UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036062
Receipt No. 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 2019/03/01

* 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 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
Obsterics 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
Email 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
Email sjbh1810@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

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
Email

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
Anticipated trial start date
2018 Year 10 Month 23 Day
Last follow-up date
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
2019 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041073

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.