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
The aim of the present study is to investigate the effect of Q10 on laboratory findings in thalassemia patients treated with deferasirox.
The aim of the present study is to investigate the effect of Q10 on laboratory findings in thalassemia patients treated with Iron chelators.
The aim of the present study is to investigate the effect of Q10 on laboratory findings in thalassemia patients treated with deferasiroxIron chelators.
هدف از مطالعه حاضر بررسی اثر کیوتن بر یافته های آزمایشگاهی در بیماران تالاسمی تحت درمان با دفراسیروکس میباشد.
هدف از مطالعه حاضر بررسی اثر کیوتن بر یافته های آزمایشگاهی در بیماران تالاسمی تحت درمان با داروهای شلاتعه کننده آهن یباشد.
هدف از مطالعه حاضر بررسی اثر کیوتن بر یافته های آزمایشگاهی در بیماران تالاسمی تحت درمان با دفراسیروکس میداروهای شلاتعه کننده آهن یباشد.
Patients with major and intermedia beta-thalassemia disease; patients who have had a history of taking Deferasirox regularly in the past three months, if they wish to cooperate (consent form will be completed by the parents of the patients for children under 18 years old and the patients themselves for patients over 18 years old).
Patients with major and intermedia beta-thalassemia disease; patients who have had a history of taking Iron chelators regularly in the past three months, if they wish to cooperate (consent form will be completed by the parents of the patients for children under 18 years old and the patients themselves for patients over 18 years old).
Patients with major and intermedia beta-thalassemia disease; patients who have had a history of taking DeferasiroxIron chelators regularly in the past three months, if they wish to cooperate (consent form will be completed by the parents of the patients for children under 18 years old and the patients themselves for patients over 18 years old).
بیماران مبتلا به بیماری بتا تالاسمی ماژور و اینترمدیا، بیمارانی که در سه ماه گذشته سابقه مصرف دفراسیروکس بطور منظم داشته اند، در صورت تمایل به همکاری (فرم رضایت نامه توسط والدین بیماران برای کودکان زیر 18 سال و خود بیماران در بیماران بالای 18 سال).
بیماران مبتلا به بیماری بتا تالاسمی ماژور و اینترمدیا، بیمارانی که در سه ماه گذشته سابقه مصرف داروهای شلاته کننده آهن بطور منظم داشته اند، در صورت تمایل به همکاری (فرم رضایت نامه توسط والدین بیماران برای کودکان زیر 18 سال و خود بیماران در بیماران بالای 18 سال).
بیماران مبتلا به بیماری بتا تالاسمی ماژور و اینترمدیا، بیمارانی که در سه ماه گذشته سابقه مصرف دفراسیروکسداروهای شلاته کننده آهن بطور منظم داشته اند، در صورت تمایل به همکاری (فرم رضایت نامه توسط والدین بیماران برای کودکان زیر 18 سال و خود بیماران در بیماران بالای 18 سال).
Group 1) 100 mg of ketones will be given daily for 3 months to thalassemia patients treated with Deferasirox.
Group 2) Placebo pill (100mg) which does not contain an interfering agent, was given daily for 3 months to thalassemia patients treated with Deferasirox will be given.
Group 1) 100 mg of ketones will be given daily for 3 months to thalassemia patients treated with Iron chelators.
Group 2) Placebo pill (100mg) which does not contain an interfering agent, was given daily for 3 months to thalassemia patients treated with Iron chelators will be given.
Group 1) 100 mg of ketones will be given daily for 3 months to thalassemia patients treated with DeferasiroxIron chelators. Group 2) Placebo pill (100mg) which does not contain an interfering agent, was given daily for 3 months to thalassemia patients treated with DeferasiroxIron chelators will be given.
گروه 1) 100 میلیگرم کیوتن روزانه به مدت 3 ماه به بیماران تالاسمی تحت درمان با دفراسیروکس این گروه داده خواهد شد.
گروه 2)قرص پلاسبو (100 میلی گرم) که فاقد عامل مداخله گر است روزانه به مدت 3 ماه به بیماران تالاسمی تحت درمان با دفراسیروکس، داده خواهد شد.
گروه 1) 100 میلیگرم کیوتن روزانه به مدت 3 ماه به بیماران تالاسمی تحت درمان با داروهای شلاته کننده آهن این گروه داده خواهد شد.
