Effect of oral balck cumin (Nigella Sativa) supplement on the expression of genes involved in adipogenesis and serum concentrations of liver enzymes and lipid profiles among obese and overweight women
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Protocol summary
Effect of oral balck cumin (Nigella Sativa) supplement on the expression of genes involved in adipogenesis using NGS method and serum concentrations of liver enzymes and lipid profiles among obese women
Effect of oral black cumin (Nigella Sativa) supplement on the expression of genes involved in adipogenesis and serum concentrations of liver enzymes and lipid profiles among obese and overweight women
Effect of oral balckblack cumin (Nigella Sativa) supplement on the expression of genes involved in adipogenesis using NGS method and serum concentrations of liver enzymes and lipid profiles among obese and overweight women
بررسی اثر مکمل خوراکی زیره سیاه (Nigella Sativa) بر بیان ژن های مرتبط با آدیپوژنز در زنان چاق ، به روش NGS و سطوح سرمی آنزیم های کبدی و پروفایل لیپیدی در زنان چاق
بررسی اثر مکمل خوراکی زیره سیاه (Nigella Sativa) بر بیان ژن های مرتبط با آدیپوژنز در زنان چاق و سطوح سرمی آنزیم های کبدی و پروفایل لیپیدی در زنان چاق و دارای اضافه وزن
بررسی اثر مکمل خوراکی زیره سیاه (Nigella Sativa) بر بیان ژن های مرتبط با آدیپوژنز در زنان چاق ، به روش NGS و سطوح سرمی آنزیم های کبدی و پروفایل لیپیدی در زنان چاق و دارای اضافه وزن
This is a cross-over randomized placebo controlled double blind clinical trial.
The target group consisted of 24 obese women who will randomly assigned into one of the two groups. Duration of the intervention consisted of 2 periods of 2 months;
This is a cross-over randomized placebo controlled double blind clinical trial.
The target group consisted of 35 women who will randomly assigned into one of the two groups. Duration of the intervention consisted of 2 periods of 2 months;
This is a cross-over randomized placebo controlled double blind clinical trial. The target group consisted of 24 obese35 women who will randomly assigned into one of the two groups. Duration of the intervention consisted of 2 periods of 2 months;
از شیوه کارازمایی بالینی تصادفی دوسوکور شاهد دار با دارونما و با طراحی متقاطع استفاده خواهد شد.
گروه هدف 24 نفر زنان چاق که، به طور تصادفی در یکی از 2 گروه موجود قرار می گیرند. مدت زمان مداخله 2 دوره 2 ماهه است
از شیوه کارازمایی بالینی تصادفی دوسوکور شاهد دار با دارونما و با طراحی متقاطع استفاده خواهد شد.
گروه هدف 35 نفر زنان که، به طور تصادفی در یکی از 2 گروه موجود قرار می گیرند. مدت زمان مداخله 2 دوره 2 ماهه است
از شیوه کارازمایی بالینی تصادفی دوسوکور شاهد دار با دارونما و با طراحی متقاطع استفاده خواهد شد. گروه هدف 2435 نفر زنان چاق که، به طور تصادفی در یکی از 2 گروه موجود قرار می گیرند. مدت زمان مداخله 2 دوره 2 ماهه است
Obese healthy women who will be referred to Imam Ali hospital in Yazd city, will be recruited and will be randomly divided into 2 groups of supplement and placebo; capsules will be given in a double-blind process; participants and researchers will be blinded to the content. Blood collection will be done to assess the biochemical factors at the beginning and the end of each period; abdominal tissue samples will be randomly taken from 10 women at the end of each intervention period in the Internal section of hospital. RTPCR test will be performed on blood samples. after a 1-month washout, all the mentioned procedures will be done for the second period.
Obese and overweight healthy women who will be referred to Imam Ali hospital in Yazd city, will be recruited and will be randomly divided into 2 groups of supplement and placebo; capsules will be given in a double-blind process; participants and researchers will be blinded to the content. Blood collection will be done to assess the biochemical factors at the beginning and the end of each period; RNA will be extracted from the blood of all participants before and after every intervention in the Internal section of hospital. RTPCR test will be performed on blood samples. After a 1-month washout, all the mentioned procedures will be done for the second period.
