Proposed Clinical Studies (Outline)

All studies conducted by the Institute for Green Science Research (IGSR) are intended to be “observational” in nature unless otherwise specified. Studies will be “double-blind crossover” when appropriate.

We will solve what we believe to be the most critical issues when undertaking any review of Cannabis and the subsequent effects of its “major” components (THC, CBD, CBN, CBG etc.).

  • Legal Issues: Navigation of the legalities involved
  • Consistency and Professionalism:
    1. “Consistent” products (grow strains- with equivalent ratios of the “major” chemicals components),
    2. Utilizing a safe “consistent” process (CO2 extraction) to obtain a “consistent” product.
    3. Utilizing licensed professionals to compound/manufacture final products according to standards as set forth by the United States Pharmacopoeia (USP) in chapter 797. These products may be capsules, troches, sprays, oils, drops and topical creams.
  • “Clean” products. The products we use will be tested and certified as pesticide and Heavy Metal free! These products will serve as our “knowns.”
  • Laboratory assessment (in addition to subjective data). It is our goal to utilize laboratory information to measure the following:
    1. Pesticide and Heavy Metals in the grow, extracted product and final products
    2. Patient urine samples to determine levels of active components
  • Establish product/formulation dose-response data to be used in conjunction with laboratory measures to determine product indications and dosage recommendations.

Study design and parameters including: Location, Duration, Endpoint(s) Determination, Inclusion Criteria and Exclusion Criteria for each study have yet to be determined. We anticipate that these criteria will vary for each study. Laboratory sample data will be obtained and evaluated when appropriate.

We plan to use a variety of researchers and investigators for these studies. At this point, we anticipate that most of the studies will be self-funded by IGSR.

We are currently seeking institution(s) who would like to participate with us in helping to coordinate an Institutional Review Board (IRB).

Our initial areas of interest include but are not limited to:

  • Subjective assessment of pain relief using unique manufactured capsules (“knowns”) as measured by the Visual Analog Descriptor Scale
  • Subjective assessment of the “duration of action” obtained from the proprietary formulation of “Time-Release” PAIN capsules vs. “Non-Time Release”
  • Subjective assessment of pain relief achieved from the proprietary topical pain cream using the Verbal Descriptor Scale
  • Degree of relief from depression using the proprietary  “enhanced” product as measured by the “Beck Depression Inventory”
  • Degree of relief from anxiety using proprietary formulated capsules. The “Hamilton Anxiety Rating Scale” will be used to measure effectiveness.