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Cannabinoid
CBD for Diabetic Neuropathy
Phase 2
Waitlist Available
Led By Debra Kimless, M.D.
Research Sponsored by Pure Green
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up four weeks
Awards & highlights
Study Summary
This study is evaluating whether a new drug may help relieve pain for individuals with diabetes.
Eligible Conditions
- Diabetic Neuropathy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ four weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~four weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of treatment-related adverse events as assessed by CTCAE v4.0
Secondary outcome measures
Anxiety as assessed by the Zung Self-Rating Anxiety Scale (SAS)
Pain as assessed by Numerical Pain Rating Scale (NPRS)
Sleep Quality as assessed by Pittsburgh Sleep Quality Index (PSQI)
+1 moreSide effects data
From 2014 Phase 2 trial • 50 Patients • NCT018446872%
headache
2%
Blurred Vision
2%
Cold Symptoms
2%
Gastrointestinal Upset
2%
anxiety
100%
80%
60%
40%
20%
0%
Study treatment Arm
Active MJ With 0 mg CBD
Active MJ With 200 mg CBD
Active MJ With 400 mg CBD
Active MJ With 800 mg CBD
Inactive MJ With 0 mg CBD
Inactive MJ With 200 mg CBD
Inactive MJ With 400 mg CBD
Inactive MJ With 800 mg CBD
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: CBDExperimental Treatment1 Intervention
Subject will receive a 28-day supply of 20 mg CBD sublingual tablets to be taken 3 times a day for 28 days.
Group II: Placebo ControlPlacebo Group1 Intervention
A placebo sublingual tablet to be taken three times a day for 28 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cannabidiol
FDA approved
Find a Location
Who is running the clinical trial?
Pure GreenLead Sponsor
5 Previous Clinical Trials
174 Total Patients Enrolled
Debra Kimless, M.D.Principal InvestigatorPure Green Pharmaceuticals
4 Previous Clinical Trials
158 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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