Protocol summary
-
Study aim
-
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 composition six times a day for 3 months under the supervision of the attending physician. The second group: the control group includes patients who receive the usual drug along with a placebo with the same conditions
-
Main outcome variables
-
Diabetes; Age; sex; BMI; HbA1c; FBS; BS.2h; urea; Serum creatinine; UA; Mtt cytotoxicity assay; Lipid profile; Liver function tests.
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20231030059908N4
Registration date:
2024-08-15, 1403/05/25
Registration timing:
registered_while_recruiting
Last update:
2024-08-21, 1403/05/31
Update count:
1
-
Registration date
-
2024-08-15, 1403/05/25
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2024-08-15, 1403/05/25
-
Expected recruitment end date
-
2024-11-15, 1403/08/25
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
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
-
Ethics committees
1
-
Ethics committee
-
-
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 urea
-
Timepoint
-
Before the start of the intervention and 90 days after the start of the drug
-
Method of measurement
-
Blood urea test
8
-
Description
-
Serum creatinine
-
Timepoint
-
Before the start of the intervention and 90 days after the start of the drug
-
Method of measurement
-
Blood test
9
-
Description
-
Analyze urine
-
Timepoint
-
Before the start of the intervention and 90 days after the start of the drug
-
Method of measurement
-
Urinalysis
10
-
Description
-
Cytotoxicity assay
-
Timepoint
-
Before the start of the intervention and 90 days after the start of the drug
-
Method of measurement
-
Blood Test
11
-
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.
12
-
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.
Intervention groups
1
-
Description
-
Intervention group: they will receive the usual medicine along with 500mg glucoside herbal combination six times a day 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
1
-
Sponsor
-
-
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
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
-
Send request to the mentioned email.
-
Comments
-