Single-arm, Prospective Study of the Efficacy and Safety of Paiteling®Antibacterial Liquid in the Treatment of Persistent Cervical HR-HPV Infection

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age26-65
SponsorThe First Hospital of Jilin University

About this trial

The effectiveness of Patellin ® antibacterial solution in treating persistent cervical HR-HPV infection

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1 、 Age 25 to 65 years (inclusive), persistent cervical HR-HPV infection (HR-HPV persistent infection refers to infection with the same high-risk HPV subtypes for ≥2 years (this can be from different testing companies; for multiple infections, only one subtyping of HPV persistence is required)); if the cervical biopsy shows chronic cervicitis or low-grade cervical intraepithelial neoplasia; 2. Sexual history; 3. No relevant anti-HPV virus treatment (vaginal or systemic) in the 3 months prior to visit; 4. No pregnancy plan within 6 months of visit 5、 Voluntary signing of informed consent.

Disqualifiers

1、 Cervical biopsy results of TCT or HSIL; 2 、 Cervical HR-HPV infection subtypes changed or reversed to negative; 3. Pregnant or lactating women; 4. Acute inflammation of the genital tract; 5Recent immunodeficiency (chemoradiotherapy, AIDS, SLE); 6. Patients with severe diseases such as diabetes, cardiovascular disease, brain, liver, kidney and hematopoietic system, and mental illness; 7. Those with a history of drug allergy and allergic constitution; 8 Patients who have participated in other clinical trials in the last three months; 9. Suspected or confirmed history of alcohol or drug abuse, or other lesions or conditions that reduce the possibility of enrollment or complicate enrollment, such as frequent changes in work environment and unstable living environment that are likely to cause loss of follow-up, according to the investigator's judgment.

Trial design

Design model

Single group

Treatments tested in this trial

  • Patling ® Antibacterial Liquid

    Drug

    Apply Patling ® antibacterial solution locally to the cervix

Treatment groups

115 Participants
are divided into 1 treatment group
Group A: Single-arm, prospective study of the efficacy and safety of Paiteling®Antibacterial Liquid in the trExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The effectiveness of Patellin ® antibacterial solution in treating persistent cervical HR-HPV infection

Cervical HR-HPV persistent infection HR-HPV seroconversion rate: 5 The rate of turning negative: refers to the reexamination of patients' HR-HPV at a specified time after the end of treatment. Turning negative is defined as the reversal of HR-HPV from persistently positive at enrollment to negative, including all HR-HPV being negative and the reversal of persistently positive HR-HPV to negative while other subtypes are positive. The HR-HPV of the subjects was reviewed 12 months after treatment, and the seroconversion rate of the subtypes of HR-HPV infection that persisted at the time of enrollment was observed and recorded, defined as the seroconversion at that time point.

Time frame
24 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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