Actively Recruiting

Phase Not Applicable
Age: 25Years +
FEMALE
NCT06467942

Effects of Chinese Medicine and Lactobacillus in Persistent HPV Infection

Led by Peking University People's Hospital · Updated on 2024-06-21

240

Participants Needed

1

Research Sites

95 weeks

Total Duration

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AI-Summary

What this Trial Is About

High risk human papillomavirus (hr-HPV) persistent infection is a high risk factor for cervical cancer. 85% to 90% of hr-HPV infections have the ability to clear on their own, while 10% to 15% of HPV persists further will lead to the development of high-grade intraepithelial lesions (HSIL) and even to invasive cervical cancer. Long-term follow-up results for persistent hr-HPV infection showed that cervical HSIL mostly occurred after 5-7 years of persistent hr-HPV infection, among which the risk of HPV16 and 18 was the highest, followed by HPV31 and 33. The role of the vaginal microbiome (CVM) in persistent hr-HPV infection has been increasingly valued, and women with persistent HPV infection that progresses to HSIL have a more unstable vaginal microenvironment. The previous study found that Lactobacillus vaginalis may contribute to HPV clearance by improving the vaginal microenvironment. In addition, previous studies have found that estrogen-like Chinese medicine could increase glycogen, improve mucosal estrogen levels, increase lactobacillus content, and promote HPV clearance. It is a challenge to make clinical management on when and how to intervene among hr-HPV persistent infection but whose pathology does not suggest HSIL. This study intends to analyze the correlation between the duration of HPV infection and the current vaginal microbiome, HPV load and PAX1 methylation in people with persistent HPV infection at different ages, and observe the changes of the above indicators after the administration of drugs to improve the vaginal microenvironment, which is helpful for preventing HPV persistent infection and developing into true precancerous lesions. It has the clinical and practical value of "preparing for a rainy day".

CONDITIONS

Official Title

Effects of Chinese Medicine and Lactobacillus in Persistent HPV Infection

Who Can Participate

Age: 25Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 lesion (LSIL) cytology negative or undiagnosable
  • Pathological biopsy results negative or LSIL
  • Consent to use contraception during the study period
  • Agree to use medicine and follow-up procedures
Not Eligible

You will not qualify if you...

  • High cytological risk including atypical squamous cells (ASC-H), HSIL, and atypical glandular cell (AGC) where high-grade lesions cannot be ruled out
  • Pathological biopsy showing HSIL or higher
  • Allergy to any study medications
  • Pregnancy or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Peking University People's Hospital

Beijing, Beijing Municipality, China, 100044

Actively Recruiting

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Research Team

M

Mingzhu Li, doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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Effects of Chinese Medicine and Lactobacillus in Persistent HPV Infection | DecenTrialz