Cervical Cancer, Human Papillomavirus (HPV) Infection
Conditions
Keywords
Human papillomavirus infection, Cervical cancer
Brief summary
The purpose of this study is to evaluate the clinical efficacy and safety of Cnidium Monnieri Detoxification Formula in clearing HPV infection, improving clinical symptoms and quality of life in female patients with persistent cervical high-risk HPV infection.
Detailed description
Persistent infection with high-risk HPV is a major cause of cervical cancer and has negative psychosocial effects on women's health-related quality of life (QOL). This prospective, single-arm, multicenter study is to evaluate the clinical efficacy and safety of Cnidium Monnieri Detoxification Formula in clearing HPV infection, improving clinical symptoms and quality of life in female patients with persistent cervical high-risk HPV infection.
Interventions
DRUGCnidium Monnieri Detoxification Formula
Drug composition of Cnidium Monnieri Detoxification Formula: snake seed 9g, Tuckaia 30g, Matrine 9g, snake berry 30g, white Ying 30g. Based on the Cnidium Monnieri Detoxification Formula, the other symptoms were treated with syndrome differentiation and flavor. The traditional Chinese medicine decoction is provided by the Pharmacy of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine, with 1 dose per day, decocted into 300ml by a medicine decocter, packed in 2 vacuum bags, taken orally after meals, twice a day, one bag each time. Do not stop taking decoction during menstruation. 1 month is a course of treatment, at least 3 courses of treatment, no more than 6 courses of treatment. Baseline HPV clearance, improvement in clinical symptoms and quality of life, and drug safety were assessed at 3 months, 6 months, and 12 months after initiation of treatment.
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 25 years to ≤ 75 years，with sexual life history * Meet the diagnostic criteria for high-risk human papillomavirus (HR-HPV) persistent infection * After surgery or physical therapy for high-grade squamous intraepithelial lesions (HSIL) of the cervix or high-grade squamous intraepithelial lesions (VaINIII) of the vagina, or radical surgery for cervical/vaginal cancer or radical chemoradiotherapy, the examination remained positive for HR-HPV ≥6 months after the end of treatment, with the same type or multiple types as before treatment, and no progression or recurrence of the disease. * No local or systemic therapy has been administered to patients in the last 3 months * Patients were informed of the study protocol, agreed to cooperate with the treatment, and signed informed consent.
Exclusion criteria
* Only low-risk HPV infection * Colposcopy for high-grade intraepithelial lesions or cancer of the cervix, vagina, vulva, who have not received or are receiving treatment * Immunocompromised or immunosuppressant * Pregnant and lactating women * Patients with other malignant tumors not controlled, serious heart, lung, liver, renal insufficiency and coagulation dysfunction * People with communication or cognitive impairment * Patients have contraindications to oral administration of traditional Chinese medicine preparations * In the same period, other anti-HPV measures were used to treat, which affected the efficacy judgment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline HPV clearance at 6 months after treatment | 6 months | HPV clearance rate at 6 months after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baseline HPV clearance at 12 months after treatment | 12 months | HPV clearance rate at 12 months after treatment |
| Safety | 6 months | Proportion of adverse events within 6 months of treatment |
Contacts
Primary ContactTingyan Shi
Outcome results
None listed