Evaluating AHCC® for clearing high-risk HPV infections in women
Evaluation of Efficacy of AHCC®for the Clearance of High Risk-HPV Infections in Chinese Female: A Multi-centre, Randomised, Double Blind and Placebo-controlled Study
This study is testing if a supplement called AHCC® can help women with high-risk HPV infections clear the virus and improve their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 30 Years to 50 Years |
| Sex | Female |
| Sponsor | Shandong University Academic / other |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT04633330 on ClinicalTrials.gov |
What this trial studies
This multi-centre, randomized, double-blind, placebo-controlled study aims to assess the effectiveness of AHCC®, a standardized extract from Lentinula edodes mycelia, in clearing high-risk human papillomavirus (HR-HPV) infections in female participants. The study focuses on women diagnosed with persistent HR-HPV infections and low-grade squamous intraepithelial lesions (LSIL). Participants will receive either AHCC® capsules or a placebo for a specified duration, with the primary outcome being the clearance of HR-HPV infections. The study builds on preliminary data suggesting that AHCC® may enhance immune response and support the elimination of HPV infections.
Who should consider this trial
Good fit: Ideal candidates for this study are premenopausal women with a documented history of persistent HR-HPV infections and low-grade squamous intraepithelial lesions.
Not a fit: Patients with a recent history of serious cardiovascular conditions or those who are menopausal may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic option for women with persistent HR-HPV infections, potentially reducing the risk of cervical cancer.
How similar studies have performed: Preliminary studies on AHCC® have shown promising results in clearing HR-HPV infections, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Jinan, Shandong
- Qilu Hospital of Shandong University — Jinan, Shandong, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.