گروه 2)قرص پلاسبو (100 میلی گرم) که فاقد عامل مداخله گر است روزانه به مدت 3 ماه به بیماران تالاسمی تحت درمان با داروهای شلاته کننده آهن، داده خواهد شد.
گروه 1) 100 میلیگرم کیوتن روزانه به مدت 3 ماه به بیماران تالاسمی تحت درمان با دفراسیروکسداروهای شلاته کننده آهن این گروه داده خواهد شد. گروه 2)قرص پلاسبو (100 میلی گرم) که فاقد عامل مداخله گر است روزانه به مدت 3 ماه به بیماران تالاسمی تحت درمان با دفراسیروکسداروهای شلاته کننده آهن، داده خواهد شد.
General information
4
3
43
Due to the fact that most adult thalassemia patients take multiple drugs at the same time and most children take only one medication, we reduced the age of entering the study.
Kiton medicine is not contraindicated for people over one year of age.
Due to the fact that most thalassemia patients take several drugs at the same time, we decided to investigate different drugs so that more people are included in the study and different patients are investigated.
Due to the fact that most adult thalassemia patients take multipleseveral drugs at the same time and most children take only one medication, we reduced the age of enteringdecided to investigate different drugs so that more people are included in the study and different patients are investigated. Kiton medicine is not contraindicated for people over one year of age.
با توجه به اینکه اکثر بیماران تالاسمی بزرگسالان چندین دارو را به طور همزمان مصرف می کنند و اکثر کودکان فقط یک دارو مصرف می کنند، سن ورود به مطالعه را کاهش دادیم.
داروی کیتون برای افراد بالای یک سال منع مصرف ندارد.
با توجه به اینکه اکثر بیماران تالاسمی چندین دارو را به طور همزمان مصرف می کنند ما تصمیم گرفتیم ییماران مختلفی را مورد بررسی قرار دهیم تا تعداد افراد بیشتری وارد مطالعه شوند و بیماران مختلفی مورد بررسی قرار گیرند.
با توجه به اینکه اکثر بیماران تالاسمی بزرگسالان چندین دارو را به طور همزمان مصرف می کنند و اکثر کودکان فقط یک دارو مصرف می کنند، سن ورود بهما تصمیم گرفتیم ییماران مختلفی را مورد بررسی قرار دهیم تا تعداد افراد بیشتری وارد مطالعه را کاهش دادیمشوند و بیماران مختلفی مورد بررسی قرار گیرند. داروی کیتون برای افراد بالای یک سال منع مصرف ندارد.
Investigating the effect of Q10 in thalassemia patients treated with deferasirox
Investigating the effect of Q10 in thalassemia patients treated with Iron chelators
Investigating the effect of Q10 in thalassemia patients treated with deferasiroxIron chelators
بررسی تاثیر کیوتن در بیماران تالاسمی تحت درمان با دفراسیروکس
بررسی تاثیر کیوتن در بیماران تالاسمی تحت درمان با شلاته کننده های آهن
بررسی تاثیر کیوتن در بیماران تالاسمی تحت درمان با دفراسیروکسشلاته کننده های آهن
Investigating the effect of Q10 on laboratory findings in thalassemia patients treated with deferasirox: a double-blind clinical trial
Investigating the effect of Q10 on laboratory findings in thalassemia patients treated with Iron chelators: a double-blind clinical trial
Investigating the effect of Q10 on laboratory findings in thalassemia patients treated with deferasiroxIron chelators: a double-blind clinical trial
بررسی تاثیر کیوتن بر یافته های آزمایشگاهی در بیماران تالاسمی تحت درمان با دفراسیروکس: کارآزمایی بالینی دو سو کور
بررسی تاثیر کیوتن بر یافته های آزمایشگاهی در بیماران تالاسمی تحت درمان با شلاته کننده های آهن: کارآزمایی بالینی دو سو کور
بررسی تاثیر کیوتن بر یافته های آزمایشگاهی در بیماران تالاسمی تحت درمان با دفراسیروکسشلاته کننده های آهن: کارآزمایی بالینی دو سو کور
Patients with major and intermedia beta thalassemia disease
History of taking Defrasirox regularly in the last three months
Age between 2 and 65 years
Patients with major and intermedia beta thalassemia disease
History of taking Iron chelators regularly in the last three months
Age between 2 and 65 years
Patients with major and intermedia beta thalassemia disease History of taking DefrasiroxIron chelators regularly in the last three months Age between 2 and 65 years
بیماران مبتلا به بیماری بتا تالاسمی ماژور و اینترمدیا
سابقه مصرف دفراسیروکس به طور منظم در سه ماه گذشته
سن بین 2 تا 65 سال
بیماران مبتلا به بیماری بتا تالاسمی ماژور و اینترمدیا
سابقه مصرف شلاته کننده های آهن به طور منظم در سه ماه گذشته
