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利用者名:
UMIN ID:

試験進捗状況 試験終了/Completed
UMIN試験ID UMIN000042794
受付番号 R000048849
科学的試験名
一般公開日(本登録希望日) 2020/12/19
最終更新日 2020/12/19

※ 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
Effect of regular papaya consumption in glaucoma patients
一般向け試験名略称/Acronym
POAG
科学的試験名/Scientific Title
Effect of papaya intake on intraocular pressure, retinal nerve fiber layer thickness, optic nerve head parameters and serum total antioxidant capacity in primary open angle glaucoma patients
科学的試験名略称/Scientific Title:Acronym
IOP,RNFL,ONH,TAC,POAG
試験実施地域/Region
アジア(日本以外)/Asia(except Japan)

対象疾患/Condition
対象疾患名/Condition
RANDOMISED CONTROLLED TRIAL
疾患区分1/Classification by specialty
眼科学/Ophthalmology
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 evaluate the effect of papaya intake on intraocular pressure (IOP), retinal nerve fibre layer thickness (RNFL), optic nerve head (ONH) parameters and serum total antioxidant capacity (TAC) in primary open angle glaucoma (POAG) patients.
目的2/Basic objectives2 その他/Others
目的2 -その他詳細/Basic objectives -Others
To compare the IOP measurement, RNFL thickness, ONH parameters, and serum TAC at baseline, first, second and third month between POAG patients taking papaya and not taking papaya.
試験の性質1/Trial characteristics_1 探索的/Exploratory
試験の性質2/Trial characteristics_2 その他/Others
試験のフェーズ/Developmental phase 該当せず/Not applicable

評価/Assessment
主要アウトカム評価項目/Primary outcomes
To evaluate the effect of papaya intake on intraocular pressure (IOP) in primary open angle glaucoma (POAG) patients.
副次アウトカム評価項目/Key secondary outcomes
To compare the IOP measurement, RNFL thickness, ONH parameters, and serum TAC at baseline, first, second and third month between POAG patients taking papaya and not taking papaya.

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 並行群間比較/Parallel
ランダム化/Randomization ランダム化/Randomized
ランダム化の単位/Randomization unit 個別/Individual
ブラインド化/Blinding 介入実施者・測定者がブランド化されている単盲検/Single blind -investigator(s) and assessor(s) are blinded
コントロール/Control 実薬・標準治療対照/Active
層別化/Stratification いいえ/NO
動的割付/Dynamic allocation いいえ/NO
試験実施施設の考慮/Institution consideration 施設を考慮していない/Institution is not considered as adjustment factor.
ブロック化/Blocking いいえ/NO
割付コードを知る方法/Concealment 封筒法/Numbered container method

介入/Intervention
群数/No. of arms 2
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
intervention arm will consume 1 serving (about 250g) of fresh papaya fruits 3 times a week for 3 months duration on top of their current diet
Their current antiglaucoma medication are continued
介入2/Interventions/Control_2
control arm will consume their current diet and continue their current antiglaucoma medication
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
40 歳/years-old 以上/<=
年齢(上限)/Age-upper limit
70 歳/years-old 以下/>=
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria
confirmed case of POAG, age between 40 and 70 years, good compliance with pressure lowering agents, and an achieved target IOP
除外基準/Key exclusion criteria
(i) active smokers, (ii) irritable bowel disease, (iii) poorly controlled diabetes mellitus with HbA1c of >9.0%, (iv) a history of previous intraocular surgery within the past 6 months, other than uncomplicated cataract treatment (trabeculectomy or glaucoma drainage device implantation), and (v) media opacities that affected the reliability of optical coherence tomography (OCT) measurements (vi) allergic to papain (vii) history of taking antioxidant supplements 3 months prior to recruitment
目標参加者数/Target sample size 40

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

ミドルネーム

chan
ミドルネーム Hui
tze
所属組織/Organization
Universiti Sains Malaysia
所属部署/Division name
Ophthalmology and Visual Sciences
郵便番号/Zip code 16150
住所/Address
Jabatan Oftalmologi , Hospital USM, Jalan Raja Perempuan Zainab 2 , kubang kerian
電話/TEL 0060125678788
Email/Email chanhuitze@gmail.com

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

chan
ミドルネーム hui
tze
組織名/Organization
Universiti Sains Malaysia
部署名/Division name
Ophthalmology and Visual Sciences
郵便番号/Zip code 16150
住所/Address
Jabatan Oftalmologi , Hospital USM, Jalan Raja Perempuan Zainab 2 , kubang kerian
電話/TEL 0060125678788
試験のホームページURL/Homepage URL
Email/Email chanhuttze@gmail.com

実施責任組織/Sponsor
機関名/Institute その他 Universiti Sains Malaysia
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 Universiti Sains Malaysia
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 営利企業/Profit organization
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
Universiti Sains Malaysia
住所/Address
Jabatan Oftalmologi , Hospital USM, Jalan Raja Perempuan Zainab 2 , kubang kerian,16150, Kelantan,Malaysia
電話/Tel 0060125678788
Email/Email chanhuitze@gmail.com

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
2020 12 19

関連情報/Related information
プロトコル掲載URL/URL releasing protocol not applicable
試験結果の公開状況/Publication of results 未公表/Unpublished

結果/Result
結果掲載URL/URL related to results and publications not applicable
組み入れ参加者数/Number of participants that the trial has enrolled 40
主な結果/Results
There were significant intraocular pressure reduction and RNFL thickness increment after 3 months of regular papaya consumption. However no association seen with ONH and serum TAC parameters.
主な結果入力日/Results date posted
2020 12 19
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason
not appplicable
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
A randomized single-blinded controlled trial involving 40 patients with POAG
参加者の流れ/Participant flow
A randomized single-blinded controlled trial involving 40 patients with POAG was conducted between February 2018 and October 2019. The patients were divided into two groups (n=20): Group A consumed a single serving of papaya (~250 gm) three times a week for 3 months; Group B consumed a normal diet. Each group recorded daily dietary intakes, and the assigned treatment was continued throughout the study. IOP, RNFL, ONH parameters and serum TAC were recorded at baseline and then monthly for three months by a single blinded operator. Data were analyzed by repetitive-measure analysis of variance.
有害事象/Adverse events
none
評価項目/Outcome measures
Effect of papaya intake on IOP, RNFL,ONH and serum TAC in POAG at baseline,1st,2nd and 3rd month
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 試験終了/Completed
プロトコル確定日/Date of protocol fixation
2017 12 12
倫理委員会による承認日/Date of IRB
2018 02 15
登録・組入れ開始(予定)日/Anticipated trial start date
2018 03 11
フォロー終了(予定)日/Last follow-up date
2019 03 14
入力終了(予定)日/Date of closure to data entry
データ固定(予定)日/Date trial data considered complete
2019 06 15
解析終了(予定)日/Date analysis concluded
2020 01 13

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
2020 12 19
最終更新日/Last modified on
2020 12 19


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=R000048849
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048849

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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