Preparation and evaluation of anti-diabetic effects of palm kernel powder pellets in reducing blood sugar in type 2 diabetic patients
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 140 patients. We use a simple randomization model using a table of random numbers (computer randomization method).
Settings and conduct
This study is a double-blind clinical trial study that will be performed on type 2 diabetic patients referred to the diabetes clinic. 140 patients will be randomly divided into intervention and control groups (70 people in each group). In addition to metformin, the patient will receive the drug (date kernel plate or placebo) in sealed packets that are encoded. Coded by one of the design partners and the doctor, the evaluator, and the patient are blind
Participants/Inclusion and exclusion criteria
Inclusion criteria for patients aged 30 to 60 years with type 2 diabetes and At least 6 months have passed since the diagnosis of diabetes
Exclusion criteria:
1. During the study, he gets another disease and receives another medicine
2. Getting pregnant while studying
3. Lack of adherence to the treatment protocol
4. Change in patients' medication regimen
Intervention groups
Intervention group: 70 patients in adition to metformin 500 mg tablets (one every 12 hours), palm kernel plate, are given one 200 mg capsule every 12 hours for 90 days and fasting blood sugar, 2-hour blood sugar daily and also in The end of the study HbA1C is analyzed
control group: 70 patients in adition to metformin 500 mg tablets (one every 12 hours), placebo, are given one 200 mg capsule every 12 hours for 90 days and fasting blood sugar, 2-hour blood sugar daily and also in The end of the study HbA1C is analyzed
Preparation and comparison of anti-diabetic effects of palm kernel powder plates with placebo in diabetic patients treated with metformin
Public title
Anti-diabetic Herbal Drug
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having type 2 diabetes
Less than 6 months have passed since the onset of the disease
Fasting blood sugar is less than 200 and HbA1C is less than 9
Age 30-60 years
Exclusion criteria:
Pregnant or lactating patient
Age under 30 or over 60 years
Advanced complications of diabetes
Patients undergoing chemotherapy
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are placed in two intervention or control groups using allocation Random Software (RAS) through a four- and six-block block with a 1: 1 allocation ratio. Consume one every 12 hours for 90 days.Random allocation sequences will be generated by the non-researcher, cans will be numbered from 1 to 140. Both groups will receive routine metformin treatment.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient receives the drug (date kernel plate or placebo) in sealed envelopes. The coding is done by one of the project partners and the doctor, the evaluator and the patient are blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Science
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2021-06-26, 1400/04/05
Ethics committee reference number
IR.AJUMS.REC.1400.233
Health conditions studied
1
Description of health condition studied
Diabetes type2
ICD-10 code
Z79.84
ICD-10 code description
oral antidiabetic drugs
Primary outcomes
1
Description
Fasting blood sugar, HbA1C ,2-hour blood sugar
Timepoint
Measurement of fasting blood sugar, HbA1C .Blood sugar 2 hours at the beginning of the study and after 3 months
Method of measurement
Blood glucose measuring device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 70 patients in adition to metformin 500 mg tablets (one every 12 hours), palm kernel plate, are given one 200 mg capsule every 12 hours for 90 days
Category
Treatment - Drugs
2
Description
control group: 70 patients in adition to metformin 500 mg tablets (one every 12 hours), placebo are given one capsule 200 mg every 12 hours for 90 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Amanollah Zarei Ahmady
Street address
24 meter street of Imam Khomeini Hospital, endocrinology clinic
City
ahwaz
Province
Khouzestan
Postal code
6185676789
Phone
+98 61 3222 2816
Email
amanzarei@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mehdi Ahmadi Moghadam
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 1111
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra Farhangian
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 5940
Email
zarei-a@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Neda Mohtasham
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3311 5940
Email
mohtaham-n@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Amanollah Zarei Ahmady
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 5940
Email
zarei-a@ajums.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