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Protocol summary
This study will be performed in Ali Asghar Pediatric Hospital, Initially, patients with ALL will undergo a complete blood cell ( CBC ) test and will receive 2 g of royal jelly in oral form, daily for a period of 12 weeks and will be given a CBC test each week.
Every two weeks, if needed, depending on the response of the WBC to treatment, the amount of royal jelly will be increased (up to 3 times a day: 6 g) and after 12 weeks the WBC changes, the ANC as well as the ALC in these patients will be compared to their baseline. WBC-enhancing drugs such as granulocyte colony-stimulating factor, will not be used.
This study will be performed in Ali Asghar Pediatric Hospital, Initially, patients with ALL will undergo a complete blood cell ( CBC ) test and will receive 2 g of royal jelly in oral form, daily for a period of 6 weeks and will be given a CBC test every 2 weeks.
Every two weeks, if needed, depending on the response of the WBC to treatment, the amount of royal jelly will be increased (up to 3 times a day: 6 g) and after 6weeks the WBC changes, the ANC as well as the ALC in these patients will be compared to their baseline. WBC-enhancing drugs such as granulocyte colony-stimulating factor, will not be used.
This study will be performed in Ali Asghar Pediatric Hospital, Initially, patients with ALL will undergo a complete blood cell ( CBC ) test and will receive 2 g of royal jelly in oral form, daily for a period of 126 weeks and will be given a CBC test each weekevery 2 weeks. Every two weeks, if needed, depending on the response of the WBC to treatment, the amount of royal jelly will be increased (up to 3 times a day: 6 g) and after 12 weeks6weeks the WBC changes, the ANC as well as the ALC in these patients will be compared to their baseline. WBC-enhancing drugs such as granulocyte colony-stimulating factor, will not be used.
این مطالعه در بیمارستان کودکان حضرت علی اصغر ، انجام خواهد شد .
در ابتدا از بیماران مبتلا به لوکمی لنفوبلاستیک حاد آزمایش کامل سلولهای خونی انجام میگردد و طی مدت 12 هفته روزانه 2 گرم ژل رویال به صورت خوراکی دریافت خواهند کرد و هر هفته آزمایش کامل سلولهای خونی انجام خواهند شد.
هر دو هفته در صورت نیاز و بر حسب پاسخ شمارش گلبولهای سفید به درمان ، میزان ژل رویال بالا برده خواهد شد ( تا حداکثر 3 بار در روز:6 گرم) و پس از 12 هفته میزان تغییر شمارش کلی گلبولهای سفید خون ، شمارش مطلق نوتروفیلها و همچنین شمارش مطلق لنفوسیتها در این بیماران با میزان پایه ی خودشان مقایسه خواهد شد. از داروهای افزایش دهنده گلبولهای سفید همچون فاکتور محرک کُلونی گرانولوسیت استفاده نخواهد شد.
این مطالعه در بیمارستان کودکان حضرت علی اصغر ، انجام خواهد شد .
در ابتدا از بیماران مبتلا به لوکمی لنفوبلاستیک حاد آزمایش کامل سلولهای خونی انجام میگردد و طی مدت 6 هفته روزانه 2 گرم ژل رویال به صورت خوراکی دریافت خواهند کرد و هر 2هفته آزمایش کامل سلولهای خونی انجام خواهند شد.
هر دو هفته در صورت نیاز و بر حسب پاسخ شمارش گلبولهای سفید به درمان ، میزان ژل رویال بالا برده خواهد شد ( تا حداکثر 3 بار در روز:6 گرم) و پس از 6 هفته میزان تغییر شمارش کلی گلبولهای سفید خون ، شمارش مطلق نوتروفیلها و همچنین شمارش مطلق لنفوسیتها در این بیماران با میزان پایه ی خودشان مقایسه خواهد شد. از داروهای افزایش دهنده گلبولهای سفید همچون فاکتور محرک کُلونی گرانولوسیت استفاده نخواهد شد.
این مطالعه در بیمارستان کودکان حضرت علی اصغر ، انجام خواهد شد . در ابتدا از بیماران مبتلا به لوکمی لنفوبلاستیک حاد آزمایش کامل سلولهای خونی انجام میگردد و طی مدت 126 هفته روزانه 2 گرم ژل رویال به صورت خوراکی دریافت خواهند کرد و هر هفته2هفته آزمایش کامل سلولهای خونی انجام خواهند شد. هر دو هفته در صورت نیاز و بر حسب پاسخ شمارش گلبولهای سفید به درمان ، میزان ژل رویال بالا برده خواهد شد ( تا حداکثر 3 بار در روز:6 گرم) و پس از 126 هفته میزان تغییر شمارش کلی گلبولهای سفید خون ، شمارش مطلق نوتروفیلها و همچنین شمارش مطلق لنفوسیتها در این بیماران با میزان پایه ی خودشان مقایسه خواهد شد. از داروهای افزایش دهنده گلبولهای سفید همچون فاکتور محرک کُلونی گرانولوسیت استفاده نخواهد شد.
