UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036062 |
|---|---|
| Receipt number | R000041073 |
| Scientific Title | Controlled study for evaluation of the effect of AHCC(R) intake on eradication of high-risk type Human papillomavirus infection |
| Date of disclosure of the study information | 2019/03/01 |
| Last modified on | 2022/08/01 05:07:25 |
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Basic information
Public title
Controlled study for evaluation of the effect of AHCC(R) intake on eradication of high-risk type Human papillomavirus infection
Acronym
A study for evaluation of AHCC(R) on eradication of Human papillomavirus
Scientific Title
Controlled study for evaluation of the effect of AHCC(R) intake on eradication of high-risk type Human papillomavirus infection
Scientific Title:Acronym
A study for evaluation of AHCC(R) on eradication of Human papillomavirus
Region
| Japan |
Condition
Condition
High-risk type Human papillomavirus (HPV) infection
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the functional food, AHCC(R) on eradication of high-risk HPV infection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Persistent high-risk HPV infection
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Consumption of the functional food, AHCC(R) (3 g/day) for 4, 8 or 12 months. HPV testing will be conducted every 4 months, and intervention will cease upon confirmation of HPV negative result.
Interventions/Control_2
Consumption of the placebo (3 g/day) for 4, 8 or 12 months. HPV testing will be conducted every 4 months, and intervention will cease upon confirmation of HPV negative result.
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
| 25 | years-old | <= |
Age-upper limit
| 44 | years-old | >= |
Gender
Female
Key inclusion criteria
(a) Women with a cytology positive, high risk (hr) HPV positive result. (hrHPV includes type 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68)
(b) Women aged 25-44 yrs (at registration)
(c) Women who have provided informed written consent.
Key exclusion criteria
(a) Women diagnosed as having a histological diagnosis of Cervical Intraepithelial Neoplasia (CIN) grade 3 or worse, or who are in need of medical treatment
(b) Women taking immuno suppressors such as steroids or biologics such as TNF-alpha
(c) Women regularly taking immunostimulating supplements
(d) Women with an uncontrolled progressive malignancy
(e) Women suffering from any mental illness or mental symptoms which would make it difficult for them to participate in the study
(f) Women who are unable to return for follow-up appointments.
(g) Women who are or may be pregnant
(h) Women who, for any other reason, are considered not suitable for participation by the investigators
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidemichi Watari |
Organization
Hokkaido University Hospital
Division name
Gynecology
Zip code
Address
Kita14, Nishi5, Kita-Ku, Sapporo Hokkaido 060-8648, Japan
TEL
011-716-1161
watarih@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sharon Hanley |
Organization
Hokkaido University Hospital
Division name
Gynecology
Zip code
Address
Kita14, Nishi5, Kita-Ku, Sapporo Hokkaido 060-8648, Japan
TEL
011-716-1161
Homepage URL
sjbh1810@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Amino Up Co., Ltd.
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
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
| 2019 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 09 | Month | 04 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 01 | Day |
Last modified on
| 2022 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041073
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
