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Effect of Zataria-Multiflora in glycemeic control in diabetic patients

Protocol summary

Study aim
Achieving fasting blood sugar is 70-130 mg/dl and BS ≤ 160 mg/dl.
Design
The study is a double blind prospective clinical trial. The number of 128 patients (150 patients including 20% dropout) were randomly divided into two groups of 64 people.
Settings and conduct
The clinical trial is conducted in the clinic of Shahid Labafinejad Hospital and on type 2 diabetic patients.. On the first day of the study and before the start of the first dose of the drug, fasting blood samples were taken from the patients and the investigated items included FBS, BS, HbA1c, LDL, HDL, Chol, TG, AST, ALT, weight, blood pressure and abdominal circumference of patients are recorded. Also, after 30, 60 and 90 days from the start of the study, these items are re-evaluated. The medicine and placebo are delivered to the nurse in similar packages and the nurse provides them to the patients without knowing the contents of the package, the nurse and the patients will not know about the contents of the package.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients over 18 years old. Having type 2 diabetes. Take oral medicine. HbA1C is more than 7 and less than 10 Exclusion criteria: Patients below 18 years old. Dissatisfaction. Insulin consuming. HbA1C is less than 7 and more than 10
Intervention groups
After obtaining informed consent, the patients were randomly divided into two groups and one group was treated with placebo and the other group was treated with thyme capsules. Patients take 3 placebo capsules or three thyme capsules daily for up to 3 months along with their other medications.
Main outcome variables
FBS(Fast blood sugar),HbA1C

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160412027346N9
Registration date: 2022-11-11, 1401/08/20
Registration timing: prospective

Last update: 2022-11-11, 1401/08/20
Update count: 0
Registration date
2022-11-11, 1401/08/20
Registrant information
Name
Shadi Ziaie
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
shadiziaie@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-06, 1401/09/15
Expected recruitment end date
2023-03-06, 1401/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Zataria-Multiflora in glycemeic control in diabetic patients
Public title
Effect of Zataria-Multiflora in Diabet
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years old Having type 2 diabetes Take oral medicine HbA1C is more than 7 and less than 10
Exclusion criteria:
Patients below 18 years old Dissatisfaction Insulin consuming HbA1C is less than 7 and more than 10
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Data analyser
Sample size
Target sample size: 128
Randomization (investigator's opinion)
Randomized
Randomization description
Using the simple randomization method and according to the table of random numbers, the patients were divided into two groups, A and B, and one group was given medicine and the other group was given placebo, which were completely similar in terms of shape and packaging. Only the principal investigator will know the code of the drugs. Medicines are given to patients by ward nurses who do not know the code of medicines.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drug and the placebo are in a package with a standard label and the same amount, and each box is assigned a code that is only available to the researcher, depending on whether it is a drug or a placebo.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Tehran Province, Tehran, Velenjak, Arabi Ave
City
Tehran
Province
Tehran
Postal code
19839-63113
Approval date
2022-03-15, 1400/12/24
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1401.010

Health conditions studied

1

Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
Fast blood sugar
Timepoint
At the beginning of the study, 30, 60 and 90 days later
Method of measurement
Measuring fasting blood sugar with glucose oxidase enzymatic method

Secondary outcomes

1

Description
The effect of Zataria-Multiflora extract on ّHbA1C
Timepoint
At the beginning of the study, 30, 60 and 90 days later
Method of measurement
HbA1C Laboratory test by HPLC

Intervention groups

1

Description
Intervention group: We put 0.5 grams of Zataria-Multiflora extract, Prepared by Extraction Center of Jihad Agricultural Research Complex, in a size 00 capsule. In this treatment method, which is taken orally and at 8-hour intervals, each patient is given a pack of 90 capsules for 1 month and daily consumption of three capsules (1/5 gram of thyme extract) to be taken orally along with other medicines, and for the second and third months, a package of 90 pieces will be delivered to the patient at the appointed time and after each test, after 30 and 60 days. we give.
Category
Treatment - Drugs

2

Description
We put starch in 00 size capsules, Placebo capsules were made in the pharmaceutics laboratory of Shahid Beheshti University of Medical Sciences, Faculty of Pharmacy. in this treatment method which is taken orally and at 8-hour intervals, we deliver to each patient a package of 90 capsules for 1 month and daily consumption of three capsules so that along with other take drugs orally, and for the second and third months, we deliver a 90-count package to the patient at the appointed time and after each test, after 30 and 60 days.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Labbafinejad Medical center
Full name of responsible person
Dr Shadi Ziaie
Street address
9th Boostan Pasdaran St Tehran
City
Tehran
Province
Tehran
Postal code
5546859685
Phone
+98 21 23601
Email
Shadiziaie@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Nima Naderi
Street address
Niayesh Highway, Valiasr Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8820 0118
Email
school.pharmacy@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
100
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
Dr Shadi Ziaie
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
9th Boostan, Pasdaran Street
City
Tehran
Province
Tehran
Postal code
2356987452
Phone
+98 23602188021
Email
shadiziaie@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Shadi Ziaie
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
9th Boostan, Pasdaran Street
City
Tehran
Province
Tehran
Postal code
2356987452
Phone
+98 23602188021
Email
shadiziaie@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Shadi Ziaie
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
9th Boostan, Pasdaran Street
City
Tehran
Province
Tehran
Postal code
2356987452
Phone
+98 23602188021
Email
shadiziaie@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
At the end of the study all the data after blinding and statistical analysis based on what mentioned in methodology will be extracted and published online as a scientific paper
When the data will become available and for how long
6 months after publishing the results
To whom data/document is available
responsible investigator, Physicians, academician investigators
Under which criteria data/document could be used
only with permission of responsible investigator or regulatories
From where data/document is obtainable
Responsible investigator
What processes are involved for a request to access data/document
Through contacting with responsible investigator(Dr.Shadi ziaie Ardestani) Shadiziaie@sbmu.ac.ir
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