Evaluation of efficacy of intra articular injection of mannitol versus hypertonic dextrose prolotherapy on decreasing pain and improvement of functions in patients with knee osteoarthritis
Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
Protocol summary
بررسی اثر تزریق داخل مفصلی مانیتول در مقایسه با دکستروز هیپر تونیک به روش پورلوتراپی در کاهش درد وبهبود عملکردبیماران مبتلا به استئوارتریت زانو
بررسی اثر تزریق داخل مفصلی مانیتول در مقایسه با دکستروز هیپر تونیک به روش پرولوتراپی در کاهش درد وبهبود عملکردبیماران مبتلا به استئوارتریت زانو
بررسی اثر تزریق داخل مفصلی مانیتول در مقایسه با دکستروز هیپر تونیک به روش پورلوتراپیپرولوتراپی در کاهش درد وبهبود عملکردبیماران مبتلا به استئوارتریت زانو
The research is a randomize triple blind clinical trial
This research is a randomized double-blind, controlled clinical trial
TheThis research is a randomize triple randomized double-blind, controlled clinical trial
مطالعه یک کار آزمایی بالینی تصادفی سازی شده سه سو کور همراه با گروه کنترل میباشد.
مطالعه یک کار آزمایی بالینی تصادفی سازی شده دوسوکور همراه با گروه کنترل میباشد.
مطالعه یک کار آزمایی بالینی تصادفی سازی شده سه سو کوردوسوکور همراه با گروه کنترل میباشد.
Inclusion criteria :age : 38 to75 years old
Gender: male or female
Knee radiography anterior standing view have been for the last one month
Have symptoms of osteoarthritis include pain, crepitation and knee joint dryness for at least a month without any extra articular involvement .Any injection of the knee joint during the last three of months
Exclusion criteria: sensitivity reaction to test drug
The patient have done total knee arthroplasty
The patient have diseases mimicking the symptoms of knee pain such as neuropathy and radiculopathy
Diseases such as rheumatoid arthritis, Reiter's syndrom, gout
Uncontrolled diabetes,HBA1c more than7.5, BMI more than 40
History of knee trauma,fracture
Patient's mental disorder
Inclusion criteria: aged 38 to75 years; both genders; knee radiography anterior standing view have been for the last one month; have symptoms of osteoarthritis include pain, crepitation, and knee joint dryness for at least a month without any extra-articular involvement; any injection of the knee joint during the last three of months.
Exclusion criteria: sensitivity reaction to test drug; the patient has done total knee arthroplasty; the patient have diseases mimicking the symptoms of knee pain such as neuropathy and radiculopathy; diseases such as rheumatoid arthritis, Reiter's syndrome, gout; uncontrolled diabetes, HBA1c more than7.5, BMI more than 40; history of knee trauma, fracture
patient's mental disorder.
Inclusion criteria:age : aged 38 to75 years old Gender: male or female Knee; both genders; knee radiography anterior standing view have been for the last one month Have; have symptoms of osteoarthritis include pain, crepitation, and knee joint dryness for at least a month without any extra-articular involvement .Any; any injection of the knee joint during the last three of months. Exclusion criteria: sensitivity reaction to test drug The; the patient havehas done total knee arthroplasty The; the patient have diseases mimicking the symptoms of knee pain such as neuropathy and radiculopathy Diseases; diseases such as rheumatoid arthritis, Reiter's syndromsyndrome, gout Uncontrolled diabetes,HBA1c; uncontrolled diabetes, HBA1c more than7.5, BMI more than 40 History; history of knee trauma,fracture Patient'strauma, fracture patient's mental disorder.
