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Protocol summary
Inclusion criteria: Women with type 2 diabetes from at least 3 years ago till now and mild to moderate systolic blood pressure (13-15 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.
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.
Inclusion criteria: Women with type 2 diabetes from at least 3 years ago till now and mild to moderate systolic blood pressure (13120-15159 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.
شرایط ورود : زنان مبتلا به دیابت نوع دو با سابقه حداقل 3 سال ابتلا به بیماری دیابت و فشارخون سیستولیک خفیف تا متوسط (15-13 میلی متر جیوه)
شرایط عدم ورود : مصرف انسولین، مصرف روزانه هرگونه مکمل بجز مولتی ویتامین، ابتلا به بیماریهای عمده ای چون سرطان، آسم و نارسایی قلبی و سایر مشکلات قلبی و عروقی و بارداری و شیردهی
شرایط ورود : زنان مبتلا به دیابت نوع دو با سابقه حداقل 3 سال ابتلا به بیماری دیابت و فشارخون سیستولیک خفیف تا متوسط (159-120 میلی متر جیوه)
شرایط عدم ورود : مصرف انسولین، مصرف روزانه هرگونه مکمل بجز مولتی ویتامین، ابتلا به بیماریهای عمده ای چون سرطان، آسم و نارسایی قلبی و سایر مشکلات قلبی و عروقی و بارداری و شیردهی
شرایط ورود : زنان مبتلا به دیابت نوع دو با سابقه حداقل 3 سال ابتلا به بیماری دیابت و فشارخون سیستولیک خفیف تا متوسط (15159-13120 میلی متر جیوه) شرایط عدم ورود : مصرف انسولین، مصرف روزانه هرگونه مکمل بجز مولتی ویتامین، ابتلا به بیماریهای عمده ای چون سرطان، آسم و نارسایی قلبی و سایر مشکلات قلبی و عروقی و بارداری و شیردهی
General information
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2018-08-12, 1397/05/21
2018-07-29, 1397/05/07
2018-0807-1229 00:00:00
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2018-07-29, 1397/05/07
2018-07-29 00:00:00
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2018-09-16, 1397/06/25
2018-09-16 00:00:00
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2018-09-16, 1397/06/25
2018-09-16 00:00:00
Female
At least three years of type 2 diabetes history
Having mild to moderate systolic blood pressure (15-13 mm Hg)
Female
At least three years of type 2 diabetes history
Having mild to moderate systolic blood pressure (120-159 mm Hg)
Female At least three years of type 2 diabetes history Having mild to moderate systolic blood pressure (15120-13159 mm Hg)
جنس مونث
حداقل سه سال سابقه ابتلا به دیابت نوع دو
دارای فشارخون سیستولیک خفیف تا متوسط(15-13 میلی متر جیوه)
جنس مونث
حداقل سه سال سابقه ابتلا به دیابت نوع دو
دارای فشارخون سیستولیک خفیف تا متوسط(159-120میلی متر جیوه)
جنس مونث حداقل سه سال سابقه ابتلا به دیابت نوع دو دارای فشارخون سیستولیک خفیف تا متوسط(15متوسط(159-13 میلی120میلی متر جیوه)
Male
Having type 1 diabetes
Insulin usage
Daily usage of any supplement except multivitamin
Suffering from any major diseases such as cancer, asthma , heart failure and other cardiovascular Disorders
Pregnancy and lactation
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
Male Having type 1 diabetes Insulin usage Daily usage of any supplement except multivitamin Suffering from any major diseases such as cancer, asthma , heart failure and other cardiovascular Disorders Pregnancy and lactation
جنس مرد
ابتلا به دیابت نوع یک
مصرف انسولین
مصرف روزانه هرگونه مکمل بجز مولتی ویتامین
ابتلا به بیماریهای عمده ای چون سرطان، آسم و نارسایی قلبی و سایر مشکلات قلبی و عروقی
بارداری و شیردهی
جنس مرد
ابتلا به دیابت نوع یک
مصرف انسولین
مصرف روزانه هرگونه مکمل مولتی ویتامین
ابتلا به بیماریهای عمده ای چون سرطان، آسم و نارسایی قلبی و سایر مشکلات قلبی و عروقی
بارداری و شیردهی
جنس مرد ابتلا به دیابت نوع یک مصرف انسولین مصرف روزانه هرگونه مکمل بجز مولتی ویتامین ابتلا به بیماریهای عمده ای چون سرطان، آسم و نارسایی قلبی و سایر مشکلات قلبی و عروقی بارداری و شیردهی
Recruitment centers
#1
Name of recruitment center - English: کلینیک دیابت بیمارستان امام خمینی
Name of recruitment center - Persian: Imam Khomeini Hospital Diabetes Clinic
Full name of responsible person - English: Dr Manoochehr khan nakhjavani
Full name of responsible person - Persian: دکتر منوچهرخان نخجوانی
Street address - English: Keshavarz Blvd., Dr. Gharib Ave., Imam Khomeini Hospital Complex
Street address - Persian: انتهای بلوار کشاورز، خیابان دکتر قریب، مجتمع بیمارستان امام خمینی(ره)
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1419733141
Phone: +98 21 6119 2281
Fax:
Email: Orouji@health.gov.ir
Web page address: http://ikhc2.tums.ac.ir/
Name of recruitment center - English: Diabetic Clinic of Imam Khomeini Hospital
Name of recruitment center - Persian: کلینیک دیابت بیمارستان امام خمینی
Full name of responsible person - English: Dr. Manouchehr Khan Nakhjavani
Full name of responsible person - Persian: دکتر منوچهرخان نخجوانی
Street address - English: Imam Khomeini Hospital, Dr Gharib Ave, end of Keshavarz Blvd
Street address - Persian: انتهای بلوار کشاورز، خیابان دکتر قریب، مجتمع بیمارستان امام خمینی(ره)
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1419733141
Phone: +98 21 6119 2281
Fax:
Email: Orouji@health.gov.ir
Web page address: http://ikhc2.tums.ac.ir/
Name of recruitment center - English: کلینیک دیابت بیمارستان امام خمینیDiabetic Clinic of Imam Khomeini Hospital Name of recruitment center - Persian: Imam Khomeini Hospital Diabetes Clinicکلینیک دیابت بیمارستان امام خمینی Full name of responsible person - English: Dr Manoochehr khan nakhjavani. Manouchehr Khan Nakhjavani Full name of responsible person - Persian: دکتر منوچهرخان نخجوانی Street address - English: Keshavarz Blvd., Dr. Gharib Ave., Imam Khomeini Hospital Complex, Dr Gharib Ave, end of Keshavarz Blvd Street address - Persian: انتهای بلوار کشاورز، خیابان دکتر قریب، مجتمع بیمارستان امام خمینی(ره) City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1419733141 Phone: +98 21 6119 2281 Fax: Email: Orouji@health.gov.ir Web page address: http://ikhc2.tums.ac.ir/
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Payame Noor University
Name of organization / entity - Persian: دانشگاه پیام نور
Full name of responsible person - English: Dr Reza hajihosseini
Full name of responsible person - Persian: دکتر رضا حاجی حسینی
Street address - English: Tehran, Hakimiyeh, Water Organization Street, 15th Street, Shirazi, No. 3
Street address - Persian: تهران،حکیمیه،خیابان سازمان آب،خیابان 15متری شیرازی،پلاک 3
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1659639884
Phone: +98 21 7731 1286
Fax: +98 21 7731 8537
Email: hosseini@pnu.ac.ir
Web page address: http://teh-shargh.pnu.ac.ir/Portal/Home/
contact.organization_id:
Name of organization / entity - English: Payam Noor University
Name of organization / entity - Persian: دانشگاه پیام نور
Full name of responsible person - English: Dr. Reza Haji Hosseini
Full name of responsible person - Persian: دکتر رضا حاجی حسینی
Street address - English: No. 3, Hakimeh, Panzdah Metri Shirazi Ave, Sazeman Abb St, Hakimieh.
