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General information
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Recruitment centers
#1
Name of recruitment center - English: Diabetes Center of Kermanshah University of Medical Sciences
Name of recruitment center - Persian: مرکز دیابت دانشگاه علوم پزشکی کرمانشاه
Full name of responsible person - English: Dr Rozita Nasseri
Full name of responsible person - Persian: دکتر رزیتا ناصری
Street address - English: near Taleghani Hospital, Shaheed Beheshti Blv.
Street address - Persian: بلوار شهید بهشتی، جنب بیمارستان طالقانی
City - English: Kermanshah
City - Persian: کرمانشاه
Province: Kermanshah
Country: Iran (Islamic Republic of)
Postal code: 6715847167
Phone: +98 83 3836 2014
Fax:
Email: rnasseri.75@gmail.com
Web page address:
Name of recruitment center - English: Diabetes Center of Kermanshah University of Medical Sciences
Name of recruitment center - Persian: مرکز دیابت دانشگاه علوم پزشکی کرمانشاه
Full name of responsible person - English: Dr Rozita Nasseri
Full name of responsible person - Persian: دکتر رزیتا ناصری
Street address - English: Near Taleghani Hospital, Shaheed Beheshti Blvd.
Street address - Persian: بلوار شهید بهشتی، جنب بیمارستان طالقانی
City - English: Kermanshah
City - Persian: کرمانشاه
Province: Kermanshah
Country: Iran (Islamic Republic of)
Postal code: 6715847167
Phone: +98 83 3836 2014
Fax:
Email: rnasseri.75@gmail.com
Web page address:
Name of recruitment center - English: Diabetes Center of Kermanshah University of Medical Sciences Name of recruitment center - Persian: مرکز دیابت دانشگاه علوم پزشکی کرمانشاه Full name of responsible person - English: Dr Rozita Nasseri Full name of responsible person - Persian: دکتر رزیتا ناصری Street address - English: nearNear Taleghani Hospital, Shaheed Beheshti BlvBlvd. Street address - Persian: بلوار شهید بهشتی، جنب بیمارستان طالقانی City - English: Kermanshah City - Persian: کرمانشاه Province: Kermanshah Country: Iran (Islamic Republic of) Postal code: 6715847167 Phone: +98 83 3836 2014 Fax: Email: rnasseri.75@gmail.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr Farid Najafi
Full name of responsible person - Persian: دکتر فرید نجفی
Street address - English: Building No. 2, Shaheed Beheshti Blv., Kermanshah
Street address - Persian: بلوار شهید بهشتی، ساختمان شماره 2، دانشگاه علوم پزشکی کرمانشاه
City - English: Kermanshah
City - Persian: کرمانشاه
Province: Kermanshah
Country: Iran (Islamic Republic of)
Postal code: 6714673159
Phone: +98 83 3838 4185
Fax:
Email: farid_n32@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr Farid Najafi
Full name of responsible person - Persian: دکتر فرید نجفی
Street address - English: Building No. 2, Shaheed Beheshti Blvd
Street address - Persian: بلوار شهید بهشتی، ساختمان شماره 2، دانشگاه علوم پزشکی کرمانشاه
City - English: Kermanshah
City - Persian: کرمانشاه
Province: Kermanshah
Country: Iran (Islamic Republic of)
Postal code: 6714673159
Phone: +98 83 3838 4185
Fax:
Email: farid_n32@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr Farid Najafi Full name of responsible person - Persian: دکتر فرید نجفی Street address - English: Building No. 2, Shaheed Beheshti Blv., KermanshahBlvd Street address - Persian: بلوار شهید بهشتی، ساختمان شماره 2، دانشگاه علوم پزشکی کرمانشاه City - English: Kermanshah City - Persian: کرمانشاه Province: Kermanshah Country: Iran (Islamic Republic of) Postal code: 6714673159 Phone: +98 83 3838 4185 Fax: Email: farid_n32@yahoo.com Web page address:
Protocol summary
Study aim
Determination of clinical efficacy of olive leaf compared to pregabalin in reducing the amount of pain caused by diabetic neuropathy by to 50% of the initial amount
Design
The study is randomized, double-blinded without placebo control and in clinical trial stage 1-2
Settings and conduct
Selection of patients is done at the Diabetes Clinic affiliated to Kermanshah University of Medical Sciences. Patients participating in research and researcher completing questionnaires are Unaware of used medication.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Type I and II diabetic patients with diabetes for at least one year who have diabetic neuropathy pain;
History of neuropathic pain for at least three months;
The pain (VAS) is equal to or greater than 4;
Being at the age of 18 or over;
HbA1c is equal to or less than 11;
Non Inclusion criteria:
Pregnant and lactating women;
Patients who suffer from ischemic pain or other pain such as pain associated with amputation or arthritis; patients who have had Electroconvulsive Therapy in the past 30 days.