Obese and overweight healthy women who will be referred to Imam Ali hospital in Yazd city, will be recruited and will be randomly divided into 2 groups of supplement and placebo; capsules will be given in a double-blind process; participants and researchers will be blinded to the content. Blood collection will be done to assess the biochemical factors at the beginning and the end of each period; abdominal tissue samplesRNA will be randomly takenextracted from 10 women at the endblood of eachall participants before and after every intervention period in the Internal section of hospital. RTPCR test will be performed on blood samples. afterAfter a 1-month washout, all the mentioned procedures will be done for the second period.
زنان چاق سالم که به منظور کاهش وزن به بیمارستان امام علی یزد، مراجعه خواهند کرد، انتخاب شده و به صورت تصادفی به دو گروه مکمل و دارونما تقسیم میشوند.بسته ها به صورت دوسوکور به افراد داده میشود، شرکتکننده و محقق از محتوای مکمل با خبر نخواهند بود.خونگیری به منظور بررسی فاکتورهای بیوشیمیایی در ابتدا و انتهای هر دوره از همه افراد در بخش داخلی بیمارستان گرفته میشود. RNA از نمونه بافت چربی شکمی که در انتهای هر دوره از 10 نفرتصادفی گرفته شده و پروسه توالی ژنتیکی بررسی می شود. تست RTPCR نیز از نمونه های خون گرفته شده بعد از مداخله انجام خواهد شد. بعد از 2 ماه مداخله اول، 1 ماه دروه پاکسازی خواهد بود و سپس همه مراحل قبلی گفته شده برای دوره 2 ماهه دوم انجام میشود.
زنان چاق و دارای اضافه وزن سالم که به منظور کاهش وزن به بیمارستان امام علی یزد، مراجعه خواهند کرد، انتخاب شده و به صورت تصادفی به دو گروه مکمل و دارونما تقسیم میشوند.بسته ها به صورت دوسوکور به افراد داده میشود، شرکت کننده و محقق از محتوای مکمل با خبر نخواهند بود.خونگیری به منظور بررسی فاکتورهای بیوشیمیایی در ابتدا و انتهای هر دوره از همه افراد گرفته میشود. RNA از نمونه خون همه افراد در ابتدا و انتهای هر دوره مداخله، در بخش داخلی بیمارستان گرفته می شود. تست RTPCR نیز از نمونه های خون گرفته شده بعد از مداخله انجام خواهد شد. بعد از 2 ماه مداخله اول، 1 ماه دروه پاکسازی خواهد بود و سپس همه مراحل قبلی گفته شده برای دوره 2 ماهه دوم انجام میشود.
زنان چاق و دارای اضافه وزن سالم که به منظور کاهش وزن به بیمارستان امام علی یزد، مراجعه خواهند کرد، انتخاب شده و به صورت تصادفی به دو گروه مکمل و دارونما تقسیم میشوند.بسته ها به صورت دوسوکور به افراد داده میشود، شرکتکنندهشرکت کننده و محقق از محتوای مکمل با خبر نخواهند بود.خونگیری به منظور بررسی فاکتورهای بیوشیمیایی در ابتدا و انتهای هر دوره از همه افراد در بخش داخلی بیمارستان گرفته میشود. RNA از نمونه بافت چربی شکمی کهخون همه افراد در ابتدا و انتهای هر دوره از 10 نفرتصادفیمداخله، در بخش داخلی بیمارستان گرفته شده و پروسه توالی ژنتیکی بررسی می شود. تست RTPCR نیز از نمونه های خون گرفته شده بعد از مداخله انجام خواهد شد. بعد از 2 ماه مداخله اول، 1 ماه دروه پاکسازی خواهد بود و سپس همه مراحل قبلی گفته شده برای دوره 2 ماهه دوم انجام میشود.
Inclusion criteria are healthy obese women aged 25 to 55 years old with the BMI ranges of 30 to 35 kg/m2; exclusion criteria includes the presence of allergy to the supplements during the intervention period or the use of less than 10% of the supplements.
Inclusion criteria are healthy obese and overweight women aged 27 to 55 years old with the BMI ranges of 27 to 35 kg/m2; exclusion criteria includes the presence of allergy to the supplements during the intervention period or the use of less than 10% of the supplements.
Inclusion criteria are healthy obese and overweight women aged 2527 to 55 years old with the BMI ranges of 3027 to 35 kg/m2; exclusion criteria includes the presence of allergy to the supplements during the intervention period or the use of less than 10% of the supplements.
