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
2011

Study on the Efficacy and Safety of PURIAM110 for Pre-Diabetes and Diabetes

Sample size: 45 publication Evidence: low

Author Information

Author(s): Park Sunju, Park Jeong-Su, Go Hoyeon, Jang Bo-Hyoung, Shin Yongcheol, Ko Seong-Gyu

Primary Institution: Kyung Hee University

Hypothesis

We hypothesize that glucose concentration of pre-diabetes and diabetes mellitus who are treated with PURIAM110 will be lower than that of the control group.

Conclusion

The study aims to confirm the efficacy and safety of PURIAM110 as a dietary supplement for pre-diabetes and diabetes patients.

Supporting Evidence

  • Diabetes is a growing health concern in Korea, with high prevalence rates.
  • PURIAM110 is derived from orange fruits and mulberry leaves, which are believed to have health benefits.
  • This study is the first pilot study on the effects of PURIAM110 on pre-diabetes in Korean adults.

Takeaway

This study is testing a new supplement called PURIAM110 to see if it helps people with pre-diabetes and diabetes feel better and have lower blood sugar.

Methodology

This is a 6-week, double-blinded, placebo-controlled, randomized, and multi-center clinical trial.

Potential Biases

Potential bias due to the small sample size and the nature of dietary supplement trials.

Limitations

The study is a pilot trial with a small sample size and may not provide definitive evidence.

Participant Demographics

Korean adults aged 18 to 65 with pre-diabetes and non-insulin dependent diabetes.

Statistical Information

P-Value

p<0.05

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1186/1745-6215-12-38

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