediatrics.2009.270, 20124151.
3. Alberti KG, Zimmet PZ. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diabet Med 1998, 15:539-553. 10.1002/(SICI)1096-9136(199807)15:7<539::AID-DIA668>3.0.CO;2-S, 9686693.
4. Kim SM, Lee JS, Lee J, Na JK, Han JH, Yoon DK, Baik SH, Choi DS, Choi KM. Prevalence of diabetes and impaired fasting glucose in Korea: Korean National Health and Nutrition Survey 2001. Diabetes Care 2006, 29:226-231. 10.2337/diacare.29.02.06.dc05-0481, 16443864.
5. Report of the expert committee on the diagnosis and classification of diabetes mellitus. Diabetes Care 2003, 26(Suppl 1):S5-20.
6. Annual report on the cause of death statistics. Book Annual report on the cause of death statistics (Editor ed.^eds.) 2008, City: Statistics Korea.
7. Harris MI, Flegal KM, Cowie CC, Eberhardt MS, Goldstein DE, Little RR, Wiedmeyer HM, Byrd-Holt DD. Prevalence of diabetes, impaired fasting glucose, and impaired glucose tolerance in U.S. adults. The Third National Health and Nutrition Examination Survey, 1988-1994. Diabetes Care 1998, 21:518-524. 10.2337/diacare.21.4.518, 9571335.
8. Grant SJ, Bensoussan A, Chang D, Kiat H, Klupp NL, Liu JP, Li X. Chinese herbal medicines for people with impaired glucose tolerance or impaired fasting blood glucose. Cochrane Database Syst Rev 2009, CD006690.
9. Cho NH. The epidemiology of diabetes in Korea: from the economics to genetics. Korean Diabetes J 2010, 34:10-15. 10.4093/kdj.2010.34.1.10, 2879903, 20532014.
10. Kim CH. Early insulin secretory dysfunction in korean prediabetic subjects: should we change the criteria for "prediabetes?". Korean Diabetes J 2010, 34:154-156. 10.4093/kdj.2010.34.3.154, 2898928, 20617075.
11. Gavi S, Hensley J. Diagnosis and management of type 2 diabetes in adults: a review of the ICSI guideline. Geriatrics 2009, 64:12-17. 29.
12. Li WL, Zheng HC, Bukuru J, De Kimpe N. Natural medicines used in the traditional Chinese medical system for therapy of diabetes mellitus. J Ethnopharmacol 2004, 92:1-21. 10.1016/j.jep.2003.12.031, 15099842.
13. Yeh GY, Eisenberg DM, Kaptchuk TJ, Phillips RS. Systematic review of herbs and dietary supplements for glycemic control in diabetes. Diabetes Care 2003, 26:1277-1294. 10.2337/diacare.26.4.1277, 12663610.
14. Shapiro K, Gong WC. Natural Products Used for Diabetes. J Am Pharm Assoc 2002, 42:217-226.
15. Malviya N, Jain S, Malviya S. Antidiabetic potential of medicinal plants. Acta Pol Pharm 2010, 67:113-118.
16. Hunt LM, Arar NH, Akana LL. Herbs, Prayer, and Insulin Use of Medical and Alternative Treatments by a Group of Mexican American Diabetes Patients. J Fam Pract 2000, 49:216-223.
17. Jung UJ, Lee MK, Jeong KS, Choi MS. The hypoglycemic effects of hesperidin and naringin are partly mediated by hepatic glucose-regulating enzymes in C57BL/KsJ-db/db mice. J Nutr 2004, 134:2499-2503.
18. Jung UJ, Lee MK, Park YB, Kang MA, Choi MS. Effect of citrus flavonoids on lipid metabolism and glucose-regulating enzyme mRNA levels in type-2 diabetic mice. Int J Biochem Cell Biol 2006, 38:1134-1145. 10.1016/j.biocel.2005.12.002, 16427799.
19. Kim H. Herbal pharmacology. 2001, Seoul: Jipmoondang.
20. Orange Fruit. , http://www.fzrm.com/plantextracts/Orange%20_Fruit_extract.htm
21. Andallu B, Suryakantham V, Lakshmi Srikanthi B, Reddy GK. Effect of mulberry (Morus indica L.) therapy on plasma and erythrocyte membrane lipids in patients with type 2 diabetes. Clin Chim Acta 2001, 314:47-53. 10.1016/S0009-8981(01)00632-5, 11718678.
22. Andallu B, Varadacharyulu N. Antioxidant role of mulberry (Morus indica L. cv. Anantha) leaves in streptozotocin-diabetic rats. Clin Chim Acta 2003, 338:3-10. 10.1016/S0009-8981(03)00322-X, 14637259.
23. Muberry Leaf. , http://www.fzrm.com/plantextracts/Muberry_Leaf_extract.htm
24. Traditional medicine college textbook compilation committee of herbology Herbology. 2007, Seoul: Yeongnimsa, Traditional medicine college textbook compilation committee of herbology.
25. Wood DM, Athwal S, Panahloo A. The advantages and disadvantages of a 'herbal' medicine in a patient with diabetes mellitus: a case report. Diabet Med 2004, 21:625-627. 10.1111/j.1464-5491.2004.01202.x, 15154951.
26. Diagnosis and classification of diabetes mellitus. Diabetes Care 2010, 33(Suppl 1):S62-69. 2797383, 20042775.
27. Kim JI, Kim JC, Kang MJ, Lee MS, Kim JJ, Cha IJ. Effects of pinitol isolated from soybeans on glycaemic control and cardiovascular risk factors in Korean patients with type II diabetes mellitus: a randomized controlled study. Eur J Clin Nutr 2005, 59:456-458. 10.1038/sj.ejcn.1602081, 15536472.
28. World Health Organization WHO International Standard Terminologies on Traditional Medicine in the Western Pacific Region. Geneva 2007, World Health Organization.
29. Liu JC, Chan P, Hsu FL, Chen YJ, Hsieh MH, Lo MY, Lin JY. The in vitro inhibitory effects of crude extracts of traditional Chinese herbs on 3-hydroxy-3-methylglutaryl-coenzyme A reductase on Vero cells. Am J Chin Med 2002, 30:629-636. 10.1142/S0192415X02000454, 12568290.
30. Seo HJ, Jeong KS, Lee MK, Park YB, Jung UJ, Kim HJ, Choi MS. Role of naringin supplement in regulation of lipid and ethanol metabolism in rats. Life Sci 2003, 73:933-946. 10.1016/S0024-3205(03)00358-8, 12798418.