Protocol summary
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Study aim
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French Maritime Pine Bark Extract antidiabetic effects and cardiovascular risk factors improvement review.
Encouraging diabetic patients to use French Maritime Pine Bark Extract as alternative for chemically decreasing glucose agents, and metabolic syndrome risk factors improvement after supplement using
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Design
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The present study was designed in a double blinded randomized clinical trial in two groups of placebo and placebo with blood sampling in two rounds (before and after supplement take).
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Settings and conduct
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This research will be conducted in the clinic of diabetes of Imam Khomeini Hospital in Tehran.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Women with type 2 diabetes from at least 3 years ago till now and mild to moderate systolic blood pressure (120-159 mm Hg)
Exclusion criteria: Insulin usage, pregnancy and lactation, daily use of any supplement except multivitamin, major diseases such as cancer, asthma , heart failure and other cardiovascular problems.
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Intervention groups
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The only intervention in this project is French Maritime Pine Bark Extract (Oligopin) use and the complementary placebo in two randomized groups of 15 people each.
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Main outcome variables
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Fasting blood glucose, Low density lipoprotein, High density lipoprotein &Systolic blood pressure
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:
IRCT20180718040512N1
Registration date:
2018-08-04, 1397/05/13
Registration timing:
registered_while_recruiting
Last update:
2019-03-12, 1397/12/21
Update count:
1
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Registration date
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2018-08-04, 1397/05/13
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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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2018-07-29, 1397/05/07
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Expected recruitment end date
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2018-09-23, 1397/07/01
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Actual recruitment start date
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2018-07-29, 1397/05/07
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Actual recruitment end date
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2018-09-16, 1397/06/25
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Trial completion date
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2018-09-16, 1397/06/25
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Scientific title
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The effect of French Maritime Pine Bark Extract ( Oligopin® ) on FBS, LDL ,HDL and systolic blood pressure in women with type II diabetic
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Public title
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Evaluation of the effect of French Maritime Pine Bark Extract on selected blood type indices in type 2 diabetic women
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Female
At least three years of type 2 diabetes history
Having mild to moderate systolic blood pressure (120-159 mm Hg)
Exclusion criteria:
Male
Having type 1 diabetes
Insulin usage
Daily usage of any supplement multivitamin
Suffering from any major diseases such as cancer, asthma , heart failure and other cardiovascular Disorders
Pregnancy and lactation
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Age
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From 45 years old to 65 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
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Sample size
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Target sample size:
30
Actual sample size reached:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Following notification and inviting the patients for further cooperation in the research project, the goals and research methodology were provided to the them and filled the informed consent& questionnaires.A sample of 30 people divided randomly into two homogenous groups of 15 people each. One group uses two 50 mg capsules of oligopin supplement per day for 6 weeks and in the same time the other group will use proprietary placebo
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Thirty people are randomly will be assign to one of two homogeneous supplement and placebo groups of 15 people each.
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Placebo
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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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2018-06-09, 1397/03/19
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Ethics committee reference number
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IR.PNU.REC.1397.009
Health conditions studied
1
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Description of health condition studied
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Type 2 diabetes
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ICD-10 code
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E08
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ICD-10 code description
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Diabetes mellitus due to underlying condition
Primary outcomes
1
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Description
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Fasting blood glucose, Low density lipoprotein, High density lipoprotein &Systolic blood pressure
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Timepoint
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Blood sampling is two times before and after supplement take (beginning of the study and six weeks after supplement take)
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Method of measurement
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The variable of blood pressure is taken by a digital barometric device in the clinic, and other blood biochemical variables will be performed by the relevant specialist in the clinic laboratory.
Intervention groups
1
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Description
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Intervention group: French Marine Pine Extract (Oligopin) users
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Category
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Prevention
2
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Description
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Control group: Placebo users
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Category
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Placebo
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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Payam Noor University
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Proportion provided by this source
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1
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Public or private sector
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Private
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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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Other
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Due to the confidentiality of the research participants, information, I do not intend to publish the research participants, data.
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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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No - There is not 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