Evaluation of the effect of traditional Persian diabetes product (Tabashir tablet) on blood glucose level in patients with type 2 diabetes: a double-blind placebo-controlled clinical trial
Determining the effectiveness of the traditional medicinal product, diabetes pills (Qoras Tabashir), in comparison with standard treatment in controlling blood sugar in patients with type 2 diabetes.
Design
A double-blind randomized clinical trial
Settings and conduct
This study is conducted in the Diabetes Clinic of the Endocrine and Metabolism Center of Tehran University of Medical Sciences. The doctor and the patient do not know whether the prescribed product is a drug or a placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1. Age: thirty to sixty-five years
2. Uncontrolled type 2 diabetes
3. The amount of HbA1c is more than seven and less than eight and a half
4. At least one month has passed since adding the dose of anti-diabetic medicine or prescribing a new anti-diabetic medicine
Exclusion criteria:
1- Glomerular filtration rate, less than 60 ml/min
2- Serum albumin, less than 4 grams per deciliter
3- High SGOT and SGPT more than three times the normal level
4- Pregnancy and breastfeeding or intention to become pregnant
5- Taking insulin along with oral diabetes medications
Intervention groups
Intervention group: In addition to the standard treatment of diabetes, one Tabashir capsule (500 mg) three times a day. Control group: In addition to the standard treatment, a placebo of the same weight and with an indistinguishable appearance, one capsule three times a day
Main outcome variables
Two-hour blood glucose and fasting blood glucose levels and HbA1c levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230307057648N1
Registration date:2024-01-08, 1402/10/18
Registration timing:prospective
Last update:2024-01-08, 1402/10/18
Update count:0
Registration date
2024-01-08, 1402/10/18
Registrant information
Name
Mahbubeh Bozorgi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5521 4060
Email address
mahboubehbozorgi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2025-02-19, 1403/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of traditional Persian diabetes product (Tabashir tablet) on blood glucose level in patients with type 2 diabetes: a double-blind placebo-controlled clinical trial
Public title
Effect of Tabashir tablet in treatment of diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Uncontrolled type 2 diabetes
Age 30-65 years
HbA1c greater than 7 and lower than 8.5
Under treatment with oral diabetes medications (one or more drug groups)
At least one month after increasing the dose of antidiabetic medicine or prescribing a new antidiabetic medicine
Exclusion criteria:
Glomerular filtration rate, lower than 60 ml per minute
Serum albumin, lower than 4 g/dL
SGOT and SGPT, three times higher than normal level
Pregnancy and breastfeeding or intention to become pregnant
Taking insulin along with oral diabetes medications
Age
From 30 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
106
Randomization (investigator's opinion)
Randomized
Randomization description
Diabetic patients are randomly divided into two groups "control, intervention" after examination and if they meet the criteria to enter the trial. The random block method with blocks of four will be used by using online websites for random allocation. A numerical code is defined for the random sequence, and people receive the numerical code in the same order as they enter and are placed in the corresponding group according to the block
Blinding (investigator's opinion)
Double blinded
Blinding description
Medicine and placebo are prepared with a completely similar appearance. The patient enters the plan with his consent and receiving full explanations, but he does not know whether he has received a drug or a placebo, and the doctor is not aware of whether the product he is giving to the patient 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 Research Institute of Endocrine and Metabolism, Tehran university of medical sci
Street address
َTehran, Persian Gulf Highway (Tehran-Qom), Shahed University
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2022-06-15, 1401/03/25
Ethics committee reference number
IR.TUMS.EMRI.REC.1401.008
Health conditions studied
1
Description of health condition studied
diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
blood sugar
Timepoint
Blood sugar measurement at the beginning of the study (before the start of the intervention) and three months after taking the Tabashir capsule
Method of measurement
Blood test
Secondary outcomes
1
Description
Lipid profile
Timepoint
At the beginning and end of three months of study
Method of measurement
Blood test
Intervention groups
1
Description
Intervention group: One 500 mg Tabashir capsule three times a day. . Formulation (in w/w) Tabashir powder 13.2, licorice root solid extract 13.2, lettuce seed 26.5, purslane seed 20, Armenian bole 2.6, rose bud powder without sepals 6.6, Coriander leaf and stem powder 6.6, acacia extract powder 2.6, gum arabic powder 2.6, white sandal solid powder 2.6, gelnar solid powder 2.6, camphor solid powder 0.6
Category
Treatment - Drugs
2
Description
Control group: Receiving 500 mg placebo capsules containing starch
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Superspecialized Diabetes Clinic
Full name of responsible person
Mahbubeh Bozorgi
Street address
No. 4, Ostad Nejatollahi St., Tehran - Elkhebal St.
City
Tehran
Province
Tehran
Postal code
1411713139
Phone
+98 21 8880 8005
Email
mahboubehbozorgi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ms. Salimi
Street address
Endocrine and Metabolism Research Institute, next to Dr. Shariati Hospital, Jalal Al Ahmad Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1411713139
Phone
+98 21 8863 1298
Email
emrc@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Valiasr traditional medicine clinic (Dr.kordafshar clinic)
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Mahbubeh Bozorgi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Khalij Fars Expressway, Shahed university
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5521 4060
Fax
Email
mahboubehbozorgi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Mahbubeh Bozorgi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Khalij Fars Expressway, Shahed university
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5521 4060
Fax
Email
mahboubehbozorgi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Mahbubeh Bozorgi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Khalij Fars Expressway, Shahed university
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5521 4060
Fax
Email
mahboubehbozorgi@gmail.com
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
Confidentiality principles will be observed in publishing patient information. The method and results section will be mentioned in full in the article that will be written from this research.
When the data will become available and for how long
Information will be available from the time the article is published.
To whom data/document is available
Method information and results are mentioned in the article and will be available to the public
Under which criteria data/document could be used
The information that is not published in the article will be provided to other researchers, if necessary, while maintaining privacy and confidentiality
From where data/document is obtainable
The information published in the article will be available to the public. To obtain other documents, you should contact the project manager.
What processes are involved for a request to access data/document
Contact with the project manager is done via email. Then, the request is reviewed by the project manager and, if necessary, by the ethics committee, so that if there is no ethical problem, it is possible to access the documents.