Comparison of the glucoherb efficacy with metformin on glycemic indices and glycosylated hemoglobin in prediabetes patients referring to Imam Ali Diabetic Center
Design
This study is a double blind clinical trial phase 3. 72 patients were randomly assigned to two intervention groups. Intervention group 1: Metformin tablets orally 500 mg daily and Intervention group 2: Glucoherb tablets (herbal medicine of Barij essence). After four months, patients' blood glucose levels are checked again
Settings and conduct
72 Patients studied in the diabetes center of Shahrekord.For blinding, drugs are taken out from their main boxes and put in boxes without name that has written just letters A or B and they are the name of groups and drugs are given to the patients by one of the nurses in terms of the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: not consuming anti-diabetes and insulin medications, corticosteroids, and multivitamins, not being pregnant or breast-feeding, cooperating in the study, and having prediabetes symptoms. Exclusion criteria: not continue the study
Intervention groups
Intervention group 1: Metformin tablets taken orally 500 mg daily
Intervention group 2: Oral glucohydrate tablets (herbal medicine of Barij essence).
Main outcome variables
Blood suger level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190125042486N2
Registration date:2019-10-19, 1398/07/27
Registration timing:retrospective
Last update:2019-10-19, 1398/07/27
Update count:0
Registration date
2019-10-19, 1398/07/27
Registrant information
Name
Abolghasem sharifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3333 0061
Email address
gh_sh_fr51@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-06-21, 1396/03/31
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
2017-06-30, 1396/04/09
Actual recruitment end date
2018-12-21, 1397/09/30
Trial completion date
2019-02-28, 1397/12/09
Scientific title
The effect of glucoherb and metformin on glycemic indixes in prediabetics patients
Public title
The effect of glucoherb and metformin on glycemic indixes in prediabetics patients
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
They do not consume tobacco.
They do not consume alcohol.
Patients who do not take anti-diabetes and insulin medications.
Patients who are not pregnant or breast-feeding.
In the recent 3 months, multivitamin, antioxide and Omega 3 have not received.
Patients who have not kidney, liver, thyroid and parathyroid, gastrointestinal and heart disease and cancer.
Medicines like corticosteroids that have an effect on blood glucose are not consumed
They would like to participate in the project.
Patients who are recognized with prediabetes symptoms.
Exclusion criteria:
Patients cancel continuing the study.
Age
From 1 day old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
72
Actual sample size reached:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling was random allocation, which patients randomly selected as B or A envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Double blinding included the investigator and patients. For not having aware of patients, medications were taken out from the package and placed in cans written with letters A or B. For not having aware of investigator, the medications were administered or injected to the patients by nurses.
Placebo
Not used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Shahrekord University of Medical Sciences
Street address
Kashani street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814646885
Approval date
2019-03-04, 1397/12/13
Ethics committee reference number
IR.SKUMS.REC.1397.266
Health conditions studied
1
Description of health condition studied
diabetes mellitus
ICD-10 code
E10-E14
ICD-10 code description
With other specified complications
Primary outcomes
1
Description
glycemic indixes
Timepoint
at the end of 12th week
Method of measurement
The checklist contained the name and characteristics of the patients together with the treatment group. Checklists of FBS, BS2PP, HBA1C
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1:take metformin tablets orally 500 mg orally
Category
Treatment - Drugs
2
Description
Intervention group 2: take Glucherb tablets (herbal medicine of Barij essence)
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Diabetic Center
Full name of responsible person
Rahil Riyahi
Street address
Parastar Avenue
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814646885
Phone
+98 38 3333 0061
Email
riahi.r@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Kamal Solati
Street address
Kashani street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814646885
Phone
+98 38 3333 0061
Email
solati_k@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Iman Izadi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Rahmatieh
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814646885
Phone
+98 38 3333 0061
Fax
Email
iman89110@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Rahil Reyahi
Position
Assistant professor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
parastar Avenue
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814646885
Phone
+98 38 3333 0061
Email
riyahi.r@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Abolghasem Sharifi
Position
in employment
Latest degree
Master
Other areas of specialty/work
Social Services
Street address
kashani Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814646885
Phone
+98 38 3333 0061
Email
gh_sh_fr51@yahoo.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
No - There is not 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
Title : The comparison of glucoherb efficacy with metformin on glycemic indices and glycosylated hemoglobin in prediabetes diseases referring to imam ali diabetic center
When the data will become available and for how long
2019
To whom data/document is available
Rahil Reyahi
Under which criteria data/document could be used
ethics Committee
From where data/document is obtainable
Deputy of Research and Technology
What processes are involved for a request to access data/document