شرایط ورود شامل زنان چاق سالم با نمایه توده بدنی بین 30 تا 35 kg/m2 و با دامنه سنی 25تا 55 سال می باشد؛ شرایط خروج شامل وجود حساسیت به مکمل مصرفی در طول دوره درمان و نیز مشرف کمتر از 10% از مکمل داده شده می باشد.
شرایط ورود شامل زنان دارای اضافه وزن و چاق سالم با نمایه توده بدنی بین 27تا 35 kg/m2 و با دامنه سنی 25تا 55 سال می باشد؛ شرایط خروج شامل وجود حساسیت به مکمل مصرفی در طول دوره درمان و نیز مشرف کمتر از 10% از مکمل داده شده می باشد.
شرایط ورود شامل زنان دارای اضافه وزن و چاق سالم با نمایه توده بدنی بین 30 تا27تا 35 kg/m2 و با دامنه سنی 25تا 55 سال می باشد؛ شرایط خروج شامل وجود حساسیت به مکمل مصرفی در طول دوره درمان و نیز مشرف کمتر از 10% از مکمل داده شده می باشد.
General information
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Effect of oral balck cumin (Nigella Sativa) supplement on the expression of genes involved in adipogenesis using NGS method and serum concentrations of liver enzymes and lipid profiles among obese women
Effect of oral balck cumin (Nigella Sativa) supplement on the expression of genes involved in adipogenesis and serum concentrations of liver enzymes and lipid profiles among obese and overweight women
Effect of oral balck cumin (Nigella Sativa) supplement on the expression of genes involved in adipogenesis using NGS method and serum concentrations of liver enzymes and lipid profiles among obese and overweight women
بررسی اثر مکمل خوراکی زیره سیاه (Nigella Sativa) بر بیان ژن های مرتبط با آدیپوژنز به روش NGS و سطوح سرمی آنزیم های کبدی و پروفایل لیپیدی در زنان چاق
بررسی اثر مکمل خوراکی زیره سیاه (Nigella Sativa) بر بیان ژن های مرتبط با آدیپوژنز و سطوح سرمی آنزیم های کبدی و پروفایل لیپیدی در زنان چاق و دارای اضافه وزن
بررسی اثر مکمل خوراکی زیره سیاه (Nigella Sativa) بر بیان ژن های مرتبط با آدیپوژنز به روش NGS و سطوح سرمی آنزیم های کبدی و پروفایل لیپیدی در زنان چاق و دارای اضافه وزن
Obese women whose obesity was defined according to WHO criteria.
The BMI range of participants should be between 30 to 35 kg/m2.
Age ranges should be 25 to 55 years old.
Healthy obese women will be interred to the study.
Obese women whose overweight and obesity were defined according to WHO criteria.
The BMI range of participants should be between 27 to 35 kg/m2.
Age ranges should be 25 to 55 years old.
Healthy overweight and obese women will be interred to the study.
Obese women whose overweight and obesity waswere defined according to WHO criteria. The BMI range of participants should be between 3027 to 35 kg/m2. Age ranges should be 25 to 55 years old. Healthy overweight and obese women will be interred to the study.
زنانی که چاقی آنها براساس شاخص سازمان بهداشت جهانی تعریف شده باشد.
محدوده نمایه توده بدنی افراد می بایست بین 30 تا 35 kg/m2 باشد.
دامنه سنی افراد می بایست بین 25تا 55 سال باشد؛
زنان چاق کاملا سالم وارد مطالعه خواهند شد.
زنانی که چاقی و اضافه وزن آنها براساس شاخص سازمان بهداشت جهانی تعریف شده باشد.
محدوده نمایه توده بدنی افراد می بایست بین 27 تا 35 kg/m2 باشد.
دامنه سنی افراد می بایست بین 25تا 55 سال باشد؛
زنان دارای اضافه وزن و چاق کاملا سالم وارد مطالعه خواهند شد.
زنانی که چاقی و اضافه وزن آنها براساس شاخص سازمان بهداشت جهانی تعریف شده باشد. محدوده نمایه توده بدنی افراد می بایست بین 3027 تا 35 kg/m2 باشد. دامنه سنی افراد می بایست بین 25تا 55 سال باشد؛ زنان دارای اضافه وزن و چاق کاملا سالم وارد مطالعه خواهند شد.
