Determining the effect of CBDEX 10 (Cannabidiol 10:1) spray on reducing the biochemical factors of type 2 diabetes
Design
In a double-blind randomized clinical trial, 50 patients with type 2 diabetes referred to the endocrinology clinic of Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, with written written consent based on a table of random numbers. One of the two groups of drugs or placebo will be included in the study.
Settings and conduct
Patients with type 2 diabetes who refer to the endocrinology clinic of Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, will enter the study by obtaining written consent based on a table of random numbers in one of two groups of drugs or placebo.
Patients with type 2 diabetes who refer to the endocrinology clinic of Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, will enter the study by obtaining written consent based on a table of random numbers in one of two groups of drugs or placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with type 2 diabetes; age older than 18 years old; HbA1c less than 8.5%.
Exclusion criteria: pregnancy or lactation; uncontrolled seizure & untreated major depressive disorder; liver failure (child pugh B, C).
Intervention groups
Patients in the drug group are given two puffs of CBDEX 10 sublingual spray every day for eight weeks (containing 100 micrograms of CBD extract: THC = 10: 1) daily and are visited for eight weeks
Main outcome variables
Change in hemoglobin A1C serum level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121021011192N10
Registration date:2021-02-23, 1399/12/05
Registration timing:registered_while_recruiting
Last update:2021-02-23, 1399/12/05
Update count:0
Registration date
2021-02-23, 1399/12/05
Registrant information
Name
Mohammad Abbasinazari
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
m_abbasi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of CBDEX 10 spray on the control of biochemical parameters(HbA1c, FBS, HOMA IR) in type 2 diabetes
Public title
The effect of CBDEX 10 in type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
En Type 2 diabetes based on ADA (American Diabetes Association) guideline
Age older than 18 years old
Exclusion criteria:
Uncontrolled seizure & untreated major depressive disorder
Pregnancy & lactation
eGFR less than 30 ml/min/1.73m2
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with Microsoft Excel software, block randomization.
for randomization of a list of names written from cell A2:A16 we will perform following order of functions:
1- the formula "RAND" will be written in cell B2 and will be copied to the end of the column:
RAND= ()
2- following formula will be written in C2 cell and randomized names from column A will be driven:
=INDEX($A$2:$A$16,RANK(B2,$B$2:$B$16),1)
3- above mentioned formula will be copied to as much number of cells as required.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants, principle investigator, healthcare providers (Physicians, nurses) who care for participants during the trial, data collectors and outcome assessors all are blinded by providing placebo spray in same size, shape color, odor and package with CBDEX10 spray which organized just by one responsible co-researcher has no involvement in running study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee School of Pharmacy and nursing and midwifery- shahid Beheshti university of medica
Street address
School of Pharmacy, Nyayesh junction, Valiasr street,Tehran
City
Tehran
Province
Tehran
Postal code
1985717413
Approval date
2021-01-05, 1399/10/16
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1399.302
Health conditions studied
1
Description of health condition studied
Diabet
ICD-10 code
E11.9
ICD-10 code description
Type 2 diabetes mellitus without complications
Primary outcomes
1
Description
Hemoglobin A1c (HbA1c) values
Timepoint
Before intervention and 60 days after initiation of daily use of spray
Method of measurement
Lab kits
Secondary outcomes
1
Description
Record of Adverse drug reactions
Timepoint
During intervention
Method of measurement
Interview with patients
Intervention groups
1
Description
Sublingual administration of 100 microgram from CBDEX 10 spray, twice daily (q12h) for 2 months along with the routine type 2 diabetes therapeutic regimen of the patient
Category
Treatment - Drugs
2
Description
Control group: Sublingual administration of 100 microgram from Placebo spray, twice daily (q12h) for 2 months along with the routine type 2 diabetes therapeutic regimen of the patient
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Educational and Research Hospital
Full name of responsible person
Mohammad Abasi Nazari
Street address
Shahid Madani street
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0231
Email
info@ehmc.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nima Naderi
Street address
School of Pharmacy, Nyayesh junction, Valiasr street
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8820 9625
Email
naderi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
25
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shima Afshar
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Nyayesh junction, Valiasr street, Tehran
City
Tehran
Province
Tehran
Postal code
00982188873704
Phone
+98 21 8820 9625
Email
afshar.shiima@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shima Afshar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Nyayesh junction, Valiasr street, Tehran
City
Tehran
Province
Tehran
Postal code
00982188873704
Phone
+98 21 8820 9625
Email
afshar.shiima@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shima Afshar
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Nyayesh junction, Valiasr street, Tehran
City
Tehran
Province
Tehran
Postal code
00982188873704
Phone
+98 21 8820 9625
Email
afshar.shiima@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available