General information
1
1
1
1
misspelling
wrong translation
misspellingwrong translation
غلط املایی
اشتباه ترجمه
غلط املاییاشتباه ترجمه
بررسی اثر تزریق داخل مفصلی مانیتول در مقایسه با دکستروز هیپر تونیک به روش پورلو تراپی در کاهش درد و بهبود عملکرد بیماران مبتلا به استئو ارتریت زانو
بررسی اثر تزریق داخل مفصلی مانیتول در مقایسه با دکستروز هیپر تونیک به روش پرولوتراپی در کاهش درد و بهبود عملکرد بیماران مبتلا به استئو ارتریت زانو
بررسی اثر تزریق داخل مفصلی مانیتول در مقایسه با دکستروز هیپر تونیک به روش پورلو تراپیپرولوتراپی در کاهش درد و بهبود عملکرد بیماران مبتلا به استئو ارتریت زانو
هرگونه تزریق داخل مفصل زانو در سه ماه گذشته
واکنش حساسیت به داروی مورد آزمایش
وانکبیماری که آرتروپلاستی کامل زانو انجام داده باشد
وجود بیماریهایی که علایم درد زانو را تقلید میکنند مثل نوروپاتی و رادیکولو پاتی
وجود بیماریهایی چون روماتیسم مفصلی، سندروم رایترز و نقرس
دیابت کنترل نشده، هموگلوبین گلوکوزیله بالای ۷/۵واندکس توده بدنی بیشتر از ۴۰
سابقه تروما به زانو و شکستگی
اختلالات شعوری بیمار
هرگونه تزریق داخل مفصل زانو در سه ماه گذشته
واکنش حساسیت به داروی مورد آزمایش
بیماری که آرتروپلاستی کامل زانو انجام داده باشد
وجود بیماریهایی که علایم درد زانو را تقلید میکنند مثل نوروپاتی و رادیکولو پاتی
وجود بیماریهایی چون روماتیسم مفصلی، سندروم رایترز و نقرس
دیابت کنترل نشده، هموگلوبین گلوکوزیله بالای ۷/۵واندکس توده بدنی بیشتر از ۴۰
سابقه تروما به زانو و شکستگی
اختلالات شعوری بیمار
هرگونه تزریق داخل مفصل زانو در سه ماه گذشته واکنش حساسیت به داروی مورد آزمایش وانکبیماریبیماری که آرتروپلاستی کامل زانو انجام داده باشد وجود بیماریهایی که علایم درد زانو را تقلید میکنند مثل نوروپاتی و رادیکولو پاتی وجود بیماریهایی چون روماتیسم مفصلی، سندروم رایترز و نقرس دیابت کنترل نشده، هموگلوبین گلوکوزیله بالای ۷/۵واندکس توده بدنی بیشتر از ۴۰ سابقه تروما به زانو و شکستگی اختلالات شعوری بیمار
Intervention groups
#1
Intervention group: the group that receive 5cc mannitol, knee intra articular injection ,in three doses as the first dose and two weeks, four weeks , weeks after first dose and control group that receive 5cc of dextrose 25%,inter articular injection,as sequence of intervention group.
Intervention group: the group that receive 5cc mannitol 5%, knee intra articular injection ,in three doses as the first dose and two weeks, four weeks , weeks after first dose and control group that receive 5cc of dextrose 25%,inter articular injection,as sequence of intervention group.
Intervention group: the group that receive 5cc mannitol 5%, knee intra articular injection ,in three doses as the first dose and two weeks, four weeks , weeks after first dose and control group that receive 5cc of dextrose 25%,inter articular injection,as sequence of intervention group.
گروه مداخله: گروهی که ۵ میلی لیترداروی مانیتول ۷درصد رادر چهار نوبت بصورت نوبت اول ،۲ هفته بعد،۴ هفته بعد از نوبت اول به صورت داخل مفصلی زانو دریافت کرده اند. و گروه کنترل:گروهی که ۵ میلی لیتر داروی دکستروز ۲۵ درصد را به صورت داخل مفصل زانو با همان توالی زمانی گروه مداخله دریافت میکنند.
گروه مداخله: گروهی که ۵ میلی لیترداروی مانیتول 5درصد رادر سه نوبت بصورت نوبت اول ،۲ هفته بعد،۴ هفته بعد از نوبت اول به صورت داخل مفصلی زانو دریافت کرده اند. و گروه کنترل:گروهی که ۵ میلی لیتر داروی دکستروز ۲۵ درصد را به صورت داخل مفصل زانو با همان توالی زمانی گروه مداخله دریافت میکنند.