Health conditions studied
#1
Obesity
Obesity and overweight
Obesity and overweight
چاقی
چاق و اضافه وزن
چاقیچاق و اضافه وزن
Primary outcomes
#1
Two times; at the end of the first 2-month trial and at the end of the second 2-month trial
Four times; at the beginning and the end of the first 2-month trial and at beginning and the end of the second 2-month trial
TwoFour times; at the beginning and the end of the first 2-month trial and at beginning and the end of the second 2-month trial
2 بار ؛ 1 بار درانتهای مداخله 2 ماهه اول و 1 بار در انتهای مداخله 2 ماهه دوم
4 بار ؛ در ابتدا و انتهای مداخله 2 ماهه اول ريال درابتدا و در انتهای مداخله 2 ماهه دوم
24 بار ؛ 1 بار درانتهایدر ابتدا و انتهای مداخله 2 ماهه اول ريال درابتدا و 1 بار در انتهای مداخله 2 ماهه دوم
#2
Alteration in the Sequencing of Whole related genes with obesity and adipogenesis
Lipid profile
Alteration in the Sequencing of Whole related genes with obesity and adipogenesisLipid profile
تغییرات توالی تمام ژنهای مرتبط با چاقی و آدیپوژنز
سطوح چربی خون
تغییرات توالی تمام ژنهای مرتبط با چاقی و آدیپوژنزسطوح چربی خون
Two times; at the end of the first 2-month trial and at the end of the second 2-month trial
4 times; at the initiation and the end of the first 2-month trial and at the initiation and the end of the second 2-month trial
Two4 times; at the initiation and the end of the first 2-month trial and at the initiation and the end of the second 2-month trial
2 بار ؛ 1 بار درانتهای مداخله 2 ماهه اول و 1 بار در انتهای مداخله 2 ماهه دوم
4 بار ، ابتدا و و انتهای مداخله 2 ماهه اول؛ ابتدا و انتهاب مداخله 2 ماهه دوم
24 بار ؛ 1 بار درانتهای مداخله 2 ماهه اول، ابتدا و 1 بار درو انتهای مداخله 2 ماهه اول؛ ابتدا و انتهاب مداخله 2 ماهه دوم
Next generation sequencing (NGS) via developed machine having sensor to DNA
Assay kits (Padgin Teb Co.)
Next generation sequencingAssay kits (NGSPadgin Teb Co.) via developed machine having sensor to DNA
روش توالی یابی نسل جدید (NGS) با دستگاه پیشرفته دارای حسگر به DNA
کیت های Assay شرکت پادگین طب
روش توالی یابی نسل جدید (NGS) با دستگاه پیشرفته دارای حسگر به DNAکیت های Assay شرکت پادگین طب
4 times; at the initiation and the end of the first 2-month trial and at the initiation and the end of the second 2-month trial
empty
4 times; at the initiation and the end of the first 2-month trial and at the initiation and the end of the second 2-month trial
4 بار ، ابتدا و و انتهای مداخله 2 ماهه اول؛ ابتدا و انتهاب مداخله 2 ماهه دوم
empty
4 بار ، ابتدا و و انتهای مداخله 2 ماهه اول؛ ابتدا و انتهاب مداخله 2 ماهه دوم
Assay Kits (Pars Azmoon Co.)
empty
Assay Kits (Pars Azmoon Co.)
کیت های بررسی Assay (شرکت پارس آزمون)
empty
کیت های بررسی Assay (شرکت پارس آزمون)
Recruitment centers
#1
Name of recruitment center - English: کلینیک فوق تخصصی امام علی (ع)، وابسته به دانشگاه علوم پزشکی یزد
Name of recruitment center - Persian: Imam Ali clinic, related to Shahid Sadoughi University of Medical Sciences
Full name of responsible person - English: آزاده نجارزاده
Full name of responsible person - Persian: Azadeh Nadjarzadeh
Street address - English: Alem Square
Street address - Persian: میدان عالم
City - English: Yazd
City - Persian: یزد
Province: Yazd
Country: Iran (Islamic Republic of)
Postal code: 8915173160
Phone: +98 35 3630 1700
Fax:
Email: e_razmpoosh@yahoo.com
Web page address:
Name of recruitment center - English: Imam Ali clinic, related to Shahid Sadoughi University of Medical Sciences
Name of recruitment center - Persian: کلینیک فوق تخصصی امام علی (ع)، وابسته به دانشگاه علوم پزشکی یزد
Full name of responsible person - English: Azadeh Nadjarzadeh
Full name of responsible person - Persian: آزاده نجارزاده
Street address - English: Alem Square
Street address - Persian: میدان عالم
City - English: Yazd
City - Persian: یزد
Province: Yazd
Country: Iran (Islamic Republic of)
Postal code: 8915173160
Phone: +98 35 3630 1700
Fax:
Email: e_razmpoosh@yahoo.com
Web page address:
Name of recruitment center - English: Imam Ali clinic, related to Shahid Sadoughi University of Medical Sciences Name of recruitment center - Persian: کلینیک فوق تخصصی امام علی (ع)، وابسته به دانشگاه علوم پزشکی یزد Name of recruitment center - Persian: Imam Ali clinic, related to Shahid Sadoughi University of Medical Sciences Full name of responsible person - English: آزاده نجارزادهAzadeh Nadjarzadeh Full name of responsible person - Persian: Azadeh Nadjarzadehآزاده نجارزاده Street address - English: Alem Square Street address - Persian: میدان عالم City - English: Yazd City - Persian: یزد Province: Yazd Country: Iran (Islamic Republic of) Postal code: 8915173160 Phone: +98 35 3630 1700 Fax: Email: e_razmpoosh@yahoo.com Web page address:
Sharing plan
Some critical information such as the primary and secondary outcomes as well as the biopsy methods along with the informed consent form and volunteer related forms will be shared.
