3rd Party Double Blind Clinical Research Study
The following data is an excerpt from a double-blind clinical research project conducted by an independent, third party facility to determine the efficacy of an all natural supplement, as noted by all 50 research participants, on a proprietary liquid formula with food and herbal extracts including a concentrated source of aloe vera, cinnamon extract, green tea extract, hyssop extract, and a patented form of chromium.
Week 1-4 of clinical study – There was a 30% improvement in energy.
Week 5-12 of clinical study – Overall patients noted a 60% improvement.
Week 1-4 – There was a 20% improvement in alertness.
Week 5-12 – Overall patients noted a 60% improvement.
Week 1-4 – There was a 20% improvement in libido.
Week 5-12 – Overall patients noted a 50% improvement.
Week 1-4 – There was a 50% improvement in mood.
Week 5-12 – Overall patients noted a 65% improvement.
Week 1-4 – There was a 30% improvement in sleep.
Week 5-12 – Overall patients noted a 60% improvement.
Week 1-4 – There was a 20% improvement in diet.
Week 5-12 – Overall patients noted a 50% improvement.
Week 1-4 – There was a 50% improvement in overall well-being.
Week 5-12 – Overall patients noted a 75% improvement.
Within the 12 week period – provided support for healthy glucose metabolism (up to 50%)
Within the 12 week period – provided support for healthy immune function (up to 30%)
Within the 12 week period – Provided nutritive support for healthy blood lipid levels (up to 25%)
Based on the above findings contained in this study, the ingredients were shown to have a positive impact on many quality of life issues.
Research Subjects, Design & Methods
There were a total of 50 patients consisting of men and women between the ages of 29 and 84 with Type I or Type II Diabetes. 25 patients received the ingredients and 25 patients received a placebo. All patients were randomized. Investigator and personnel were blinded to assure accuracy. Patients signed an informed consent and all results were based upon patient’s compliance and completion of the study. All 50 patients are current patients of Pennsbury Family Medical Centers.
To determine efficacy of the liquid herbal formula this study was a double blind, 3-month (90 day) trial.
Many companies do their own “in house” studies and many times those results can be incorrect, misleading, or skewed. This research on the formula blend was done by a 3rd party, independent, FDA-approved, regulated clinical facility meeting all the highest standards for studying prescription and non-prescription medications. Other studies conducted by this facility:
1. Adventis – Hypertension 2. Novaris-Value – Hypertension 3. Novartis-Navigator – Hypotension and Diabetes 4. Novartis-Select – Elderly Systolic Hypertension 5. Pfizer at Goal – Lipitor 6. Pflzer-Azithromycin – four indications pharyngitis, CAP, bronchitis and pneumonia 7. Glaxo-Smith Kline – COPD 8. Glaxo-Smith Kline – Hypertension, Diabetes 9. Ortho-McNeil – Bronchitis
This trial has Internal Review Board (IRB) approval to guarantee all patients’ rights are protected and research studies are implemented and conducted in accordance with FDA guidelines.
Patients’ selection was not based on race, color, or socio-economic status.
Dr. David J. Miller and staff monitored all patients’ symptoms.
Important Scale
• Included 0% to 100% improvement to be checked weekly for the 12-week trial period. • All patient-scoring systems were performed with the the 3rd party clinical research team to assure accuracy and to limit patient bias, thereby allowing this design study to be statistically significant.
Statistical Plan Reference 17 — 20
Standard randomization was performed to ensure proper randomization.
All data was entered into a Microsoft Access database, while all statistical analyses were performed using the PC version of Statistical Analysis System.
Baseline characteristics were compared using the Mantel-Haenszel chi-square test except for small cell sizes, where the Fisher’s exact test was employed, for categorical parameters and the two-sample t-test for continuous parameters. Statistical significance was set at five percent (or 0.05).
Outcomes of both the tools were analyzed using nonparametric procedures, such as the Wilcoxon Rank sum tests and two-group t-tests for the means of the various questions for the two groups. Statistical significance was established that a trend will be between 0.05 1 and 0.10 while true significance will be defined as equal to or less than 0.05. Subscales for the SF-36 were calculated according to Ware’s manuals and compared using tests for means.
