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/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
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Details
1 Kyung Hee University, Center for Clinical Research and Genomics, College of Oriental Medicine and Institute of Oriental Medicine, Seoul, Republic of Korea (GRID:grid.289247.2) (ISNI:0000000121717818)
2 Semyung University, Chungbuk, Department of Internal Medicine, College of Oriental Medicine, Bongbang-dong, (GRID:grid.443977.a) (ISNI:0000 0004 0533 259X)
3 National Evidence-based Healthcare Collaborating Agency, Wonnam-dong, Health Technology Assessment Research Division, Seoul, (GRID:grid.443977.a)