The Trial
Trial Background
Approximately eight months ago, the Senior Research Scientist, Steven Evans, of the non-profit Therapeutics Research Institute (TRI) began an investigation into the etiology of Parkinson's Disease (PD), using the published per-reviewed medical literature. The goal was to identify possible dietary supplement strategies that might beneficially address the quality of life issues for PD patients. This effort led to a complex plan by Evans, and a participant was enlisted to try this regimen as a Case Study [Case Study #1 or CS#1]. This case study indicated that dietary supplements could in fact possibly favorable impact the Parkinson's condition.
About the same time, a research colleague of Evans following the same medical research trail had devised a single detoxifying agent [Formula #12] and had independently undertaken to demonstrate its effectiveness as a quality of life adjunct for PD patients. Evans recognized immediately that the far more complicated and difficult regimen he constructed for CS#1 was for all intent and purposes streamlined from more than a dozen supplements used by CS#1 to just one [Formula #12] and also offered improved impact. Evans switched CS#1 to Formula #12 the past four months, documenting continued efficacy in terms of eliminating most symptoms to the largest degree. At the same time, Evans’ colleague had been also doing a number of case studies, over a two year period, experiencing the overall same outcomes without exception with those who had PD diagnosed within approximately five years or so. During this time, no side effects have been reported. On the other hand, Formula #12 appears to have no impact on those with PD who have had the disease a much longer period of time (perhaps 10 years or more although we do not know just where this cross-over point is precisely). Thus TRI wishes to undertake a mini-trial as a Proof of Concept, collecting data from approximately 30 people over a 21 day period, to assess the impact of this dietary supplement (Formula #12) on PD symptoms — for those who have not had PD diagnosed more than five years ago and who have some reduced quality of life.
Focus for this Trial
The Therapeutics Research Institute (TRI) wishes to identify approximately 30 individuals over the immediate short term who: (1) have PD, (2) have not been diagnosed more than approximately five years ago with PD, and (3) who would be willing to take a food supplement documented as "GRAS" ["Generally Recognized As Safe" by governmental definition] for approximately 3 weeks.
The participants would be committed to taking the doses 4 times a day and filling out a short form on any impact it might have had on any symptoms related to PD that they experience.
A participant must meet the inclusion and exclusion criteria as provided on the Enrollment Form.
Participants will receive Formula #12 without cost, may withdraw from the trial at any time, and will be monitored using a weekly Survey Form which they will check off [a check list of their current status which may take about 5 minutes to complete per week]. They will have access to a trial hotline 24x7 which TRI will monitor and answer.
If any participant is a responder and wishes to continue on product while data is assessed, and/or if the trial is favorable and another trial is designed, such responders will be offered to remain on product without cost so long as product is available while any next steps are formulated. If a larger trial goes forward, responders will be offered a preferential enrollment opportunity because there is an ethical obligation on our part that accrues to us because of the participant's prior trial involvement.
During the trial, no participant is expected to terminate any medication (including any levadopa prescriptions) they are taking. Since the goal is to determine whether Formula #12 can be a worthwhile adjunct to PD patients, it is sufficient to assess Formula #12 within an adjunct context.
Each participant will initially fill out a short medical history and list of symptomatology. Each week for three weeks they will check off a form [approximately 5 minutes] that summarizes any change in status of their symptomatlogy along with any perceived adverse effects or events. In the end, we wish to determine to what extent, if any, Formula #12 favorably impacted the quality of life of the PD participants.
| weeklysurvey.pdf | |
| File Size: | 57 kb |
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Trial results will be posted to this site for general review and inspection
[although participants' confidentiality will be strictly maintained].