سن بین 2 تا 65 سال
بیماران مبتلا به بیماری بتا تالاسمی ماژور و اینترمدیا سابقه مصرف دفراسیروکسشلاته کننده های آهن به طور منظم در سه ماه گذشته سن بین 2 تا 65 سال
Health conditions studied
#1
thalassemia
Thalassemia
thalassemiaThalassemia
Primary outcomes
#1
GFR
Glomerular filtration rate
GFRGlomerular filtration rate
تعیین میزان اثربخشی مداخله پس از درمان برحسب تغییرات GFR
تعیین میزان اثربخشی مداخله پس از درمان برحسب تغییرات میزان فیلتراسیون گلومرولی
تعیین میزان اثربخشی مداخله پس از درمان برحسب تغییرات GFRمیزان فیلتراسیون گلومرولی
#2
BUN
Blood Urea Nitrogen
BUNBlood Urea Nitrogen
تعیین میزان اثربخشی مداخله پس از درمان برحسب تغییرات BUN
تعیین میزان اثربخشی مداخله پس از درمان برحسب تغییرات نیتروژن اوره خون
تعیین میزان اثربخشی مداخله پس از درمان برحسب تغییرات BUNنیتروژن اوره خون
Intervention group: Receiving 100 mg of Q10 tablets daily for 3 months to thalassemia patients treated with deferasirox
Intervention group: Receiving 100 mg of Q10 tablets (Provided by Shari Pharmaceutical Company) daily for 3 months to thalassemia patients treated with Iron chelators
Intervention group: Receiving 100 mg of Q10 tablets (Provided by Shari Pharmaceutical Company) daily for 3 months to thalassemia patients treated with deferasiroxIron chelators
گروه مداخله: دریافت 100 میلی گرم قرص Q10 روزانه به مدت 3 ماه در بیماران تالاسمی تحت درمان با دفراسیروکس
گروه مداخله: دریافت 100 میلی گرم قرص Q10 (تهیه شده از شرکت داروسازی شاری) روزانه به مدت 3 ماه در بیماران تالاسمی تحت درمان با شلاته کننده های آهن
گروه مداخله: دریافت 100 میلی گرم قرص Q10 (تهیه شده از شرکت داروسازی شاری) روزانه به مدت 3 ماه در بیماران تالاسمی تحت درمان با دفراسیروکسشلاته کننده های آهن
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr Malihe Mohamadzade
Full name of responsible person - Persian: دکتر ملیحه محمدزاده
Position - English: Assistant Professor
Position - Persian: استادیار
Latest degree: sub_specialist
Area of specialty/work: 39
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Educational and Research Complex of the Great Prophet , Shahid Mohammadi Hospital, Jomhory Blvd, Old Airport, Bandar Abbas, Iran
Street address - Persian: بندرعباس، فرودگاه قدیم، بلوار جمهوری، مجتمع آموزشی و پژوهشی پیامبر اعظم، بیمارستان شهید محمدی
City - English: Bandarabbas
City - Persian: بندرعباس
Province: Hormozgan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 79151
Phone: +98 76 3371 0373
Mobile: +98 917 767 4210
Fax:
Email: mohammadzadeh_aa@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr Malihe Mohamadzade
Full name of responsible person - Persian: دکتر ملیحه محمدزاده
Position - English: Assistant Professor
Position - Persian: استادیار
Latest degree: sub_specialist
Area of specialty/work: 39
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Educational and Research Complex of the Great Prophet , Shahid Mohammadi Hospital, Jomhory Blvd, Old Airport, Bandar Abbas, Iran
Street address - Persian: بندرعباس، فرودگاه قدیم، بلوار جمهوری، مجتمع آموزشی و پژوهشی پیامبر اعظم، بیمارستان شهید محمدی
City - English: Bandarabbas
City - Persian: بندرعباس
Province: Hormozgan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 7919915519
Phone: +98 76 3371 0373
Mobile: +98 917 767 4210
Fax:
Email: mohammadzadeh_aa@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr Malihe Mohamadzade Full name of responsible person - Persian: دکتر ملیحه محمدزاده Position - English: Assistant Professor Position - Persian: استادیار Latest degree: sub_specialist Area of specialty/work: 39 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Educational and Research Complex of the Great Prophet , Shahid Mohammadi Hospital, Jomhory Blvd, Old Airport, Bandar Abbas, Iran Street address - Persian: بندرعباس، فرودگاه قدیم، بلوار جمهوری، مجتمع آموزشی و پژوهشی پیامبر اعظم، بیمارستان شهید محمدی City - English: Bandarabbas City - Persian: بندرعباس Province: Hormozgan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 791517919915519 Phone: +98 76 3371 0373 Mobile: +98 917 767 4210 Fax: Email: mohammadzadeh_aa@yahoo.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: Dr Parvin Kamkar
