A study for evaluation of AHCC(R) on eradication of Human papillomavirus

JRCT ID: jRCTs011180021

Registered date:19/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Positive cytodiagnosis, positive for high-risk HPV
• Date of first enrollment: 17/01/2019
• Target sample size: 180
• Study type: Interventional
• Intervention(s): Oral intake of AHCC(R)

Outcome(s)

• Primary Outcome: Persistent infection of high-risk type HPV
• Secondary Outcome: Subjective symptom evaluation

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 54age old
• Gender: Female

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Watari Hidemichi
• Source(s) of Monetary Support: Amino Up Co., Ltd.
• Secondary ID(s): UMIN000036062