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
Sunju Park, Jeong-Su Park, Hoyeon Go, Bo-Hyoung Jang, Yongcheol Shin, Seong-Gyu Ko
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/Design: 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.
Discussion: 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.
Trial Registration: ISRCTN: ISRCTN44779824
Copyright © 2001 Park et al. This is an open access article distributed under the
Creative Commons Attribution License
1. Objectives & Hypothesis
2. Study design
4. Inclusion and exclusion criteria
5. Sample size
8. Interventions: PURIAM110 is a 460 mg hard gelatin capsule, containing dried powder of bitter oranges and mulberry leaves. The dried powder is made of hot water extraction of bitter oranges and mulberry leaves 1:1 mixture followed by spray drying. The raw material extract is provided by Sun Ten pharmaceutical company (SUN TEN PHARMACEUTICAL Co., LTD.) in Taiwan.
9. Study groups
10. Study period
13. Measurement tools
14. Compliance calculation
15. Statistical analyses
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