UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042794 |
|---|---|
| Receipt number | R000048849 |
| 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 |
| Date of disclosure of the study information | 2020/12/19 |
| Last modified on | 2020/12/19 12:13:11 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of regular papaya consumption in glaucoma patients
Acronym
POAG
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
Scientific Title:Acronym
IOP,RNFL,ONH,TAC,POAG
Region
| Asia(except Japan) |
Condition
Condition
RANDOMISED CONTROLLED TRIAL
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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.
Basic objectives2
Others
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.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate the effect of papaya intake on intraocular pressure (IOP) in primary open angle glaucoma (POAG) patients.
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.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
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
Interventions/Control_2
control arm will consume their current diet and continue their current antiglaucoma medication
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
| 40 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
confirmed case of POAG, age between 40 and 70 years, good compliance with pressure lowering agents, and an achieved target IOP
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
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | chan |
| Middle name | Hui |
| Last name | tze |
Organization
Universiti Sains Malaysia
Division name
Ophthalmology and Visual Sciences
Zip code
16150
Address
Jabatan Oftalmologi , Hospital USM, Jalan Raja Perempuan Zainab 2 , kubang kerian
TEL
0060125678788
chanhuitze@gmail.com
Public contact
Name of contact person
| 1st name | chan |
| Middle name | hui |
| Last name | tze |
Organization
Universiti Sains Malaysia
Division name
Ophthalmology and Visual Sciences
Zip code
16150
Address
Jabatan Oftalmologi , Hospital USM, Jalan Raja Perempuan Zainab 2 , kubang kerian
TEL
0060125678788
Homepage URL
chanhuttze@gmail.com
Sponsor or person
Institute
Universiti Sains Malaysia
Institute
Department
Personal name
Funding Source
Organization
Universiti Sains Malaysia
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Universiti Sains Malaysia
Address
Jabatan Oftalmologi , Hospital USM, Jalan Raja Perempuan Zainab 2 , kubang kerian,16150, Kelantan,Malaysia
Tel
0060125678788
chanhuitze@gmail.com
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
| 2020 | Year | 12 | Month | 19 | Day |
Related information
URL releasing protocol
not applicable
Publication of results
Unpublished
Result
URL related to results and publications
not applicable
Number of participants that the trial has enrolled
40
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.
Results date posted
| 2020 | Year | 12 | Month | 19 | Day |
Results Delayed
Results Delay Reason
not appplicable
Date of the first journal publication of results
Baseline Characteristics
A randomized single-blinded controlled trial involving 40 patients with POAG
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.
Adverse events
none
Outcome measures
Effect of papaya intake on IOP, RNFL,ONH and serum TAC in POAG at baseline,1st,2nd and 3rd month
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 06 | Month | 15 | Day |
Date analysis concluded
| 2020 | Year | 01 | Month | 13 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 19 | Day |
Last modified on
| 2020 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048849
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