گروه مداخله: گروهی که ۵ میلی لیترداروی مانیتول ۷درصد5درصد رادر چهارسه نوبت بصورت نوبت اول ،۲ هفته بعد،۴ هفته بعد از نوبت اول به صورت داخل مفصلی زانو دریافت کرده اند. و گروه کنترل:گروهی که ۵ میلی لیتر داروی دکستروز ۲۵ درصد را به صورت داخل مفصل زانو با همان توالی زمانی گروه مداخله دریافت میکنند.
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Nasrin barzegar
Full name of responsible person - Persian: نسرین برزگر
Position - English: Resident
Position - Persian: فارسی
Latest degree: med_doctor
Area of specialty/work: 59
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No.11 , Ansar Ave., koohbor Blvd., Zerehi
Street address - Persian: زرهی، بلوار کوهبر، خیابان انصار 11
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 7184747811
Phone: +98 71 3648 6787
Mobile: +98 917 309 2357
Fax:
Email: Dr.nasrin.barzegar1975@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Nasrin Barzegar
Full name of responsible person - Persian: نسرین برزگر
Position - English: Resident
Position - Persian: فارسی
Latest degree: med_doctor
Area of specialty/work: 59
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No.11 , Ansar Ave., koohbor Blvd., Zerehi
Street address - Persian: زرهی، بلوار کوهبر، خیابان انصار 11
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 7184747811
Phone: +98 71 3648 6787
Mobile: +98 917 309 2357
Fax:
Email: Dr.nasrin.barzegar1975@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Nasrin barzegarBarzegar Full name of responsible person - Persian: نسرین برزگر Position - English: Resident Position - Persian: فارسی Latest degree: med_doctor Area of specialty/work: 59 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: No.11 , Ansar Ave., koohbor Blvd., Zerehi Street address - Persian: زرهی، بلوار کوهبر، خیابان انصار 11 City - English: Shiraz City - Persian: شیراز Province: Fars Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 7184747811 Phone: +98 71 3648 6787 Mobile: +98 917 309 2357 Fax: Email: Dr.nasrin.barzegar1975@gmail.com Web page address:
Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Nasrin barzegar
Full name of responsible person - Persian: نسرین برزگر
Position - English: Resident
Position - Persian: رزیدنت
Latest degree: med_doctor
Area of specialty/work: 59
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No.11., Ansar Avn., koohbor Blvd., Zerehi
Street address - Persian: زرهی، بلوار کوهبر، خیابان انصار 11
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 7184747811
Phone: 00986486787
Mobile: +98 917 309 2357
Fax:
Email: Dr.nasrin.barzegar1975@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Nasrin Barzegar
Full name of responsible person - Persian: نسرین برزگر
Position - English: Resident
Position - Persian: رزیدنت
Latest degree: med_doctor
Area of specialty/work: 59
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No.11., Ansar Avn., koohbor Blvd., Zerehi
Street address - Persian: زرهی، بلوار کوهبر، خیابان انصار 11
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 7184747811
Phone: 00986486787
Mobile: +98 917 309 2357
Fax:
Email: Dr.nasrin.barzegar1975@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Nasrin barzegarBarzegar Full name of responsible person - Persian: نسرین برزگر Position - English: Resident Position - Persian: رزیدنت Latest degree: med_doctor Area of specialty/work: 59 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: No.11., Ansar Avn., koohbor Blvd., Zerehi Street address - Persian: زرهی، بلوار کوهبر، خیابان انصار 11 City - English: Shiraz City - Persian: شیراز Province: Fars Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 7184747811 Phone: 00986486787 Mobile: +98 917 309 2357 Fax: Email: Dr.nasrin.barzegar1975@gmail.com Web page address:
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Nasrin barzegar
Full name of responsible person - Persian: نسرین برزگر
Position - English: Resident
Position - Persian: رزیدنت
Latest degree: med_doctor
Area of specialty/work: 59
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No11., AnsarAve ., koohbor Blvd., Zerehi
Street address - Persian: زرهی، بلوار کوهبر، خیابان انصار11
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 7184747811
Phone: +98 71 3648 6787
Mobile: +98 917 309 2357
Fax:
Email: Dr.nasrin.barzegar1975@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Nasrin Barzegar
Full name of responsible person - Persian: نسرین برزگر
Position - English: Resident
Position - Persian: رزیدنت
Latest degree: med_doctor
Area of specialty/work: 59
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No11., AnsarAve ., koohbor Blvd., Zerehi
Street address - Persian: زرهی، بلوار کوهبر، خیابان انصار11
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 7184747811
Phone: +98 71 3648 6787
Mobile: +98 917 309 2357
Fax:
