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Randomized double blind clinical study.
All natural formula with clinically supported ingredients
Clinical research summary: 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.
The following data is an excerpt from a double-blind 90 day clinical study. The results were very encouraging and exciting. Take a close look at what these patients reported about the effects that the formula had upon their overall well-being and wellness.
Research data results
Increase in Energy
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.
Improvement in
Mental Alertness
Week 1-4 of clinical study
There was a 20% improvement in alertness.
Week 5-12 of clinical study
Overall patients noted a 60% improvement.
Improved Libido
Week 1-4 of clinical study
There was a 20% improvement in libido.
Week 5-12 of clinical study
Overall patients noted a 50% improvement.
Enhancement in Mood
Week 1-4 of clinical study
There was a 50% improvement in mood.
Week 5-12 of clinical study
Overall patients noted a 65% improvement.
Improvement in Sleep
Week 1-4 of clinical study
There was a 30% improvement in sleep.
Week 5-12 of clinical study
Overall patients noted a 60% improvement.
Dietary Habits
Week 1-4 of clinical study
There was a 20% improvement in diet.
Week 5-12 of clinical study
Overall patients noted a 50% improvement.
Overall Feeling of
Well-Being
Week 1-4 of clinical study
There was a 50% improvement in overall
well-being.
Week 5-12 of clinical study
Overall patients noted a 75% improvement.
Improved Blood
Glucose Levels
Within the 12 week period
provided support for healthy glucose
metabolism (up to 50%)
Immune Function Support
Within the 12 week period
provided support for healthy immune function (up to 30%)
Blood Lipids Improvement
Within the 12 week period
Provided nutritive support for healthy
blood lipid levels (up to 25%)
Methods
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.
Study subjects
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.
Study design
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:
Adventis – Hypertension
Novaris-Value – Hypertension
Novartis-Navigator – Hypo-tension and Diabetes
Novartis-Select – Elderly Systolic Hypertension
Pfizer at Goal – Lipitor
Pflzer-Azithromycin – four indications pharyngitis, CAP, bronchitis and pneumonia
Glaxo-Smith Kline – COPD
Glaxo-Smith Kline – Hypertension, Diabetes
Ortho-McNeil – Bronchitis
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