Effect of Ziziphus jujube fruit on glycemic control and lipid profiles in people with type2 diabetes :A randomized double blinded placebo-controlled clinical trial
Determining the effectiveness of Ziziphus jujube on the improvement glycemic control and lipid profiles in people with type 2 diabetes in patients who refer to the diabetes clinic of Allameh Behlool Gonabadi Hospital.
Design
A parallel randomized double blind clinical trial with intervention and placebo group
Settings and conduct
This study will be done in Allameh Behlool Gonabadi Hospital diabetes clinic. 120 type 2 diabetes patients with inclusion criteria will be assigned to intervention and placebo group. The randomization method is block randomization. In this study patients and researchers will be blinded
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 30-70, Patients who are diagnosed as Type 2 diabetes, Having type 2 diabetes for less than 10 years, Have a glycosylated hemoglobin (A1C) level of less than 10% Have an LDL or TG or T-Chol level above the normal range or HDL below the normal range, Informed consent able to be obtaine. Exclusion Criteria: consumption of ziziphus jujube or other herbal medicines during the last 4 weeks before the start of the study, taking anticoagulant medication, history of addiction, pregnancy and lactation.
Intervention groups
Intervention Group: Patients with type 2 diabetes that will be Recipient of standard drugs + Ziziphus jujube 40 gram daily Control Group: Patients with type 2 diabetes that will be Recipient of standard drugs + placebo
Main outcome variables
Fasting blood sugar (FBS), glycosylated hemoglobin (A1C),Total Cholesterol (Chol-T), Triglyceride (TG), Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200418047116N2
Registration date:2020-11-18, 1399/08/28
Registration timing:prospective
Last update:2020-11-18, 1399/08/28
Update count:0
Registration date
2020-11-18, 1399/08/28
Registrant information
Name
Negar Shafaei bajestani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5723 6833
Email address
shafaei.n@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Ziziphus jujube fruit on glycemic control and lipid profiles in people with type2 diabetes :A randomized double blinded placebo-controlled clinical trial
Public title
The effect of Ziziphus jujube fruit on blood sugar control and lipid profiles in people with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being between 30 and 70 years old
Having a confirmed diagnosis of type 2 diabetes according to the American Diabetes Association
Having type 2 diabetes for less than 10 years
Have a glycosylated hemoglobin (A1C) level of less than 10% Have an LDL or TG or T-Chol level above the normal range or HDL below the normal range
Having a glucometer to measure fasting blood sugar
No history of allergy to ziziphus jujube fruit consumption (according to self-report)
Lack of liver problems, kidney failure and cancer
No consumption of ziziphus jujube or other herbal medicines during the last 4 weeks before the start of the study
No history of addiction
Non-pregnancy and lactation for women
Lack of experience of acute and severe stress during the last 2 weeks before the start of the study
No gastrointestinal symptoms after milk consumption (lactose intolerance)
Having informed consent to participate in the research
Exclusion criteria:
Existence of addiction
Coagulation disorders or the use of anticoagulants
Consumption of other herbal medicines that affect the results of the study and its validity
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method is block randomization and block size of 4. Randomization sequence and concealment codes will de created by www.sealedenvelope.com website.
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo will be produced in a sachet with same color that Ziziphus jujube sachet is. Participants, care provider, investigator and outcome assessor are kept blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Gonabad University of Medical Science
Street address
Gonabad - Asian Roadside - Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2020-10-20, 1399/07/29
Ethics committee reference number
IR.GMU.REC.1399.088
Health conditions studied
1
Description of health condition studied
type2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Fasting blood sugar (FBS)
Timepoint
before intervention and three months after intervention
Method of measurement
laboratory instruments
2
Description
low density lipoprotein (LDL)
Timepoint
before intervention and three months after intervention
Method of measurement
laboratory instruments
3
Description
Glycosylated hemoglobin (A1C)
Timepoint
before intervention and three months after intervention
Method of measurement
laboratory instruments
4
Description
high density lipoprotein (HDL)
Timepoint
before intervention and three months after intervention
Method of measurement
laboratory instruments
5
Description
total cholesterol (chol-T)
Timepoint
before intervention and three months after intervention
Method of measurement
laboratory instruments
6
Description
triglyceride (TG)
Timepoint
before intervention and three months after intervention
Method of measurement
laboratory instruments
Secondary outcomes
1
Description
BMI
Timepoint
before intervention and three months after intervention
Method of measurement
Measurement of weight and height
Intervention groups
1
Description
Intervention group: Standard Drugs + Ziziphus jujube fruit powder 20 g two times a day for three months.
Category
Treatment - Drugs
2
Description
Control group: Standard Drugs + placebo (in terms of sachet color similar to Ziziphus jujube sachet ) two times a day for three months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Clinic of Allameh Behlool Hospital
Full name of responsible person
Negar Shafaei Bajestani
Street address
Nurse St., Diabetes Clinic of Allameh Behlool Hospital, Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5723 6833
Email
shafaei.n@gmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Shahla Khosravan
Street address
Dr.Mehdizade Blvd.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
info@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Negar Shafaei Bajestani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Allameh Bohlool Gonabadi Hospital, Vahdat Blvd.,Saadi St.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691797852
Phone
+98 51 5723 6833
Email
Shafaei.n@gmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Negar Shafaei Bajestani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Allameh Bohlool Gonabadi Hospital, Vahdat Blvd.,Saadi St.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691797852
Phone
+98 51 5723 6833
Email
shafaei.n@gmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Negar Shafaei Bajestani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Allameh Bohlool Gonabadi Hospital, Vahdat Blvd.,Saadi St.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691797852
Phone
+98 51 5723 6833
Email
shafaei.n@gmu.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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be shared after patients are made unidentifiable.
When the data will become available and for how long
Data can be accessible 6 months after results are published.
To whom data/document is available
The researchers in university and other scientific institutes.
Under which criteria data/document could be used
Help in managing of patients.
From where data/document is obtainable
Data can be accessible through sending an email to the corresponding author.
What processes are involved for a request to access data/document
After sending a request email to the corresponding author, data will be sent in 1 month.