Evaluation of AHCC® for the Clearance of High Risk-HPV Infections in Chinese Female

Launched by SHANDONG UNIVERSITY · Nov 11, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a supplement called AHCC® on women with high-risk human papillomavirus (HR-HPV) infections. Researchers want to see if AHCC® can help clear these infections, which can sometimes lead to health issues like cervical cancer. The trial is looking for women who are not menopausal and have been diagnosed with HR-HPV and low-grade squamous intraepithelial lesions (LSIL). To be eligible, participants must have had at least one positive HR-HPV test in the past year, be willing to use effective birth control during the study, and have normal blood and organ function.

Women who join the trial can expect to receive either the AHCC® supplement or a placebo (a non-active pill) without knowing which one they are getting, as the study is designed to be double-blind. This means neither the participants nor the researchers will know who is receiving the actual treatment to ensure fair results. The trial is currently recruiting participants, and it aims to provide valuable insights into the potential benefits of AHCC® for managing HR-HPV infections.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Sign the informed consent form
• • Not menopausal
• * Met persistent HR-HPV infection criteria:
• • At least one HR-HPV positive test over 12 months prior to screening
• • HR-HPV positive diagnosis by Cobas assay within 3 months prior to screening
• • Low grade squamous intraepithelial lesion (LSIL) diagnosis by cytology within 6 months prior to screening
• • Willing to take effective contraception method during study period.
• • Negative urine pregnancy test within 7 days prior to screening
• • Normal haematology, kidney and liver functions: ANC≥1,500 cells/mm3, platelets 100,000≥cells/mm3, creatinine clearance ≥60mL/min (estimated using Cockcroft Gault equation), total bilirubin, serum alanine aminotransferase (SGPT), serum aspartate aminotransferase (SGOT), and alkaline phosphatase ≤ normal value 1.5 Times.
• Exclusion Criteria:
• • With following medical history within 6 months prior to screening: myocardial infarction, unstable angina, heart failure, or un-controlled hypertension (\>140/90 mmHg)
• • Systemic treatment for HR-HPV infection has been performed within three months before screening
• • Acute genital tract infection
• • Previously or currently diagnosed as malignant tumour
• • The cytological diagnosis is: ASC-H, AGC tends to become tumorous and other high-risk lesions
• • The histological diagnosis is High grade squamous intraepithelial lesion (HSIL)
• • Pregnant or breastfeeding
• • A history of hepatitis (autoimmune, A, B, or C) or positive antigen
• • There is a clear history of mental confusion (schizophrenia, two-way affection, psychosis) or uncontrolled epilepsy
• • The main gynaecologist believes that there are significant medical complications, including immunosuppressive conditions (such as HIV, Rheumatoid arthritis, etc.) or are taking immunomodulators (such as immunosuppressive agents)
• • Participants with autoimmune diseases
• • Taking AHCC® capsules before screening
• • Taking other immune-modulating nutritional supplements
• • Planned hysterectomy (excluding subtotal hysterectomy)
• • Considered by investigators as unsuitable participant of this study