Effects of Chinese medicine and Lactobacillus on persistent HPV infection
Effects of Estrogen-like Chinese Medicine and Vaginal Lactobacillus on HPV Clearance and Vaginal Microbiota Change in Women With Persistent HPV Infection
NA · Peking University People's Hospital · NCT06467942
This study is testing whether traditional Chinese medicine and Lactobacillus can help women with long-lasting high-risk HPV infections clear the virus and improve their vaginal health.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 25 Years and up |
| Sex | Female |
| Sponsor | Peking University People's Hospital (other) |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06467942 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of traditional Chinese medicine and Lactobacillus on women with persistent high-risk HPV infections lasting over one year. It involves a double-blind randomized trial where participants are divided into four groups: one receiving traditional Chinese medicine, another receiving Lactobacillus, a combination group, and a control group with no medication. The study aims to assess changes in vaginal microbiota, HPV load, and PAX1 methylation after treatment, with follow-up testing conducted at 6 and 12 months. The goal is to improve the vaginal microenvironment and potentially enhance HPV clearance.
Who should consider this trial
Good fit: Ideal candidates are women over 25 years old with persistent high-risk HPV infections for more than one year and no high-grade lesions.
Not a fit: Patients with high cytological risk or those diagnosed with high-grade lesions will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel treatment option for women with persistent HPV infections, potentially reducing the risk of cervical cancer.
How similar studies have performed: While the use of Lactobacillus in HPV treatment has shown promise in preliminary studies, the combination with traditional Chinese medicine is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women over 25 years of age with the same type of high-risk HPV infection lasting for more than 1 year, atypical squamous cell (ASCUS) or Low-grade squamous intraepithelial disease (LSIL) cytologically negative or undiagnosable, and pathological biopsy results negative or LSIL * Consent to use the device for contraception during the study period; * agree with medicine and follow-up management procedure. Exclusion Criteria: * High cytological risk, including atypical squamous cells (ASC-H),HSIL and atypical glandular cell (AGC), which could not rule out high-grade squamous intraepithelial lesions; * pathological biopsy for HSIL and above; * for any drug allergies; * pregnancy or lactation
Where this trial is running
Beijing, Beijing Municipality
- Peking University People's Hospital — Beijing, Beijing Municipality, China (RECRUITING)
Study contacts
- Principal investigator: Mingzhu Li — Peking University People's Hosptial
- Study coordinator: Mingzhu Li, doctor
- Email: mingzhu1815@163.com
- Phone: 86+15910691947
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.
Conditions: Human Papilloma Virus Infection