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Comparison of the effect of jujube and turmeric extract on serum adiponectin, sexual function and estradiol hormones profiling in the female population

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History
# Registration date Revision Id
2 2021-07-19, 1400/04/28 191252
1 2021-06-10, 1400/03/20 185936
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  • General information

    Not blinded
    Triple blinded
    1
    1
    1
    empty
    After the study, the study was performed in triple- blinds.
    empty
    پس از انجام مطالعه مطالعه به صورت سه سوکور انجام شد.
    The present study is a triple-blind study and the researcher and the patient and analyst will be unaware of the treatment and grouping of the study. For this purpose, turmeric extract and placebo are encoded by another person. The main researcher intervenes patients in a triple-blind manner based on the code of drug packages. The drug code is recorded on the demographic information completion form. Intervention in the target group will be turmeric extract for 8 weeks at a rate of 300 kg / mg Placebo will be prepared in a similar way to turmeric extract without its effective ingredients. 8 weeks after using turmeric extract, again in women of both groups A venous blood sample will be taken.
    مطالعه حاضر از نوع سه سوکور بوده و پژوهشگر و بیمار و فرد انجام دهنده آنالیز داده ها از نحوه درمان و گروه بندي مطالعه بی اطلاع خواهند ماند. براي این منظور عصاره گیاه زردچوبه و پلاسبو توسط شخص دیگری کدبندي میشود. محقق اصلی بر اساس کد بسته هاي دارویی بیماران را بصورت سه سوکور تحت مداخله قرار می دهد. کد مربوط به دارو بر روي فرم تکمیل اطلاعات دموگرافیک ثبت میشود. مداخله در گروه هدف به صورت استفاده از عصاره گیاه زردچوبه به مدت 4 هفته به میزان 300 میلی گرم بر کیلوگرم خواهد بود پلاسبو نیز با روشی مشابه عصاره گیاه زردچوبه و بدون ترکیبات موثر آن تهیه خواهد شد.4 هفته پس از استفاده از عصاره زردچوبه ، در زنان هر دو گروه مجددا اقدام به گرفتن نمونه خون وریدي خواهد شد

  • Recruitment centers

    #1
    Name of recruitment center - English: مرکز بهداشت دانشگاه لنگرود
    Name of recruitment center - Persian: University of Langroud Health Center
    Full name of responsible person - English: رامین غلامرود سیگارودی
    Full name of responsible person - Persian: ramin gholamrod sigarodi
    Street address - English: خیابان شهید بهشتی - شبکه بهداشت و درمان شهرستان لنگرود
    Street address - Persian: shahid behshti street. langerod health center
    City - English: گیلان
    City - Persian: gilan
    Province: Guilan
    Country: Iran (Islamic Republic of)
    Postal code: 1383657631
    Phone: +98 13 4252 4454
    Fax:
    Email: e.sadeghi@gmail.com
    Web page address:
    Name of recruitment center - English: shohada yaft abad hospital
    Name of recruitment center - Persian: بیمارستان شهدا یافت آباد
    Full name of responsible person - English: Najmeh Tehranian
    Full name of responsible person - Persian: نجمه تهرانیان
    Street address - English: Tehran.alghadir squer
    Street address - Persian: تهران.بلوار الغدیر
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1383657631
    Phone: +98 21 6524 5500
    Fax:
    Email: tehranian@modares.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Tarbiat modares univecity
    Name of organization / entity - Persian: دانشگاه تربیت مدرس
    Full name of responsible person - English: Dr Fathi
    Full name of responsible person - Persian: دکتر فتحی
    Street address - English: Jalal al ahmad
    Street address - Persian: جلال آل احمد
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1383957631
    Phone: +98 21 8288 3589
    Fax:
    Email: sadeghi.se22@gmail.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Tarbiat modares univecity
    Name of organization / entity - Persian: دانشگاه تربیت مدرس
    Full name of responsible person - English: Najmeh Tehranian
    Full name of responsible person - Persian: نجمه تهرانیان
    Street address - English: Jalal al ahmad
    Street address - Persian: جلال آل احمد
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1383957631
    Phone: +98 21 8288 3589
    Fax:
    Email: pres@modares.ac.ir
    Web page address:

  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Tarbiat Modares university
    Name of organization / entity - Persian: دانشگاه تربیت مدرس
    Full name of responsible person - English: Elahe Sadeghi Sahebzad
    Full name of responsible person - Persian: الهه صادقی صاحب زاد
    Position - English: student
    Position - Persian: دانشجو
    Latest degree: master
    Area of specialty/work: 53
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Jalal al Ahmad
    Street address - Persian: جلال آل احمد
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1383657631
    Phone: +98 21 6660 9606
    Mobile: +98 912 478 5098
    Fax:
    Email: sadeghi.se22@gmail.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Tarbiat Modares university
    Name of organization / entity - Persian: دانشگاه تربیت مدرس
    Full name of responsible person - English: Najmeh Tehrnian
    Full name of responsible person - Persian: نجمه تهرانیان
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: phd
    Area of specialty/work: 69
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Jalal al Ahmad
    Street address - Persian: جلال آل احمد
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1383657631
    Phone: +98 21 6660 9606
    Mobile: +98 912 327 0155
    Fax:
    Email: tehranian@modares.ac.ir
    Web page address:

  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Tarbiat Modares univesity
    Name of organization / entity - Persian: دانشگاه تربیت مدرس
    Full name of responsible person - English: Elahe Sadeghi Sahebzad
    Full name of responsible person - Persian: الهه صادقی صاحب زاد
    Position - English: student
    Position - Persian: دانشجو
    Latest degree: master
    Area of specialty/work: 53
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Jalal al ahmad
    Street address - Persian: جلال آل احمد
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1383657631
    Phone: +98 21 6660 9606
    Mobile: +98 912 478 5098
    Fax:
    Email: sadeghi.se22@gmail.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Tarbiat Modares univesity
    Name of organization / entity - Persian: دانشگاه تربیت مدرس
    Full name of responsible person - English: Faraz Mojab
    Full name of responsible person - Persian: فراز مجاب
    Position - English: Associate professor
    Position - Persian: دانشیار
    Latest degree: phd
    Area of specialty/work: 41
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Jalal al ahmad
    Street address - Persian: جلال آل احمد
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1383657631
    Phone: +98 21 6660 9606
    Mobile: +98 912 334 8721
    Fax:
    Email: sfmojab@sbmu.ac.ir
    Web page address:

  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Tarbiat Modares university
    Name of organization / entity - Persian: دانشگاه تربیت مدرس
    Full name of responsible person - English: Elahe Sadeghi Sahebzad
    Full name of responsible person - Persian: الهه صادقی صاحب زاد
    Position - English: student
    Position - Persian: دانشجو
    Latest degree: master
    Area of specialty/work: 53
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Jalal al ahmad
    Street address - Persian: جلال آل احمد
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1383657631
    Phone: +98 66609606
    Mobile: +98 912 478 5098
    Fax:
    Email: sadeghi.se22@gmail.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Tarbiat Modares university
    Name of organization / entity - Persian: دانشگاه تربیت مدرس
    Full name of responsible person - English: Najmeh Tehranian
    Full name of responsible person - Persian: نجمه تهرانیان
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: phd
    Area of specialty/work: 69
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Jalal al ahmad
    Street address - Persian: جلال آل احمد
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1383657631
    Phone: +98 66609606
    Mobile: +98 912 327 0155
    Fax:
    Email: tehranian@modares.ac.ir
    Web page address:

Protocol summary

Study aim
Comparison of the effect of jujube and turmeric extract on serum adiponectin, sexual function and estradiol hormones profiling in the female
Design
Phase 2 clinical trial with control group and 15 people in each group, With parallel groups, placebo-controlled clinical trial, Simple individual randomization with envelope
Settings and conduct
A placebo-controlled randomized clinical trial in women of reproductive age 18 to 45 years with poor sexual function and moderate or high stress levels. Sampling method: After obtaining informed consent, purposeful sampling was performed among the female volunteers who referred to the centers and met the inclusion criteria.
Participants/Inclusion and exclusion criteria
be Persian and Farsi Married and currently lives with her husband Not currently pregnant or have child breastfeeding dont be Infertile dont have any Abortion and delivery of cesarean section There is no history of medical problems such as diabetes and hypertension, psychological diseases, hip infections, pelvic pathological and other medical problems. her contraceptive methods are not hormonal. Over the past three months, they have not used drugs that interfere with sexual function. have Normal BMI (between18.9 and24.9) No use of special diets like vegetarianism
Intervention groups
Use of 300 mg turmeric extract capsules daily in women with poor sexual function and high moderate stress levels and the use of placebo in the control group
Main outcome variables
Sexual function. Steroid hormones

General information

Reason for update
After the study, the study was performed in triple- blinds.
Acronym
IRCT registration information
IRCT registration number: IRCT20190219042768N1
Registration date: 2021-06-10, 1400/03/20
Registration timing: retrospective