Street address - Persian: حکیمیه،خیابان سازمان آب،خیابان 15متری شیرازی،پلاک 3
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1659639884
Phone: +98 21 7731 1286
Fax: +98 21 7731 8537
Email: hosseini@pnu.ac.ir
Web page address: http://teh-shargh.pnu.ac.ir/Portal/Home/
contact.organization_id: Name of organization / entity - English: PayamePayam Noor University Name of organization / entity - Persian: دانشگاه پیام نور Full name of responsible person - English: Dr. Reza hajihosseiniHaji Hosseini Full name of responsible person - Persian: دکتر رضا حاجی حسینی Street address - English: Tehran, Hakimiyeh, Water Organization Street, 15th Street, Shirazi, No. 3, Hakimeh, Panzdah Metri Shirazi Ave, Sazeman Abb St, Hakimieh. Street address - Persian: تهران،حکیمیه،خیابان سازمان آب،خیابان 15متری شیرازی،پلاک 3 City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1659639884 Phone: +98 21 7731 1286 Fax: +98 21 7731 8537 Email: hosseini@pnu.ac.ir Web page address: http://teh-shargh.pnu.ac.ir/Portal/Home/
Trial results
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The results of this study indicated that daily consumption of 100 mg of Oligopin supplement for six weeks as a supplementary drug was effective on systolic blood pressure and LDL and had no significant effect on FBS and HDL
The results of this study indicated that daily consumption of 100 mg of Oligopin supplement for six weeks as a supplementary drug was effective on systolic blood pressure and LDL and had no significant effect on FBS and HDL
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نتايج حاضر بیانگر آن است که مصرف روزانه 100 میلی گرم مکمل الیگوپین به مدت شش هفته بعنوان داروی مکمل، بر فشارخون سیستولیک و LDL موثر بوده و بر FBS و HDL تاثیر معناداری مشاهده نگردید.
نتايج حاضر بیانگر آن است که مصرف روزانه 100 میلی گرم مکمل الیگوپین به مدت شش هفته بعنوان داروی مکمل، بر فشارخون سیستولیک و LDL موثر بوده و بر FBS و HDL تاثیر معناداری مشاهده نگردید.
Protocol summary
Study aim
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
Design
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).
Settings and conduct
This research will be conducted in the clinic of diabetes of Imam Khomeini Hospital in Tehran.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
Fasting blood glucose, Low density lipoprotein, High density lipoprotein &Systolic blood pressure
General information
Reason for update
Acronym
IRCT registration information
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
Registration date
2018-08-04, 1397/05/13
Registrant information
Name
Rasool Orouji
Name of organization / entity
Payame Noor University
Country
Iran (Islamic Republic of)
Phone
+98 21 4410 3316
Email address
orouji@health.gov.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-29, 1397/05/07
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
2018-07-29, 1397/05/07
Actual recruitment end date
2018-09-16, 1397/06/25
Trial completion date
2018-09-16, 1397/06/25
Scientific title
The effect of French Maritime Pine Bark Extract ( Oligopin® ) on FBS, LDL ,HDL and systolic blood pressure in women with type II diabetic
Public title
Evaluation of the effect of French Maritime Pine Bark Extract on selected blood type indices in type 2 diabetic women
Purpose
Prevention
Inclusion/Exclusion criteria
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
Age
From 45 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
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
Blinding (investigator's opinion)
Double blinded
Blinding description
Thirty people are randomly will be assign to one of two homogeneous supplement and placebo groups of 15 people each.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
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Ethics committees
1
Ethics committee
Name of ethics committee
Payam Noor University ethics committee
Street address
Payame Noor University Headquarter, Nakhl Alley ,the beginning of Shahrak Naft township, Artesh Blvd, Mini City, Tehran.
City
Tehran
Province
Tehran
Postal code
193954697
Approval date
2018-06-09, 1397/03/19
Ethics committee reference number
IR.PNU.REC.1397.009
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Fasting blood glucose, Low density lipoprotein, High density lipoprotein &Systolic blood pressure
Timepoint
Blood sampling is two times before and after supplement take (beginning of the study and six weeks after supplement take)
Method of measurement
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.
Secondary outcomes
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Intervention groups
1
Description
Intervention group: French Marine Pine Extract (Oligopin) users
Category
Prevention
2
Description
Control group: Placebo users
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetic Clinic of Imam Khomeini Hospital
Full name of responsible person
Dr. Manouchehr Khan Nakhjavani
Street address
Imam Khomeini Hospital, Dr Gharib Ave, end of Keshavarz Blvd