UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020859 |
|---|---|
| Receipt number | R000024073 |
| Scientific Title | Effects of Royal Jelly Supplementation on Regulatory T Cells and Lymphocytes Apoptosis in Children with Systemic Lupus Erythematosus |
| Date of disclosure of the study information | 2016/02/05 |
| Last modified on | 2017/02/16 14:45:51 |
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Basic information
Public title
Effects of Royal Jelly Supplementation on Regulatory T Cells and Lymphocytes Apoptosis in Children with Systemic Lupus Erythematosus
Acronym
Royal Jelly Supplementation in SLE
Scientific Title
Effects of Royal Jelly Supplementation on Regulatory T Cells and Lymphocytes Apoptosis in Children with Systemic Lupus Erythematosus
Scientific Title:Acronym
Royal Jelly Supplementation in SLE
Region
| Africa |
Condition
Condition
Systemic Lupus Erythematosus.
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To the best of our knowledge, no previous studies on the immunomodulatory effect of royal jelly administration on SLE patients in humans.
Our aim was to study the effect of royal jelly administration on the disease course of pediatric SLE with some immunological markers (the CD4 Tregs and CD8 Tregs) and lymphocytes apoptosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In the current study, we found that the children with SLE (in both before and after treatment groups) had significantly lower levels of CD4 Treg and Foxp3 expression in CD4+CD25+High versus normal control group. Also, the levels of CD4 and Foxp3 expression were negatively correlated with disease activity as detected by SLEDAI index.
Key secondary outcomes
After RJ treatment, we found a significant increase in CD4 Treg and in the expression of Foxp3 in CD4+CD25+High versus baseline values. In parallel to this significant laboratory value, we found a significant improvement in the disease activity as detected by SLEDAI index after 2 months of RJ treatment which was correlated with the significant changes in CD4 Treg and Foxp3 expression. CD4 T lymphocytes count was increased after RJ treatment versus baseline value. Also the CD4/CD8 ratio is showing significant improvement after RJ treatment in SLE group.
As regards to the effect of RJ treatment on lymphocytes apoptosis in our study, we found that the apoptotic CD4 T lymphocytes showed significant reduction to about its quarter of the baseline values before treatment to a values about normal as normal control group. Again in correlation with the previous CD8 T lymphocytes count, the changes in apoptotic CD8 T lymphocytes were not significant between any of the 3 groups.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
two-month Royal Jelly (2 gm) treatment
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 8 | years-old | <= |
Age-upper limit
| 17 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
children with SLE
Key exclusion criteria
Patients and controls with known diabetes, subjects who had received a 'recent' vaccination, were excluded from the study. Any patient had recent infection or received any immunosuppressive medications e.g. steroids, etc. during one month prior to enrollment were also excluded.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Khaled Saad |
Organization
Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
Division name
pediatrics
Zip code
Address
Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
TEL
+20882413683
med@aun.edu.eg
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Khaled Saad |
Organization
Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
Division name
pediatrics
Zip code
Address
Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
TEL
+20882368373
Homepage URL
med@aun.edu.eg
Sponsor or person
Institute
Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
Institute
Department
Personal name
Funding Source
Organization
Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 01 | Month | 15 | Day |
Date of closure to data entry
| 2016 | Year | 01 | Month | 21 | Day |
Date trial data considered complete
| 2016 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 03 | Day |
Last modified on
| 2017 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024073
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