Protocol summary
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Study aim
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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
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Design
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The study is randomized, double-blinded without placebo control and in clinical trial stage 1-2
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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Intervention group: the olive leaf extract three times a day for 3 months. Control group: pregabalin capsule, twice a day for three months.
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Main outcome variables
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Pain score on visual analog scale
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2019-01-08, 1397/10/18
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-12-22, 1397/10/01
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Expected recruitment end date
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2019-09-22, 1398/06/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparing the effectiveness of olive leaf extract and Pregabalin on symptomatic treatment of diabetic neuropathy
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Public title
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Study of effect of olive leaves on diabetic neuropathy
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old
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Gender
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Both
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Phase
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1-2
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Groups that have been masked
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Sample size
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Target sample size:
66
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-11-14, 1397/08/23
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Ethics committee reference number
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IR.KUMS.REC.1397.581
Health conditions studied
1
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Description of health condition studied
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Diabetic neuropathy
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ICD-10 code
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E10.4
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ICD-10 code description
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Diabetic autonomic neuropathy
Primary outcomes
1
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Description
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Pain score on visual analog scale
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Timepoint
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At the end of each month for three consecutive months
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Method of measurement
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visual analog scale
Secondary outcomes
1
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Description
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quality of life score
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Timepoint
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At the beginning of the study and at the end of the third month of the study
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Method of measurement
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Quality of life questionnaire SF-36
2
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Description
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Diarrhea
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Timepoint
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during the study
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Method of measurement
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questionnaire of patient-reported side effects
3
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Description
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Stomach ache
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Timepoint
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during the study
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Method of measurement
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questionnaire of patient-reported side effects
Intervention groups
1
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Description
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Intervention group: Olive leaf extract (capsule) is given orally three times a day for three consecutive months.
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Category
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Treatment - Drugs
2
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Description
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Control group: Pregabalin is prescribed orally twice a day for three consecutive months.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kermanshah University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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Pain scores and quality of life scores at the beginning and end of the study are shared.
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When the data will become available and for how long
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The access period starts 6 months after printing the results
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To whom data/document is available
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Researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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Compliance with professional ethics in the use of data
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From where data/document is obtainable
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Send an email to the responsible person
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What processes are involved for a request to access data/document
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After reviewing the qualifications of the requesting person, the information is sent to researcher by email at most three months.
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Comments
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