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Clinical Trials/JPRN-jRCTs011180021
JPRN-jRCTs011180021
Recruiting
Phase 3

Controlled study for evaluation of the effect of AHCC(R) intake on eradication of high-risk type Human papillomavirus infection - HPV-AHCC Study

Watari Hidemichi0 sites180 target enrollmentMarch 19, 2019

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Positive cytodiagnosis, positive for high-risk HPV
Sponsor
Watari Hidemichi
Enrollment
180
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 19, 2019
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
Watari Hidemichi

Eligibility Criteria

Inclusion Criteria

  • 1\. Patients that have tested positive for high\-risk HPV through cytologic screening and HPV testing. (For the purposes of this study, high\-risk HPV is judged as types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68\.)
  • 2\. Patients that are between the ages of 20 and 54 upon date of registration for the study
  • 3\. Patients that, upon receiving a full explanation regarding study participation, fully understand what participation entails and have provided their informed consent in writing.

Exclusion Criteria

  • 1\. Patients that grade higher than CIN3 through tissue screening, or for whom treatment has been judged necessary.
  • 2\. Patients currently taking immunosuppressant medication such as steroids, or medication which suppresses TNF\-alpha production.
  • 3\. Patients who are regularly taking supplements which may influence immune function.
  • 4\. Patients with uncontrolled, progressive malignant tumors.
  • 5\. Patients with mental illness, or symptoms of mental illness, for whom study participation has been judged to be difficult.
  • 6\. Patients who are unable to return to the institution for follow\-up testing.
  • 7\. Patients who are pregnant, or who may possibly become pregnant.
  • 8\. Patients who are menopause.
  • 9\. Patients who, for reasons other than those stated above, have been deemed as incompatible with the study by the physician\-in\-charge.

Outcomes

Primary Outcomes

Not specified

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