Some critical information such as the primary and secondary outcomes along with the informed consent form and volunteer related forms will be shared.
Some critical information such as the primary and secondary outcomes as well as the biopsy methods along with the informed consent form and volunteer related forms will be shared.
برخی اطلاعات نظیر پیامد اصلی و فرعی و نحوه گرفتن نمونه بیوپسی به همراه رضایت نامه افراد ، شرکت آگاهانه و شرح کامل پروسه مطالعه برای افراد در دسترس قرار خوهد گرفت.
برخی اطلاعات نظیر پیامد اصلی و فرعی به همراه رضایت نامه افراد ، شرکت آگاهانه و شرح کامل پروسه مطالعه برای افراد در دسترس قرار خوهد گرفت.
برخی اطلاعات نظیر پیامد اصلی و فرعی و نحوه گرفتن نمونه بیوپسی به همراه رضایت نامه افراد ، شرکت آگاهانه و شرح کامل پروسه مطالعه برای افراد در دسترس قرار خوهد گرفت.
Protocol summary
Study aim
Effect of oral black cumin (Nigella Sativa) supplement on the expression of genes involved in adipogenesis and serum concentrations of liver enzymes and lipid profiles among obese and overweight women
Design
This is a cross-over randomized placebo controlled double blind clinical trial.
The target group consisted of 35 women who will randomly assigned into one of the two groups. Duration of the intervention consisted of 2 periods of 2 months;
Settings and conduct
Obese and overweight healthy women who will be referred to Imam Ali hospital in Yazd city, will be recruited and will be randomly divided into 2 groups of supplement and placebo; capsules will be given in a double-blind process; participants and researchers will be blinded to the content. Blood collection will be done to assess the biochemical factors at the beginning and the end of each period; RNA will be extracted from the blood of all participants before and after every intervention in the Internal section of hospital. RTPCR test will be performed on blood samples. After a 1-month washout, all the mentioned procedures will be done for the second period.
Participants/Inclusion and exclusion criteria
Inclusion criteria are healthy obese and overweight women aged 27 to 55 years old with the BMI ranges of 27 to 35 kg/m2; exclusion criteria includes the presence of allergy to the supplements during the intervention period or the use of less than 10% of the supplements.
Intervention groups
the treatment group will receive 2 pearls per day , that each pear contain 1000 ml of nigella sativa for 2 periods of 2 months;
the placebo group will receive 2 pearls per day , that each pear contain 1000 ml of placebo for 2 periods of 2 months;
one month of washout period will be performed between the 2 periods.
Effect of oral balck cumin (Nigella Sativa) supplement on the expression of genes involved in adipogenesis and serum concentrations of liver enzymes and lipid profiles among obese and overweight women
Public title
Effects of nigella satva on obesity related gene changes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Obese women whose overweight and obesity were defined according to WHO criteria.
The BMI range of participants should be between 27 to 35 kg/m2.
Age ranges should be 25 to 55 years old.
Healthy overweight and obese women will be interred to the study.