Intervention groups
Intervention group: the olive leaf extract three times a day for 3 months. Control group: pregabalin capsule, twice a day for three months.
Main outcome variables
Pain score on visual analog scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100513003922N4
Registration date:2019-01-08, 1397/10/18
Registration timing:registered_while_recruiting
Last update:2019-05-25, 1398/03/04
Update count:1
Registration date
2019-01-08, 1397/10/18
Registrant information
Name
Masoud Modarresi
Name of organization / entity
Faculty of Pharmacy - Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1835 6168
Email address
mmodarresi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of olive leaf extract and Pregabalin on symptomatic treatment of diabetic neuropathy
Public title
Study of effect of olive leaves on diabetic neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type I and II diabetic patients who have diabetes for at least one year and have diabetic neuropathy pain
History of neuropathic pain for at least three months
a pain score (VSA) equal to or greater than 4
at least 18 years of age or older
HbA1c is equal to or less than 11
Exclusion criteria:
Pregnant and lactating women
ischemic pain or other pain such as pains associated with amputation or arthritis
Electroconvulsive Therapy in the past 30 days
using warfarin, antiarrhythmic drugs, sedatives, hypnotices, anticonvulsants, NSAIDs and capsaicin in the past 7 days
using antipsychotics, antidepressants, opioids and muscle relaxants during the past 14 days
using anti-neuropathic drug and Unwillingness to stop taking it
Dependence on alcohol or other drugs
important metabolic diseases, cardiovascular diseases, thyroid disease, major blood diseases, reduced kidney function or liver function, bipolar disease, psychosis
history of suicide
drug sensitivity
Age
From 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two treatment groups based on the table of randomized numbers. A point is selected from the table of randomized numbers. From that point, the displacement will be done to the right and in the direction of the horizon. Odd numbers are assigned to the chemical treatment group and even numbers are assigned to the herbal treatment group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients participating in the study are unaware of the type of drug they receive (herbal or chemical). In addition, the researcher completing the questionnaire is also unaware of the type of drug that the patient has received.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No. 2, Shaheed Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Approval date
2018-11-14, 1397/08/23
Ethics committee reference number
IR.KUMS.REC.1397.581
Health conditions studied
1
Description of health condition studied
Diabetic neuropathy
ICD-10 code
E10.4
ICD-10 code description
Diabetic autonomic neuropathy
Primary outcomes
1
Description
Pain score on visual analog scale
Timepoint
At the end of each month for three consecutive months
Method of measurement
visual analog scale
Secondary outcomes
1
Description
quality of life score
Timepoint
At the beginning of the study and at the end of the third month of the study
Method of measurement
Quality of life questionnaire SF-36
2
Description
Diarrhea
Timepoint
during the study
Method of measurement
questionnaire of patient-reported side effects
3
Description
Stomach ache
Timepoint
during the study
Method of measurement
questionnaire of patient-reported side effects
Intervention groups
1
Description
Intervention group: Olive leaf extract (capsule) is given orally three times a day for three consecutive months.
Category
Treatment - Drugs
2
Description
Control group: Pregabalin is prescribed orally twice a day for three consecutive months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Center of Kermanshah University of Medical Sciences
Full name of responsible person
Dr Rozita Nasseri
Street address
Near Taleghani Hospital, Shaheed Beheshti Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
+98 83 3836 2014
Email
rnasseri.75@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Farid Najafi
Street address
Building No. 2, Shaheed Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Phone
+98 83 3838 4185
Email
farid_n32@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Masoud Modarresi
Position
Member of the scientific board of the university / Associate Professor (Ph.D.)
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Parastar Blv., Daneshgah St., Shaheed Shiroodi Blv.
City
Kermanshah
Province
Kermanshah
Postal code
6714415153
Phone
+98 83 3427 6482
Email
mmodarresi@kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Masoud Modarresi
Position
Member of the scientific board of the university/ Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Parastar Blv., Daneshgah St., Shaheed Shiroodi Blv.
City
Kermanshah
Province
Kermanshah
Postal code
6714415153
Phone
+98 83 3427 6482
Email
mmodarresi@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Masoud Modarresi
Position
Member of the scientific board of the university / Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Parastar Blv., Daneshgah St., Shaheed Shiroodi Blv.
City
Kermanshah
Province
Kermanshah
Postal code
6714415153
Phone
+98 83 3427 6482
Email
mmodarresi@kums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Pain scores and quality of life scores at the beginning and end of the study are shared.
When the data will become available and for how long
The access period starts 6 months after printing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Compliance with professional ethics in the use of data
From where data/document is obtainable
Send an email to the responsible person
What processes are involved for a request to access data/document
After reviewing the qualifications of the requesting person, the information is sent to researcher by email at most three months.