Protocol summary
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Study aim
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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
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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;
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Intervention groups
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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.
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Main outcome variables
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White Blood Cell, َAcute Neutrophil Count, Acute lymphocyte Count
General information
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Reason for update
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Determining the real sample size that performed and modifying the work method
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Acronym
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IRCT registration information
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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
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Registration date
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2020-05-26, 1399/03/06
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-02-20, 1398/12/01
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Expected recruitment end date
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2020-05-19, 1399/02/30
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Actual recruitment start date
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2020-02-20, 1398/12/01
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Actual recruitment end date
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2020-06-21, 1399/04/01
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Trial completion date
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2020-06-21, 1399/04/01
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Scientific title
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Evaluation of the effectiveness and safety of Royal Jelly on the number of white blood cells in patients with acute lymphoblastic leukemia
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Public title
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Royal Jelly in acute leukemia
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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To 18 years old
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Gender
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Both
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Phase
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1-2
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Groups that have been masked
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No information
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Sample size
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Target sample size:
20
Actual sample size reached:
26
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Single
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Other design features
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The study is before and after type
Ethics committees
1
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Ethics committee
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Approval date
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2019-08-18, 1398/05/27
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Ethics committee reference number
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IR.IUMS.FMD.REC.1398.173
Health conditions studied
1
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Description of health condition studied
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Acute lymphoblastic lymphoma ( ALL )
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ICD-10 code
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C91.0
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ICD-10 code description
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Acute lymphoblastic leukemia [ALL]
Primary outcomes
1
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Description
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total ٌWhite blood cell count
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Timepoint
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from beginning ( before using a Jelly ), then every two week until 6 weeks
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Method of measurement
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Complete blood count (CBC)
2
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Description
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acute lymphocyte count
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Timepoint
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from beginning ( before using a Jelly ), then every two week until 6 weeks
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Method of measurement
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Complete blood count (CBC) /Differential Cell Exam
3
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Description
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acute Neutrophil count
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Timepoint
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from beginning ( before using a Jelly ), then every two week until 6 weeks
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Method of measurement
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Complete blood count (CBC) /differential cell exam
Intervention groups
1
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Description
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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.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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This study is a before-after phase 1 clinical trial, It will also be done as a Pilot, and the results can be shared.
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When the data will become available and for how long
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After publishing the article
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To whom data/document is available
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Researchers, doctors
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Under which criteria data/document could be used
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This study is a small-scale, pilot study, and is expected to be investigated with a bigger sample size after termination.
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From where data/document is obtainable
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Rozhin pahlevani's Email Addresses:
Pahlevan.r@iums.ac.ir
Rozhin.pahlevan@gmail.com
Rozhin_p92Yahoo.com
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What processes are involved for a request to access data/document
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Once the article is published, applicants can receive information about the data through the email addresses provided.
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Comments
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