General information
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2020-02-20, 1398/12/01
2020-02-20 00:00:00
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2020-06-21, 1399/04/01
2020-06-21 00:00:00
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2020-06-21, 1399/04/01
2020-06-21 00:00:00
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Determining the real sample size that performed and modifying the work method
Determining the real sample size that performed and modifying the work method
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تعیین حجم نمونه واقعی انجام شده و اصلاح روش انجام کار
تعیین حجم نمونه واقعی انجام شده و اصلاح روش انجام کار
Primary outcomes
#1
from beginning ( before using a Jelly ), then every two week until 12 weeks
from beginning ( before using a Jelly ), then every two week until 6 weeks
from beginning ( before using a Jelly ), then every two week until 126 weeks
در ابتدای ورود افراد ( قبل از مصرف ژل) و سپس هر دو هفته تا 12 هفته
در ابتدای ورود افراد ( قبل از مصرف ژل) و سپس هر دو هفته تا 6 هفته
در ابتدای ورود افراد ( قبل از مصرف ژل) و سپس هر دو هفته تا 126 هفته
#2
from beginning ( before using a Jelly ), then every two week until 12 weeks
from beginning ( before using a Jelly ), then every two week until 6 weeks
from beginning ( before using a Jelly ), then every two week until 126 weeks
در ابتدای ورود افراد ( قبل از مصرف ژل) و سپس هردو هفته تا 12 هفته
در ابتدای ورود افراد ( قبل از مصرف ژل) و سپس هردو هفته تا 6 هفته
در ابتدای ورود افراد ( قبل از مصرف ژل) و سپس هردو هفته تا 126 هفته
#3
from beginning ( before using a Jelly ), then every two week until 12 weeks
from beginning ( before using a Jelly ), then every two week until 6 weeks
from beginning ( before using a Jelly ), then every two week until 126 weeks
در ابتدای ورود افراد ( قبل از مصرف ژل) و سپس هر دو هفته تا 12 هفته
در ابتدای ورود افراد ( قبل از مصرف ژل) و سپس هر دو هفته تا 6 هفته
در ابتدای ورود افراد ( قبل از مصرف ژل) و سپس هر دو هفته تا 126 هفته
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: معاون تحقیقات و فناوری
Full name of responsible person - Persian: Vice President of Research and Technology
Street address - English: No. 4, Elahie 19, Elahie complex, End of koohsar Blvd., Shahran
Street address - Persian: شهران، انتهای بلوار کوهسار، شهرک الهیه، الهیه 19، واحد 4
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1488874645
Phone: +98 21 4431 9829
Fax:
Email: Pahlevan.r@iums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr Seyyed Abbas Motevalian
Full name of responsible person - Persian: دکتر سید عباس متولیان
Street address - English: Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
Street address - Persian: تهران، بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1449614535
Phone: +98 21 8670 2503
Fax:
Email: motevalian.a@iums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: معاون تحقیقات و فناوریDr Seyyed Abbas Motevalian Full name of responsible person - Persian: Vice President of Research and Technologyدکتر سید عباس متولیان Street address - English: No. 4, Elahie 19, Elahie complex, EndIran University of koohsar Blvd.Medical Sciences, ShahranShahid Hemmat Highway, Tehran Street address - Persian: شهرانتهران، انتهای بلوار کوهساربزرگراه همت جنب برج میلاد، شهرک الهیه، الهیه 19، واحد 4دانشگاه علوم پزشکی ایران City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 14888746451449614535 Phone: +98 21 4431 98298670 2503 Fax: Email: Pahlevan.rmotevalian.a@iums.ac.ir Web page address:
Protocol summary
Study aim
Determination of the effect of royal jelly on total white blood cells ( WBC) in children with acute lymphoblastic leukemia ( ALL ) treated in Ali Asghar Pediatric Hospital
Design
A semi-experimental study of pre- and post-treatment clinical trials (phase 1), with 20 samples used as a pilot study.
The sampling method will be in the available form.
Settings and conduct
This study will be performed in Ali Asghar Pediatric Hospital, Initially, patients with ALL will undergo a complete blood cell ( CBC ) test and will receive 2 g of royal jelly in oral form, daily for a period of 6 weeks and will be given a CBC test every 2 weeks.
Every two weeks, if needed, depending on the response of the WBC to treatment, the amount of royal jelly will be increased (up to 3 times a day: 6 g) and after 6weeks the WBC changes, the ANC as well as the ALC in these patients will be compared to their baseline. WBC-enhancing drugs such as granulocyte colony-stimulating factor, will not be used.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Patients with (ALL); undergoing complete maintenance and remission;
Having a normal heart echo;
No history of asthma;
No history of allergy to honey and its products.
