Cervical high-risk HPV persistent infection with cervical lesions
Conditions
Interventions
Treatment group:Topical use of freeze-dried powder containing Nr-CWS
Placebo group:Topical placebo
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
Female
Age
21 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in this trial and sign an informed consent; 2. Women aged 21 to 65 years old who have sex; 3. Patients diagnosed with high-risk cervical HPV persistent infection for 12 months or more, or CIN I with high-risk HPV The infection lasts for 12 months or more, or the positive subtype after CIN?/CIN? treatment is the same as before the operation, and the non-CIN2+ confirmed by colposcopy and cervical biopsy; 4. Consent to participate in the trial period to use effective contraception, and during the treatment period Those who are prohibited from having sex; 5. Those who are willing and promise to cooperate in accordance with the requirements of the plan; Note: HPVDNA testing, cytology and cervical biopsy reports are subject to within 3 months before enrollment.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women, female subjects who have not taken effective contraceptive measures or planned to give birth within one year; 2. Diagnosed as CIN II/CIN III by colposcopy and cervical tissue biopsy, or cervical cancer and cervical cancer after surgery, Or recurrence after CIN II/CIN III; 3. Patients with severe heart, lung, liver and kidney diseases; 4. AIDS, lupus erythematosus, selective IgA deficiency, chronic lymphocytic leukemia, multiple myeloma, lymph Patients with immune system diseases such as tumors or malignant tumors; 5. Those who have used corticosteroids, immunosuppressants, immunomodulators or other drugs that act on the immune system; 6. Within past 12 weeks received systemic or local antiviral treatment; 7. Within past 2 weeks received vaginal drug treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HPV DNA typing test;HPV negative conversion; | — |
Countries
China
Contacts
Public ContactLang Jinghe
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed