To assess the effect of herbal formulation versus placebo in diabetic patients
Design
This is a triple-blind randomized clinical trial, phase II, in which 58 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible diabetic patients who will refer to Shahid Beheshti Hospital during the study period will be enrolled in the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 30 to 60 years;
Type 2 diabetes;
Hemoglobin A1c above 7%
Exclusion criteria:
Renal disorder;
Liver disorder;
Gastric disorder;
Cardiovascular diseases
Intervention groups
Intervention group: Routine treatment of diabetes plus herbal formulation capsule 100 mg daily for 3 months
Control group: Routine treatment of diabetes plus placebo capsule daily for 3 months
The patients will be randomly assigned to intervention and control groups using block randomization
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions Therefore, the trial will be run as triple blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2018-07-21, 1397/04/30
Ethics committee reference number
IR.UMSHA.REC.1397.299
Health conditions studied
1
Description of health condition studied
Diabetes mellitus
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Measuring fasting blood sugar
Timepoint
Before intervention and 3 and 6 months after intervention
Method of measurement
By laboratory test
2
Description
Measuring blood sugar
Timepoint
Before intervention and 3 and 6 months after intervention
Method of measurement
By laboratory test
3
Description
Measuring hemoglobin A1c
Timepoint
Before intervention and 3 and 6 months after intervention
Method of measurement
By laboratory test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine treatment of diabetes plus herbal formulation capsule 100 mg daily for 3 months
Category
Treatment - Drugs
2
Description
Control group: Routine treatment of diabetes plus placebo capsule daily for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Mohammad Amin Shakeri Rad
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
shakeri.amin.kourosh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Amin Shakeri Rad
Position
Pharmacology Student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
shakeri.amin.kourosh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Dara Dastan
Position
Pharmacologist
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
d.dastan@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available