Full name of responsible person - Persian: دکتر پروین کامکار
Position - English: Associate professor
Position - Persian: استادیار
Latest degree: specialist
Area of specialty/work:
Area of specialty/work title - English: Nephrology
Area of specialty/work title - Persian: نفرولوژی
Street address - English: Educational and Research Complex of the Great Prophet , Shahid Mohammadi Hospital, Jomhory Blvd, Old Airport, Bandar Abbas, Iran
Street address - Persian: بندرعباس، فرودگاه قدیم، بلوار جمهوری، مجتمع آموزشی و پژوهشی پیامبر اعظم، بیمارستان شهید محمدی
City - English: BandarAbbas
City - Persian: بندرعباس
Province: Hormozgan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 79151
Phone: +98 76 3334 7000
Mobile: +98 917 308 5779
Fax:
Email: Pkamkar10@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr Parvin Kamkar
Full name of responsible person - Persian: دکتر پروین کامکار
Position - English: Associate professor
Position - Persian: استادیار
Latest degree: specialist
Area of specialty/work:
Area of specialty/work title - English: Nephrology
Area of specialty/work title - Persian: نفرولوژی
Street address - English: Educational and Research Complex of the Great Prophet , Shahid Mohammadi Hospital, Jomhory Blvd, Old Airport, Bandar Abbas, Iran
Street address - Persian: بندرعباس، فرودگاه قدیم، بلوار جمهوری، مجتمع آموزشی و پژوهشی پیامبر اعظم، بیمارستان شهید محمدی
City - English: BandarAbbas
City - Persian: بندرعباس
Province: Hormozgan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 7919915519
Phone: +98 76 3334 7000
Mobile: +98 917 308 5779
Fax:
Email: Pkamkar10@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr Parvin Kamkar Full name of responsible person - Persian: دکتر پروین کامکار Position - English: Associate professor Position - Persian: استادیار Latest degree: specialist Area of specialty/work: Area of specialty/work title - English: Nephrology Area of specialty/work title - Persian: نفرولوژی Street address - English: Educational and Research Complex of the Great Prophet , Shahid Mohammadi Hospital, Jomhory Blvd, Old Airport, Bandar Abbas, Iran Street address - Persian: بندرعباس، فرودگاه قدیم، بلوار جمهوری، مجتمع آموزشی و پژوهشی پیامبر اعظم، بیمارستان شهید محمدی City - English: BandarAbbas City - Persian: بندرعباس Province: Hormozgan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 791517919915519 Phone: +98 76 3334 7000 Mobile: +98 917 308 5779 Fax: Email: Pkamkar10@yahoo.com Web page address:
Sharing plan
yes
undecided
yesundecided
yes
no
yesno
yes
no
yesno
yes
no
yesno
yes
no
yesno
yes
no
yesno
yes
no
yesno
empty
There is no further information
There is no further information
empty
اطلاعات بیشتری وجود ندارد
اطلاعات بیشتری وجود ندارد
the data will be collected by the colleagues participating in the project
empty
the data will be collected by the colleagues participating in the project
داده ها توسط همکاران شرکت کننده در پروژه جمع آوری خواهد شد
empty
داده ها توسط همکاران شرکت کننده در پروژه جمع آوری خواهد شد
6 month
empty
6 month
6 ماه
empty
6 ماه
corresponding Author: Dr. Parvin Kamkar, Dr. Malihe Mohammad zade,
empty
corresponding Author: Dr. Parvin Kamkar, Dr. Malihe Mohammad zade,
نویسندگان مسئول: دکتر پروین کامکار، دکتر ملیحه محمدزاده،
empty
نویسندگان مسئول: دکتر پروین کامکار، دکتر ملیحه محمدزاده،
Only for data collection and analysis
empty
Only for data collection and analysis
صرفا جهت جمع آوری دیتا و آنالیز
empty
صرفا جهت جمع آوری دیتا و آنالیز
corresponding Author: Dr. Parvin Kamkar, Dr. Malihe Mohammad zade
empty
corresponding Author: Dr. Parvin Kamkar, Dr. Malihe Mohammad zade
نویسندگان مسئول: دکتر پروین کامکار، دکتر ملیحه محمدزاده
empty
نویسندگان مسئول: دکتر پروین کامکار، دکتر ملیحه محمدزاده
Written request and request of the project manager and main collaborators (Dr. Parvin Kamkar, Dr. Malihe Mohammad zade, Dr. Ebrahim Eftekhar, Narjes Seddighi)
empty
Written request and request of the project manager and main collaborators (Dr. Parvin Kamkar, Dr. Malihe Mohammad zade, Dr. Ebrahim Eftekhar, Narjes Seddighi)
درخواست و درخواست کتبی مدیر پروژه و همکاران اصلی (دکتر پروین کامکار، دکتر ملیحه محمد زاده، دکتر ابراهیم افتخار، نرجس صدیقی)
empty
درخواست و درخواست کتبی مدیر پروژه و همکاران اصلی (دکتر پروین کامکار، دکتر ملیحه محمد زاده، دکتر ابراهیم افتخار، نرجس صدیقی)
Protocol summary
Study aim
The aim of the present study is to investigate the effect of Q10 on laboratory findings in thalassemia patients treated with Iron chelators.
Design
This study is a double-blind parallel clinical trial with a 3-month intervention period, in which people are divided into two groups of 43 people randomly using Randomized Allocation Software.
Settings and conduct
This study will be conducted at Shahid Mohammadi Hospital and Aburihan Bandar Abbas Center affiliated with Hormozgan University of Medical Sciences. After explaining the study to the patient and obtaining informed consent, the patients are placed in one group and the treatment begins.
At the beginning and at the end of the study (3 months later), 10 cc of blood and urine tests were also performed to check the effectiveness of the treatment.
In this study, blinding will be done for participants, personnel, and researchers. In this way, drugs and placebo will be placed in the same packages by a person outside the study.
Participants/Inclusion and exclusion criteria
Patients with major and intermedia beta-thalassemia disease; patients who have had a history of taking Iron chelators regularly in the past three months, if they wish to cooperate (consent form will be completed by the parents of the patients for children under 18 years old and the patients themselves for patients over 18 years old).
Intervention groups
Group 1) 100 mg of ketones will be given daily for 3 months to thalassemia patients treated with Iron chelators.
Group 2) Placebo pill (100mg) which does not contain an interfering agent, was given daily for 3 months to thalassemia patients treated with Iron chelators will be given.
Main outcome variables
Determining the effectiveness of intervention after treatment using laboratory parameters (urea, creatinine, GFR, uric acid, pr/cr ratio) Using a biochemistry autoanalyzer device
General information
Reason for update
Due to the fact that most thalassemia patients take several drugs at the same time, we decided to investigate different drugs so that more people are included in the study and different patients are investigated.
Acronym
IRCT registration information
IRCT registration number:IRCT20221102056386N1
Registration date:2023-03-03, 1401/12/12
Registration timing:prospective
Last update:2023-07-19, 1402/04/28
Update count:2
Registration date
2023-03-03, 1401/12/12
Registrant information
Name
Narjes Seddighi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 917 185 1678
Email address
narjes.seddighi80@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-08, 1402/01/19
Expected recruitment end date
2024-03-09, 1402/12/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Q10 on laboratory findings in thalassemia patients treated with Iron chelators: a double-blind clinical trial
Public title
Investigating the effect of Q10 in thalassemia patients treated with Iron chelators
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with major and intermedia beta thalassemia disease
History of taking Iron chelators regularly in the last three months
Age between 2 and 65 years
Exclusion criteria:
Having an active infection
Existence of contraindications to the studied drugs
Age
From 2 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
Before starting the study, all participants will be explained that they will be divided into two intervention (A) and control (B) groups.
In this trial, we had two groups of 4 blocks (including 2 participants in drug group A and 2 participants in placebo group B). Production tools are also used from random sequence generation software (random allocation software) that this sequence generation software gives items that are able to generate a random sequences by block building method on simple structures.
