Ignite Creation Date:
2024-05-06 @ 3:27 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04633330
Status:
RECRUITING
Last Update Posted:
2024-01-05
First Post:
2020-10-26
Brief Title:
Evaluation of AHCC for the Clearance of High Risk-HPV Infections in Chinese Female
Sponsor:
Shandong University
Organization:
Shandong University
Study Overview
Official Title:
Evaluation of Efficacy of AHCCfor the Clearance of High Risk-HPV Infections in Chinese Female A Multi-centre Randomised Double Blind and Placebo-controlled Study
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multi-centre randomised double blind placebo-controlled study on female participants with diagnosis of high-risk human papillomavirus HR-HPV infection to evaluate the clearance capacity of AHCC
Detailed Description:
Worldwide cervical cancer is the fourth most common malignancy in women and a major cause of morbidity and mortality It accounts for nearly 10 of all cancers The etiology of cervical cancer has been identified and confirmed associated with high risk-human papillomavirus HR-HPV When HR-HPV infections persist overtime patients have an increased risk of developing cervical cancer The proprietary a standardized extract of cultured Lentinula edodes mycelia ECLM AHCC was developed in Japan in 1992 Several studies have reported a variety of therapeutic effects including antioxidant and anticancer activity and improvement of immune response
As recently reported study on AHCC pre-clinical in vitro and in vivo evidence demonstrated its durable clearance of HR-HPV infections The preliminary data from the two pilot studies suggested that AHCC supplementation supports the host immune system for successful clearance of HR-HPV infections A confirmatory phase II randomized double-blinded placebo-controlled study is about completion The preliminary results of this phase II study confirmed data observed in pilot studies that AHCC supplementation for at least 6 months is associated with a 60 successful elimination of HPV infections and confirmed IFN-β correlates with clearance of persistent HPV infections The optimal duration of AHCC supplementation required after the first negative result still needs more evaluation in future clinical studies
Nevertheless all above mentioned studies have included western participants solely The aim of this study is to evaluate the clearance capacity of AHCC on Chinese female participants with diagnosis of HR-HPV infection
As recently reported study on AHCC pre-clinical in vitro and in vivo evidence demonstrated its durable clearance of HR-HPV infections The preliminary data from the two pilot studies suggested that AHCC supplementation supports the host immune system for successful clearance of HR-HPV infections A confirmatory phase II randomized double-blinded placebo-controlled study is about completion The preliminary results of this phase II study confirmed data observed in pilot studies that AHCC supplementation for at least 6 months is associated with a 60 successful elimination of HPV infections and confirmed IFN-β correlates with clearance of persistent HPV infections The optimal duration of AHCC supplementation required after the first negative result still needs more evaluation in future clinical studies
Nevertheless all above mentioned studies have included western participants solely The aim of this study is to evaluate the clearance capacity of AHCC on Chinese female participants with diagnosis of HR-HPV infection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None