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利用者名:
UMIN ID:

試験進捗状況 主たる結果の公表済み/Main results already published
UMIN試験ID UMIN000020859
受付番号 R000024073
科学的試験名
一般公開日(本登録希望日) 2016/02/05
最終更新日 2017/02/16

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title
Effects of Royal Jelly Supplementation on Regulatory T Cells and Lymphocytes Apoptosis in Children with Systemic Lupus Erythematosus
一般向け試験名略称/Acronym
Royal Jelly Supplementation in SLE
科学的試験名/Scientific Title
Effects of Royal Jelly Supplementation on Regulatory T Cells and Lymphocytes Apoptosis in Children with Systemic Lupus Erythematosus
科学的試験名略称/Scientific Title:Acronym
Royal Jelly Supplementation in SLE
試験実施地域/Region
アフリカ/Africa

対象疾患/Condition
対象疾患名/Condition
Systemic Lupus Erythematosus.
疾患区分1/Classification by specialty
膠原病・アレルギー内科学/Clinical immunology
疾患区分2/Classification by malignancy 悪性腫瘍以外/Others
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/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.
目的2/Basic objectives2 有効性/Efficacy
目的2 -その他詳細/Basic objectives -Others

試験の性質1/Trial characteristics_1
試験の性質2/Trial characteristics_2
試験のフェーズ/Developmental phase

評価/Assessment
主要アウトカム評価項目/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.
副次アウトカム評価項目/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.

基本事項/Base
試験の種類/Study type 介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design 単群/Single arm
ランダム化/Randomization 非ランダム化/Non-randomized
ランダム化の単位/Randomization unit
ブラインド化/Blinding オープン/Open -no one is blinded
コントロール/Control 無対照/Uncontrolled
層別化/Stratification
動的割付/Dynamic allocation
試験実施施設の考慮/Institution consideration
ブロック化/Blocking
割付コードを知る方法/Concealment

介入/Intervention
群数/No. of arms 1
介入の目的/Purpose of intervention 治療・ケア/Treatment
介入の種類/Type of intervention
食品/Food
介入1/Interventions/Control_1
two-month Royal Jelly (2 gm) treatment
介入2/Interventions/Control_2

介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit
8 歳/years-old 以上/<=
年齢(上限)/Age-upper limit
17 歳/years-old 以下/>=
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria
children with SLE
除外基準/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.
目標参加者数/Target sample size 30

責任研究者/Research contact person
責任研究者/Name of lead principal investigator

ミドルネーム


ミドルネーム
Khaled Saad
所属組織/Organization
Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
所属部署/Division name
pediatrics
郵便番号/Zip code
住所/Address
Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
電話/TEL +20882413683
Email/Email med@aun.edu.eg

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person

ミドルネーム


ミドルネーム
Khaled Saad
組織名/Organization
Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
部署名/Division name
pediatrics
郵便番号/Zip code
住所/Address
Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
電話/TEL +20882368373
試験のホームページURL/Homepage URL
Email/Email med@aun.edu.eg

実施責任組織/Sponsor
機関名/Institute その他 Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
機関名/Institute
(機関選択不可の場合)

部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
機関名/Organization
(機関選択不可の場合)

組織名/Division
組織の区分/Category of Funding Organization 海外/Outside Japan
研究費拠出国/Nationality of Funding Organization


その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization

住所/Address

電話/Tel
Email/Email

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2016 02 05

関連情報/Related information
プロトコル掲載URL/URL releasing protocol
試験結果の公開状況/Publication of results 最終結果が公表されている/Published

結果/Result
結果掲載URL/URL related to results and publications
組み入れ参加者数/Number of participants that the trial has enrolled
主な結果/Results

主な結果入力日/Results date posted
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
参加者背景/Baseline Characteristics

参加者の流れ/Participant flow

有害事象/Adverse events

評価項目/Outcome measures

個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 主たる結果の公表済み/Main results already published
プロトコル確定日/Date of protocol fixation
2015 08 01
倫理委員会による承認日/Date of IRB
登録・組入れ開始(予定)日/Anticipated trial start date
2015 09 01
フォロー終了(予定)日/Last follow-up date
2016 01 15
入力終了(予定)日/Date of closure to data entry
2016 01 21
データ固定(予定)日/Date trial data considered complete
2016 01 31
解析終了(予定)日/Date analysis concluded
2016 02 01

その他/Other
その他関連情報/Other related information


管理情報/Management information
登録日時/Registered date
2016 02 03
最終更新日/Last modified on
2017 02 16


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000024073
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024073

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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