Persistent high-risk HPV infection in the cervix
Conditions
Interventions
Experimental Group:Cedrela latex gel
Parallel control group:Control drug
Sponsors
Fudan University Affiliated Obstetrics and Gynecology Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Individuals with high-risk HPV positive infection in the cervix for 6 months or more; 2. Cervical histopathological results showing chronic cervicitis or CIN1; 3. Syndrome of damp-Heat and blood stasis obstrution in leucorrhea(according to TCM pattern differentiation); 4. Age between 18-50 years (inclusive), with a history of sexual activity, and premenopausal women; 5. Regular menstrual cycle, with a cycle length of =21 days and =35 days, and menstrual duration of =3 days and =7 days; 6. Participants agree to use condoms for contraception during the entire duration of sexual activity during the trial period; 7. Voluntarily participate in the trial study and have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Abnormal development of the reproductive system or previous total hysterectomy; 2. History of malignant tumors of the reproductive system (e.g., cervical cancer, endometrial cancer, vaginal cancer, vulvar cancer, etc.); 3. TCT results showing HSIL or invasive cancer; cervical histopathology results showing CIN2 or CIN3 and above; 4. Cervical canal curettage (ECC) performed, with histopathology results showing LSIL or above; 5. Acute genital infections requiring treatment; 6. Severe primary diseases of the cardiovascular, cerebrovascular, hepatic, renal, or hematopoietic systems; or known severe immunodeficiency; or mental disorders; 7. Within 3 months prior to the trial, physical therapy (e.g., cryotherapy, etc.) or surgical treatment (e.g., cold knife conization, LEEP, etc.) has been used or deemed necessary by the investigator for CIN; 8. Use of immunomodulatory agents or drugs targeting HPV (e.g., interferon, imiquimod, etc.) within 1 month prior to enrollment; 9. Pregnancy, lactation, within 3 months postpartum, or positive pregnancy test prior to administration; 10. Allergy to the drugs used in this study; 11. History of severe drug abuse or alcoholism, or inability to abstain from excessive alcohol consumption, smoking, or drug abuse during the trial; 12. Concurrent vaginal or vulvar intraepithelial lesions within the past 3 months; 13. Participation in other clinical trials within the past 3 months; 14. As judged by the investigator, unsuitable for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| High-Risk HPV Genotype Clearance Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction Rate of High-Risk HPV Subtype Positivity;Cervical histopathology reversion rate;Efficacy of Traditional Chinese Medicine (TCM) Syndromes and Changes in Scoring; | — |
Countries
China
Contacts
Public ContactSui Long
Fudan University Affiliated Obstetrics and Gynecology Hospital
Outcome results
None listed