Email: Dr.nasrin.barzegar1975@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Nasrin barzegarBarzegar Full name of responsible person - Persian: نسرین برزگر Position - English: Resident Position - Persian: رزیدنت Latest degree: med_doctor Area of specialty/work: 59 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: No11., AnsarAve ., koohbor Blvd., Zerehi Street address - Persian: زرهی، بلوار کوهبر، خیابان انصار11 City - English: Shiraz City - Persian: شیراز Province: Fars Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 7184747811 Phone: +98 71 3648 6787 Mobile: +98 917 309 2357 Fax: Email: Dr.nasrin.barzegar1975@gmail.com Web page address:
Protocol summary
Study aim
Evaluation of efficacy of intra articular injection of mannitol versus hypertonic dextrose prolothrapy on decreasing pain and improvement of function in patients with knee osteoarthritis randomize clinical trial
Design
This research is a randomized double-blind, controlled clinical trial
Settings and conduct
The patient select from emam reza clinic and rajaee hospital who has knee osteoarthritis.then patient divided into two groups and after obtaining written consent the study begins. in control group hypertonic dextrose is injected and in intervention group monitol is injected then we measure its effect on reducing pain and improving patient function
Participants/Inclusion and exclusion criteria
Inclusion criteria: aged 38 to75 years; both genders; knee radiography anterior standing view have been for the last one month; have symptoms of osteoarthritis include pain, crepitation, and knee joint dryness for at least a month without any extra-articular involvement; any injection of the knee joint during the last three of months.
Exclusion criteria: sensitivity reaction to test drug; the patient has done total knee arthroplasty; the patient have diseases mimicking the symptoms of knee pain such as neuropathy and radiculopathy; diseases such as rheumatoid arthritis, Reiter's syndrome, gout; uncontrolled diabetes, HBA1c more than7.5, BMI more than 40; history of knee trauma, fracture
patient's mental disorder.
Intervention groups
Intervention group:group that receive knee intra articular injection of mannitol
control group: group that receive knee intra articular injection of hypertonic Dextrose.
Main outcome variables
pain, Activity of daily living
General information
Reason for update
wrong translation
Acronym
IRCT registration information
IRCT registration number:IRCT20190912044756N1
Registration date:2020-08-24, 1399/06/03
Registration timing:registered_while_recruiting
Last update:2022-02-13, 1400/11/24
Update count:2
Registration date
2020-08-24, 1399/06/03
Registrant information
Name
Nasrin Barzegar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3648 6787
Email address
dr.nasrin.barzegar1975@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-20, 1399/02/31
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy of intra articular injection of mannitol versus hypertonic dextrose prolotherapy on decreasing pain and improvement of functions in patients with knee osteoarthritis
Public title
Evaluation of efficacy of intra articular injection of mannitol in patient with knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age: 38 to70 years old
Gender: male or female
Knee radiography anterior standing view have been for the last three month
Have symptoms of osteoartritis include pain, crepitation for at least a month without any extra articular involvment
Exclusion criteria:
Any injection of the knee joint during the last three of months
sensitivity reaction to test drug
The patient have done total knee arthroplasty
The patient have diseases mimicking the symptoms of knee pain such as neuropathy and radiculopathy
Diseases such as rheumatoid arthritis, Reiter's syndrom, gout
Uncontrolled diabetes,HBA1c more than7.5, BMI more than 40
History of knee trauma,fracture
Patient's mental disorder
Age
From 38 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
2
If both knee are involve,one kneeis in the intervention group and the other is in the control group
Randomization (investigator's opinion)
Randomized
Randomization description
Complete randomize block design with SSPP software is used for randomization and then sealed non-transparent envelopes are used to hide the random sequence
Blinding (investigator's opinion)
Double blinded
Blinding description
Participant: The participant is explained that if they are interested, they can
join our research project. two methods used to reduce patient pain input study are explained to the patient. Benefits and possible complications of both methods are described to the patient and the patient is told to randomly fall into one of the intervention groups. If the patient is accepted to admit the study, by random allocation soft ware, the patient falls in to one of two groups.
Clinical car giver: we teach the caregiver how to complete the questionnaier. This person is not aware of receiving patient intervention.
Researcher: In this study does not have the ability to blind the reseacher because the researcher performs both intervention himself and is aware of receiving each intervention in the group.
The outcome assessor of the complete questionnaires is given to person who is not aware of the interventions performed and he/she is asked to determine the level of performance in each person according to the questionnaires.
Date analyzer: questionnaire are finally given to a person to review the information. This person doesn't know any of the steps of the work, how to classify and the intervention performed.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz School of Medicin
Street address
No.11, Ansar Ave., Koohbor Blvd., Zerehi
City
Shiraz
Province
Fars
Postal code
7184747811
Approval date
2019-07-28, 1398/05/06
Ethics committee reference number
IR.SUMS.MED.REC.1398.314
Health conditions studied
1
Description of health condition studied
Osteoarthritis of knee
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
knee pain
Timepoint
Two weeks ,foure weeks, eight weeks
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Function of patient
Timepoint
two weeks, four weeks, eight weeks
Method of measurement
Oxford knee score
Intervention groups
1
Description
Intervention group: the group that receive 5cc mannitol 5%, knee intra articular injection ,in three doses as the first dose and two weeks, four weeks , weeks after first dose and control group that receive 5cc of dextrose 25%,inter articular injection,as sequence of intervention group.
Category
Rehabilitation
2
Description
Control group: group who received knee intra articular injection of hypertonic dextrose
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam reza rehabilitation clinic
Full name of responsible person
Mani Ramzi
Street address
Namazi square
City
Shiraz
Province
Fars
Postal code
714737-71348
Phone
+98 71 3212 7000
Email
motahari@sums.ac.ir
Web page address
2
Recruitment center
Name of recruitment center
Rajaee haspital
Full name of responsible person
Amir Reza mesbahi
Street address
Chamran Blvd
City
Shiraz
Province
Fars
Postal code
7194815711
Phone
+98 71 3636 4001
Fax
Email
Rajaeehospital@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr ghasemi
Street address
Khalili Aveno,front of maaref school
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3628 1506
Email
Info@sums.ac.i
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
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
Shiraz University of Medical Sciences
Full name of responsible person
Nasrin Barzegar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
No.11 , Ansar Ave., koohbor Blvd., Zerehi
City
Shiraz
Province
Fars
Postal code
7184747811
Phone
+98 71 3648 6787
Email
Dr.nasrin.barzegar1975@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nasrin Barzegar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
No.11., Ansar Avn., koohbor Blvd., Zerehi
City
Shiraz
Province
Fars
Postal code
7184747811
Phone
00986486787
Email
Dr.nasrin.barzegar1975@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nasrin Barzegar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
No11., AnsarAve ., koohbor Blvd., Zerehi
City
Shiraz
Province
Fars
Postal code
7184747811
Phone
+98 71 3648 6787
Email
Dr.nasrin.barzegar1975@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
All available data can be shared after making people unidentifiable.
When the data will become available and for how long
Start access period one year after publishing the results.
To whom data/document is available
everyone can access to this information.
Under which criteria data/document could be used
if the information in this study helps to improve the science process.
From where data/document is obtainable
dr.nasrin.barzegar1975@gmail.com 00989173092357
What processes are involved for a request to access data/document
After sending the desired message, all authors of the study will be consulted all information will be sent within a maximum of three weeks if permitted.