Blocked randomization is for the purpose of making sure that precisely equal number of participants are included in the intervention and control group at consecutive but equal time intervals.
The randomization process is done by methodology consultant and the clinical researchers are not aware of the randomization method. Concealment Allocation refers to the method used to perform a random sequence on participants in the study, in such a way that the allocated group is not known before the allocation of the individual.
By using opaque and sealed envelopes with a random sequence (Sequentially numbered, seal, opaque envelopes), in this method, each of the random sequences created is recorded on a card, and the cards are placed inside the envelopes in order They are placed. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, blinding will be done for participants and researchers. In this way, the medicine and placebo will be placed in the same packages by a person outside the study, which will be labeled with A and B codes. The given codes will be provided to researchers after statistical analysis and when writing the article. To blind the participants and reduce their bias, it was explained to them only at the beginning of the study that they will receive one of two types of intervention and they will not be told the exact type of supplement.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hormozgan University of Medical Sciences
Street address
Imam Hossein Blvd., Hormozgan University of Medical Sciences Campus, Research and Technology Vice-Chancellor Building
City
Bandarabbas
Province
Hormozgan
Postal code
7919693116
Approval date
2022-12-18, 1401/09/27
Ethics committee reference number
IR.HUMS.REC.1401.309
Health conditions studied
1
Description of health condition studied
Thalassemia
ICD-10 code
D56
ICD-10 code description
Thalassemia
Primary outcomes
1
Description
Glomerular filtration rate
Timepoint
At the beginning and end of the third month of using Q10
Method of measurement
Autoanalyzer device
2
Description
Blood Urea Nitrogen
Timepoint
At the beginning and end of the third month of using Q10
Method of measurement
Autoanalyzer device
3
Description
Creatinine
Timepoint
At the beginning and end of the third month of using Q10
Method of measurement
Autoanalyzer device
4
Description
Uric acid
Timepoint
At the beginning and end of the third month of using Q10
Method of measurement
Autoanalyzer device
5
Description
Pr/Cr ratio
Timepoint
At the beginning and end of the third month of using Q10
Method of measurement
Autoanalyzer device
Secondary outcomes
1
Description
Side effects of the studied drugs, especially those such as hypersensitivity reactions, allergies, shock, anemia, hypotension, nausea and vomiting, diarrhea, gastrointestinal spasms, weakness and lethargy, headache, and rash.
Timepoint
Side effects are recorded daily in the studied groups.
Intervention group: Receiving 100 mg of Q10 tablets (Provided by Shari Pharmaceutical Company) daily for 3 months to thalassemia patients treated with Iron chelators
Category
Treatment - Drugs
2
Description
Control group: Includes patients who receive 100 mg of placebo daily, which does not contain any type of intervention agent, for three months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
The Great Prophet Research and Educational Complex Research Center
Full name of responsible person
Dr Parvin Kamkar
Street address
The Great Prophet Research and Educational Complex Research Center, Shahid Mohammadi Hospital, Jomhory Blvd, Old Airport, Bandar Abbas, Iran
City
Bandarabbas
Province
Hormozgan
Postal code
7919693116
Phone
+98 917 767 9591
Email
Pkamkar10@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
vali alipoor
Street address
Vice Chancellor Deputy of research and technology, Campus of University of Medical Sciences, Nabout Town, in front of Kargaran Sports Club, at the beginning of Imam Hossein Boulevard, Bandar Abbas, Iran
City
Bandarabbas
Province
Hormozgan
Postal code
79151
Phone
+98 76 3333 7192
Email
research@hums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr Malihe Mohamadzade
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Educational and Research Complex of the Great Prophet , Shahid Mohammadi Hospital, Jomhory Blvd, Old Airport, Bandar Abbas, Iran
City
Bandarabbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3371 0373
Email
mohammadzadeh_aa@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr Parvin Kamkar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Nephrology
Street address
Educational and Research Complex of the Great Prophet , Shahid Mohammadi Hospital, Jomhory Blvd, Old Airport, Bandar Abbas, Iran
City
BandarAbbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 7000
Email
Pkamkar10@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Narjes Seddighi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Laboratory Medicine
Street address
Student Research Committee,Faculty of Para-Medicine,Hormozgan University of Medical Sciences, Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7916839319
Phone
+98 76 3366 6367
Email
narjes.seddighi80@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available