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.
Investigators
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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