Wyeth Ayerst Schwartz-Pharma Johnson & Johnson Aventis
The purpose of this study was to determine Cinnergen�sTM efficacy in a controlled Phase I study. Upon completion of the case study on CinnergenTM, it was shown to have a positive effect on lowering blood sugar in a Type II Diabetic.
To determine the effects of CinnergenTM on Type I and Type II Diabetics with regard to lowering and regulating blood sugar levels. All 50 patients completed a survey questionnaire upon completion of the study regarding Quality of Life Issues.
Research Design and Methods:
There were a total of 50 randomized patients consisting of men and women between the ages of 29 and 84 with Type I Diabetes or Type II Diabetes. During the study, Twenty-five (25) patients received CinnergenTM and twenty-five (25) patients received a placebo.
The investigator and all personnel involved in the study were blinded to assure accuracy.
Patients signed an informed consent. All results are based upon patient�s compliance and completion of the study.
All 50 patients were current patients of Pennsbury Family Medical Centers.
Patients who complete the study were given the option of continuing on CinnergenTM for an additional 3 months free of charge. After the three (3) months, patients may continue on CinnergenTM for a nominal fee.
This study is a double blind phase 1, 3-month (90 day) trial performed at Bucks County Clinical Research by principal investigator Dr. David J. Miller and staff.
Please see curriculum vitae of Dr. David J. Miller, DO, FAAP, Richard M. Goldfarb, MD, FACS, and brochure of Bucks County Clinical Research as a center of excellence and innovation in clinical research by visiting the website at www.bccrinc.com.
Bucks County Clinical Research is an FDA-approved and regulated clinical facility, which meets the highest standards for studying prescription and non-prescription medications. Current on-going studies include: