Clinical trial NCT06705322: Cnidium Monnieri Detoxification Formula for Persistent High-risk Human Papillomavirus Infection of Cervix.
Official title: A Phase II, Multicenter Study on the Clinical Effectiveness of Cnidium Monnieri Detoxification Formula for Persistent High-risk Human Papillomavirus Infection of Cervix.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Human Papillomavirus (HPV) Infection
Cervical Cancer
Keywords: Human papillomavirus infection
Cervical cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 79
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Baseline HPV clearance at 6 months after treatment
timeFrame: 6 months
Secondary outcomes:
measure: Baseline HPV clearance at 12 months after treatment
timeFrame: 12 months
measure: Safety
timeFrame: 6 months
Other outcomes:
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