Exclusion criteria:
Having replacement treatments like Hormone or supplemental vitamins or weight loss drugs;
tobacco and alcohol use
chronic or acute inflammatory disease ; heart valve disease ; short bowel syndrome ; allergies
individuals with low immune system (autoimmune diseases)
pregnancy and lactation
consuming less than 40% of Nigella sativa or placebo supplements.
individuals who had allergy to the nigella sativa supplements.
Age
From 25 years old to 55 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
35
Randomization (investigator's opinion)
Randomized
Randomization description
For the primary recruitment of participants, stratified randomization method will be used based on participants age including 25-40 and 40-55 years old. and the random number table will be used to assign participants to the intervention and control (placebo) groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The appearance and shape of the Supplements and placebos pearls will be similar; every complete packs will be given once for the first 2 months of the intervention and once before the second 2 months of the intervention. A and B labels will be fixed on the bottles of pearls by someone irrelevant to the entire study. Participants and researchers will be blinded to the contents in the bottles through out the study.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Faculty of Health, Shahid Sadoughi University of Medical Sciences
Street address
Alem Sauare
City
Yazd
Province
Yazd
Postal code
8915173160
Approval date
2018-04-17, 1397/01/28
Ethics committee reference number
IR.SSU.SPH.REC.1397.007
Health conditions studied
1
Description of health condition studied
Obesity and overweight
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified
Primary outcomes
1
Description
Alteration in adipogenesis related gene sequence
Timepoint
Four times; at the beginning and the end of the first 2-month trial and at beginning and the end of the second 2-month trial
Method of measurement
centrifuge
2
Description
Liver enzyme, alanine aminotransferase (ALT)
Timepoint
4 times; at the initiation and the end of the first 2-month trial and at the initiation and the end of the second 2-month trial
Method of measurement
Assay Kits (Pars Azmoon Co.)
3
Description
Lipid profile
Timepoint
4 times; at the initiation and the end of the first 2-month trial and at the initiation and the end of the second 2-month trial
Method of measurement
Assay kits (Padgin Teb Co.)
4
Description
Liver enzyme, Aspartate aminotransferase
Timepoint
4 times; at the initiation and the end of the first 2-month trial and at the initiation and the end of the second 2-month trial
Method of measurement
Assay Kits (Pars Azmoon Co.)
5
Description
Liver enzyme, Alkaline phosphatase (ALK)
Timepoint
4 times; at the initiation and the end of the first 2-month trial and at the initiation and the end of the second 2-month trial
Method of measurement
Assay Kits (Pars Azmoon Co.)
Secondary outcomes
1
Description
Blood Pressure
Timepoint
4 times; at the initiation and the end of the first 2-month trial and at the initiation and the end of the second 2-month trial
Method of measurement
Mercury barometer
2
Description
anthropometric measurments
Timepoint
4 times; at the initiation and the end of the first 2-month trial and at the initiation and the end of the second 2-month trial
Method of measurement
digital anthropometric scale
Intervention groups
1
Description
Intervention group: the treatment group will receive 2 pearls of Nigella sativa per day after lunch and dinner, that each pearl contain 1000 ml of nigella sativa for 2 periods of 2 months; the pearls are produced by Barij Co.
Category
Treatment - Other
2
Description
Control group: the placebo group will receive 2 pearls per day , that each pear contain 1000 ml of placebo for 2 periods of 2 months; one month of washout period will be performed between the 2 periods. placebo will be the oral paraffin.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali clinic, related to Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Azadeh Nadjarzadeh
Street address
Alem Square
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3630 1700
Email
e_razmpoosh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Azadeh Nadjarzadeh
Street address
Alem Square
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
azadehnajarzadeh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
50
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
Yazd University of Medical Sciences
Full name of responsible person
Azadeh Nadjarzadeh
Position
assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Alem Square
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
azadehnajarzadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Azadeh Nadjarzadeh
Position
assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Alem Square
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
azadehnajarzadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Azadeh Nadjarzadeh
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Alem Square- Pardis- faculty of Health
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9101
Email
azadehnajarzadeh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Some critical information such as the primary and secondary outcomes along with the informed consent form and volunteer related forms will be shared.
When the data will become available and for how long
6 months after the publication of the first related article
To whom data/document is available
Assistant professors and researchers, giving their detailed information and the reason for achieving the information.
Under which criteria data/document could be used
the permission from the correspondence
From where data/document is obtainable
Nutrition group, Faculty of Health, Shahid Sadoughi University of Medical Sciences
What processes are involved for a request to access data/document
discussing the request in Nutrition group and waiting for their assessment on the request