Last update: 2021-07-22, 1400/04/31
Update count: 1
Registration date
2021-06-10, 1400/03/20
Registrant information
Name
elahe sadeghi sahebzad
Name of organization / entity
Tarbiat modares university
Country
Iran (Islamic Republic of)
Phone
+98 21 6660 9606
Email address
e.sadeghisahebzad@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-21, 1399/07/30
Expected recruitment end date
2021-04-21, 1400/02/01
Actual recruitment start date
2020-10-21, 1399/07/30
Actual recruitment end date
2021-04-21, 1400/02/01
Trial completion date
2021-04-21, 1400/02/01
Scientific title
Comparison of the effect of jujube and turmeric extract on serum adiponectin, sexual function and estradiol hormones profiling in the female population
Public title
Comparison of the effect of jujube and turmeric extract on serum adiponectin, sexual function and estradiol hormones profiling in the female population
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
be Persian and Farsi Married and currently lives with her husband Not currently pregnant or have child breastfeeding dont be Infertile dont have any Abortion and delivery of cesarean section There is no history of medical problems such as diabetes and hypertension, psychological diseases, hip infections, pelvic pathological and other medical problems. her contraceptive methods are not hormonal. Over the past three months, they have not used drugs that interfere with sexual function. have Normal BMI (between 18.9 and 24.9) No use of special diets like vegetarianism Poor sexual function according to the FSFI questionnaire Moderate to severe stress levels based on the DOS questionnaire
Exclusion criteria:
good sexual function Mild stress
Age
From 19 years old to 45 years old
Gender
Female
Phase
1-2
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 30
Actual sample size reached: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization of an individual with an envelope in dividing the groups into two groups A and B. In this method, we selected a number of cards or letters as the intervention group and the same number of cards for the control group, then merged the cards together. One card was taken out and its allocation was recorded, and after the card was taken out, we returned it again to all the other cards. Then the cards are merged again and we take out another card. This process continues until a random sequence is reached according to the sample size.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The present study is a triple-blind study and the researcher and the patient and analyst will be unaware of the treatment and grouping of the study. For this purpose, turmeric extract and placebo are encoded by another person. The main researcher intervenes patients in a triple-blind manner based on the code of drug packages. The drug code is recorded on the demographic information completion form. Intervention in the target group will be turmeric extract for 8 weeks at a rate of 300 kg / mg Placebo will be prepared in a similar way to turmeric extract without its effective ingredients. 8 weeks after using turmeric extract, again in women of both groups A venous blood sample will be taken.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of tarbiat modares university
Street address
jalal alahmad
City
tehran
Province
Tehran
Postal code
1383957631
Approval date
2019-01-12, 1397/10/22
Ethics committee reference number
ir.modares.rec.1397.206

Health conditions studied

1

Description of health condition studied
sexual dysfunction
ICD-10 code
F52.8
ICD-10 code description
Other sexual dysfunction not due to a substance or known physiological condition

Primary outcomes

1

Description
Sexual dysfunction.
Timepoint
before and after intervention
Method of measurement
questionnaire

2

Description
Steroidal hormones
Timepoint
before and after intervention
Method of measurement
laboratory kits

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: treatment with turmeric extract will be 300 mg for 4 weeks. This article has been extracted and concentrated by Dr. Elaheh Sadeghi under the supervision of Dr. Mohsen Sharifi, Professor, Department of Plant Physiology, Faculty of Basic Sciences, Tarbiat Modarres University, Iran
Category
Treatment - Drugs

2

Description
Control group: treatment by placebo, Placebo will be prepared in a similar way to turmeric extract without its effective ingredients. 4 weeks after using , women in both groups will have venous blood sampling again.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
shohada yaft abad hospital
Full name of responsible person
Najmeh Tehranian
Street address
Tehran.alghadir squer
City
Tehran
Province
Tehran
Postal code
1383657631
Phone
+98 21 6524 5500
Email
tehranian@modares.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tarbiat modares univecity
Full name of responsible person
Najmeh Tehranian
Street address
Jalal al ahmad
City
Tehran
Province
Tehran
Postal code
1383957631
Phone
+98 21 8288 3589
Fax
Email
pres@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat modares univecity
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
Tarbiat Modares university
Full name of responsible person
Najmeh Tehrnian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Jalal al Ahmad
City
Tehran
Province
Tehran
Postal code
1383657631
Phone
+98 21 6660 9606
Email
tehranian@modares.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat Modares univesity
Full name of responsible person
Faraz Mojab
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Jalal al ahmad
City
Tehran
Province
Tehran
Postal code
1383657631
Phone
+98 21 6660 9606
Email
sfmojab@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tarbiat Modares university
Full name of responsible person
Najmeh Tehranian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Jalal al ahmad
City
Tehran
Province
Tehran
Postal code
1383657631
Phone
+98 66609606
Email
tehranian@modares.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
No - There is not 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
Only part of the information
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Scientific and research studies
Under which criteria data/document could be used
With sample permission
From where data/document is obtainable
E-mail
What processes are involved for a request to access data/document
Ethics Committee. Investigation proceedings
Comments
One week to one month
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