If the clinical and laboratory results are confirmed, the glucoside natural product can be used as a herbal medicine
be introduced for the therapeutic use of patients.
Design
A clinical trial with a control group, with cross-over groups, three blind strains, randomized, phase 2 for 100 patients, random numbers of even and odd numbers have been used for randomization.
Settings and conduct
The place of the project is Shahid Faeq Social Security Clinic. Random blinding is based on even and odd numbers. All people except the attending physician are blinded in this plan
Participants/Inclusion and exclusion criteria
Hyperglycemia
Intervention groups
100 patients with type 2 diabetes are randomly divided into two groups (odd and even numbers). The first group includes: the case group that receives the usual medicine along with the glucoside plant compound daily for 3 months under the supervision of the attending physician. The second group: the control group includes patients who receive the usual medicine along with a placebo with the same conditions
Investigating the effect of natural glucoside product on glycemia of patients with type 2 diabetes, lipidemia and fatty liver disease.
Public title
Investigating the effect of natural glucoside product on glycemia of patients with type 2 diabetes, lipidemia and fatty liver disease.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hyperglycemia
Hyperlipidemia
Exclusion criteria:
History of allergy to drug compounds
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients with type 2 diabetes are randomly divided into two groups (odd and even numbers). The first group includes: the case group that receives the usual medicine along with the glucoside plant compound daily for 3 months under the supervision of the attending physician. The second group: the control group includes patients who receive the usual medicine along with a placebo with the same conditions. Specific codes will be determined for all patients, and except for the treating physician, the plan implementers will be unaware of it. At the end of the design of the codes, the doctor will provide them to the statistical analyzer and statistical analysis will be done.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad Azad University of Medical Sciences
Street address
No14, Emam khomeini Ave, Mashhad Town.
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Approval date
2024-07-10, 1403/04/20
Ethics committee reference number
IR.IAM.MSHD.REC.1403.25
Health conditions studied
1
Description of health condition studied
Hyperglycemia
ICD-10 code
R73.9
ICD-10 code description
Hyperglycemia, unspecified
2
Description of health condition studied
Hyperlipidemia
ICD-10 code
E78.5
ICD-10 code description
Hyperlipidemia, unspecified
Primary outcomes
1
Description
Age
Timepoint
Before the intervention
Method of measurement
Age number
2
Description
Sex
Timepoint
Before intervention
Method of measurement
Ratio
3
Description
BMI
Timepoint
Before the start of the intervention and 90 days after the start of the drug
Method of measurement
Numerical formula
4
Description
HbA1c
Timepoint
Before the start of the intervention and 90 days after the start of the drug
Method of measurement
Blood test
5
Description
Fasting blood suger
Timepoint
Before the start of the intervention and 90 days after the start of the drug.
Method of measurement
Blood test.
6
Description
Two hours post prandial glucose.
Timepoint
Before the start of the intervention and 90 days after the start of the drug
Method of measurement
Blood test
7
Description
Blood sodium
Timepoint
Before the start of the intervention and 90 days after the start of the drug
Method of measurement
Sodium Blood test
8
Description
Blood Potassium.
Timepoint
Before the start of the intervention and 90 days after the start of the drug
Method of measurement
Potassium Blood test
9
Description
Blood urea
Timepoint
Before the start of the intervention and 90 days after the start of the drug
Method of measurement
Blood urea test
10
Description
Serum creatinine
Timepoint
Before the start of the intervention and 90 days after the start of the drug
Method of measurement
Blood test
11
Description
Analyze urine
Timepoint
Before the start of the intervention and 90 days after the start of the drug
Method of measurement
Urinalysis
12
Description
Cytotoxicity assay
Timepoint
Before the start of the intervention and 90 days after the start of the drug
Method of measurement
Blood Test
13
Description
Lipid profile
Timepoint
Before the start of the intervention and 90 days after the start of the drug
Method of measurement
Lipid profile Blood Test.
14
Description
Liver function tests.
Timepoint
Before the start of the intervention and 90 days after the start of the drug
Method of measurement
Blood Test.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: They receive the usual medicine along with 500mg glucoside plant compound daily for 3 months under the supervision of a treating physician.
Category
Treatment - Drugs
2
Description
Control group: Patients receiving the usual drug plus a placebo for 3 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bilal Habashi Social Security Clinic
Full name of responsible person
Seyyed Mohammad Reza Hashemizadeh
Street address
Resalat Blvd., Bilal Quay, Mashhad Town.
City
Mashhad
Province
Razavi Khorasan
Postal code
9185914711
Phone
+98 51 3762 7910
Email
dr.hashemizadeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr.Touraj Zandbaf
Street address
No.14 , Emam khomein Ave., Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9193798666
Phone
+98 51 3225 0041
Email
IMRC@mshdiau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Bo Ali Research Institute of Saleh Daru Novin Mashhad Company.
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyyed Mohammad Reza Hashemizadeh
Position
A doctor specializing in traditional medicine
Latest degree
Specialist
Other areas of specialty/work
Traditional Medicine
Street address
No.9, 21 Ibn Sina Ave; Senabad St; Mashhad Town.
City
Mashhad
Province
Razavi Khorasan
Postal code
9183664555
Phone
+98 51 3845 3742
Email
Dr.hashemizadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyyed Mohammad Reza Hashemizadeh
Position
A doctor specializing in traditional medicine
Latest degree
Specialist
Other areas of specialty/work
Traditional Medicine
Street address
21 Ibn Sina St., Senabad Street, Mashhad Town.
City
Mashhad
Province
Razavi Khorasan
Postal code
9183664555
Phone
+98 915 109 8452
Email
Dr.hashemizadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fateme Mollazade
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Education
Street address
No. 8, Alaleh Ave, Pirouzi Blvd, Mashhad Town.
City
Mashhad
Province
Razavi Khorasan
Postal code
9193798666
Phone
+98 51 5523 4944
Fax
Email
F.mollazade1159@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Part of the information that is useful will be published for the use of others.
When the data will become available and for how long
Access starts one year after results are published
To whom data/document is available
Researchers and people working in the industry.
Under which criteria data/document could be used
It is allowed to use the results of the study for the benefit of the patients
From where data/document is obtainable
Dr. Hashemizadeh to the following email address:
drhashemizadeh@gmail.com
What processes are involved for a request to access data/document