title: 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.
abstract: BACKGROUND
  Diabetes has already become a threat to the nation and the individual due to its high prevalence rates and high medical expenses. Therefore, preventing diabetes at an earlier stage is very important. Despite advances in antidiabetic agents, we have not yet achieved any satisfying results in treating diabetes. Among various treatments, medicinal herbs and supplements for diabetes are reported to show generally good efficacy and safety data. In particular, PURIAM110, a compound from orange fruits and mulberry leaves, is supposed to prevent the progress of type II diabetes mellitus and improve diabetic symptoms. This is the first reported pilot study about the protective effect of the orange fruits and mulberry leaves mixture against pre-diabetes on Korean adults. Based on these positive results of herb-derived components, extended studies of dietary supplements have to be done to suggest confirmative evidences.
  
  
  METHODS
  The efficacy and safety study of PURIAM110 is a double-blinded, placebo-controlled, randomized, and multi-center clinical trial. A total of 45 subjects will participate in this study for 6 weeks.
  
  
  CONCLUSIONS
  The present protocol will confirm the efficacy and safety of PURIAM110 for pre-diabetes, suggesting more basic knowledge to conduct further randomized controlled trials (RCT). In addition, PURIAM110 can be an alternative dietary supplemental remedy for diabetes patients.
  
  
  BACKGROUND
  ISRCTN: ISRCTN44779824.
authors.affiliation: Center for Clinical Research and Genomics, College of Oriental Medicine and Institute of Oriental Medicine, Kyung Hee University, 1 Hoegi-dong, Seoul, Republic of Korea.
authors.forename: Sunju
authors.initials: S
authors.lastname: Park
authors.forename: Jeong-Su
authors.initials: JS
authors.lastname: Park
authors.forename: Hoyeon
authors.initials: H
authors.lastname: Go
authors.forename: Bo-Hyoung
authors.initials: BH
authors.lastname: Jang
authors.forename: Yongcheol
authors.initials: Y
authors.lastname: Shin
authors.forename: Seong-Gyu
authors.initials: SG
authors.lastname: Ko
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D019587:Dietary Supplements / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D015990:Placebo Effect; D028321:Plant Preparations / Q000009:adverse effects / Q000627:therapeutic use*; D011236:Prediabetic State / Q000188:drug therapy*; D056910:Republic of Korea; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D007004:Hypoglycemic Agents; D028321:Plant Preparations