Exclusion Criteria:
underlying heart and pulmonary problem;
A history of allergies to honey and its products;
Intervention groups
Children with ALL who are in maintenance or complete remission.
The study will be performed on individuals before and after consuming royal jelly. Royal Jelly is a natural honey product that starts with a daily dose of 2 grams up to a maximum of three times a day. Patients are tested every two weeks and the dose is increased as needed.
The control group is the same patients before the royal jelly was used, which is measured on the basis of experiments upon arrival.
Main outcome variables
White Blood Cell, َAcute Neutrophil Count, Acute lymphocyte Count
General information
Reason for update
Determining the real sample size that performed and modifying the work method
Acronym
IRCT registration information
IRCT registration number:IRCT20190106042260N1
Registration date:2020-05-26, 1399/03/06
Registration timing:registered_while_recruiting
Last update:2020-06-29, 1399/04/09
Update count:1
Registration date
2020-05-26, 1399/03/06
Registrant information
Name
Rozhin Pahlevani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4431 9829
Email address
pahlevan.r@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-05-19, 1399/02/30
Actual recruitment start date
2020-02-20, 1398/12/01
Actual recruitment end date
2020-06-21, 1399/04/01
Trial completion date
2020-06-21, 1399/04/01
Scientific title
Evaluation of the effectiveness and safety of Royal Jelly on the number of white blood cells in patients with acute lymphoblastic leukemia
Public title
Royal Jelly in acute leukemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with acute lymphoblastic leukemia who are in the complete maintenance and remission phase.
Having a normal heart echo
No history of asthma
No history of allergy to honey and its products
Exclusion criteria:
history of allergy to honey and its products
history of asthma
Cardiomyopathy and underlying heart problem
Age
To 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
20
Actual sample size reached:
26
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
The study is before and after type
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
No4, Elahieh 19, Elahieh Complex, end of Kuhsar Blvd, shahran, tehran,Iran
City
Tehran
Province
Tehran
Postal code
14888774645
Approval date
2019-08-18, 1398/05/27
Ethics committee reference number
IR.IUMS.FMD.REC.1398.173
Health conditions studied
1
Description of health condition studied
Acute lymphoblastic lymphoma ( ALL )
ICD-10 code
C91.0
ICD-10 code description
Acute lymphoblastic leukemia [ALL]
Primary outcomes
1
Description
total ٌWhite blood cell count
Timepoint
from beginning ( before using a Jelly ), then every two week until 6 weeks
Method of measurement
Complete blood count (CBC)
2
Description
acute lymphocyte count
Timepoint
from beginning ( before using a Jelly ), then every two week until 6 weeks
Intervention group: Children with acute lymphoblastic lymphoma ( before entering the study and using a jelly)، The gel used is Royal Jelly, which is a honey product that is completely natural and has an official license. Royal Jelly belongs to Khansar Company and the health monitoring ID is 10/15551. Dosage starts at two grams per day orally and is up to 12 grams three times a day. The patient is tested every two weeks and the dose is increased accordingly. Children with acute lymphoblastic leukemia will be screened before and after using royal jelly.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali asghar children`s hospital
Full name of responsible person
Rozhin Pahlevani
Street address
No.4, Elahieh 19, Elahieh complex, End of koohsar Blvd., Shahran
City
Tehran
Province
Tehran
Postal code
1488874645
Phone
+98 21 4431 9829
Email
Pahlevan.r@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Seyyed Abbas Motevalian
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
motevalian.a@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Rozhin Pahlevani
Position
Pediatric resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No. 4, Elahie 19, Elahie complex, End of koohsar Blvd., Shahran
City
Tehran
Province
Tehran
Postal code
1488874645
Phone
+98 21 4431 9829
Email
Pahlevan.r@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Rozhin Pahlevani
Position
Pediatric resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No19, Elahieh complex, End of koohsar BLV.,Shahran,Tehran
City
Tehran
Province
Tehran
Postal code
1488874645
Phone
+98 21 4431 9829
Fax
Email
rozhin.pahlevan@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Rozhin Pahlevani
Position
Pediatric resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No. 4, Elahie 19, Elahie complex, End of koohsar Blvd., Shahran
City
Tehran
Province
Tehran
Postal code
1488874645
Phone
+98 21 4431 9829
Email
Pahlevan.r@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
This study is a before-after phase 1 clinical trial, It will also be done as a Pilot, and the results can be shared.
When the data will become available and for how long
After publishing the article
To whom data/document is available
Researchers, doctors
Under which criteria data/document could be used
This study is a small-scale, pilot study, and is expected to be investigated with a bigger sample size after termination.