The Use of a Water Soluble Under the Tongue (Sublingual)... | NCT04088929

NCT04088929

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CBD for Treatment of Diabetic Neuropathic Pain	Experimental	Patients are instructed to take 3 total tablets a day, under the tongue, six hours apart for three weeks. Patients are to enter their pain scale score into the smartphone app as instructed during the initial site visit. Patients are to enter into the notes section of the app any additional information such as side effects (positive or negative), medication changes.	Drug: CBD

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CBD	Drug	A water-soluble sublingual tablet containing 20 mg of cannabidiol (CBD) and 0.1 mg of a proprietary blend of terpenes.	CBD for Treatment of Diabetic Neuropathic Pain

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Impact of Pure Green CBD tablets on diabetic neuropathy pain using a daily self-reported pain scale score.	To evaluate the safety and efficacy of Pure Green CBD sublingual tablets for the treatment of chronic diabetic neuropathic pain patients by evaluating their daily pain scale score reported as 0-10 where 0 is no pain and 10 is the worst pain possible as self-reported with every dose taken by the patient in the smart phone app. The objective is to reduce the patients average daily pain scale score to less than 5.	Three Weeks

Secondary Outcomes

Measure	Description	Time Frame
Impact of Pure Green CBD tablets on the quality of life of Diabetic Neuropathy Patients	To evaluate the impact of Pure Green CBD sublingual tablets on the quality of life of diabetic neuropathy patients measured by World Health Organization's quality of life questionnaire, . The objective is to examine quality of life metrics: overall quality of life and general health, physical health, psychological, social, and environment as measured on a 1-5 scale before and after the study.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject is at least 21 years of age;
Subject has a diagnosis of chronic diabetic neuropathic pain condition as determined by the subject's health care or allied health provider for which medications other than cannabis, cannabinoids, or cannabis-based medicines are currently utilized;
Subject has a 7-day average pain scale score (recorded during the screening period) of ≥ 5;
If female, subject is postmenopausal (> 1 year), surgically sterile, or practicing an approved method of birth control throughout the study and for 5 months (150 days) after the last dose of study drug;
If female and of childbearing potential, subject has a denied pregnancy and has no desire to become pregnant throughout the duration of the study;
Subject is willing and able to provide his/her written informed consent to participate in the study as stated in the informed consent document;
Subject has access to a smart phone and knows how to use smart phone applications.

Exclusion Criteria:

Subject is pregnant or lactating;
Subject has an allergy to cannabis, the Cannabaceae plant family (e.g., hemp, hops, hackberry), PEA, terpenes, peppermint;
Subject has a known allergy to active or inert ingredients of Pure Green tablets;
Subject is currently treating their pain with cannabis, cannabinoids, cannabis-base medicine;
Subject is taking a concomitant medication or treatment that would complicate use or interpretation of the study drug's effects (examples include: Cannabis or any cannabinoid products; Any drug or herbal product that influences the endocannabinoid system (ECS));
Subject is taking marijuana (cannabis) in any form, chemicals or extracts or foods or beverages or topical creams, lotions, gels, patches containing marijuana (cannabinoids, or and cannabis derivatives) including synthetic marijuana and/or CBD for at least 30 days prior to this study., and does not promise to not take marijuana (cannabis) in any form, chemicals or extracts or foods or beverages or topical creams, lotions, gels, patches containing marijuana (cannabinoids, or and cannabis derivatives) including synthetic marijuana and/or CBD while participating in this study;
Subject is currently being treated with antibiotics for sinus, throat, or lung infections;
Subject has shortness of breath associated with allergies;
Subject has uncontrolled asthma;
Subject has a fever and/or productive cough;
Subject does not have access to a smart phone or does not know how to use a smart phone application.

Name	Affiliation	Role
Debra Kimless, M.D.	Pure Green, LLC	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Dr. Nakadar's Office		Sterling Heights	Michigan	48310	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12577252	Background	Quattrini C, Tesfaye S. Understanding the impact of painful diabetic neuropathy. Diabetes Metab Res Rev. 2003 Jan-Feb;19 Suppl 1:S2-8. doi: 10.1002/dmrr.360.
22608666	Background	Callaghan BC, Cheng HT, Stables CL, Smith AL, Feldman EL. Diabetic neuropathy: clinical manifestations and current treatments. Lancet Neurol. 2012 Jun;11(6):521-34. doi: 10.1016/S1474-4422(12)70065-0. Epub 2012 May 16.

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Mar 23, 2021			Apr 16, 2021
Apr 19, 2021

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D048909	Diabetes Complications