Cnidium Monnieri Detoxification Formula for Persistent High-risk Human Papillomavirus Infection of Cervix.

Fudan University

Status and phase: Not yet enrolling; Phase 2

Conditions: Cervical Cancer; Human Papillomavirus (HPV) Infection

Treatments: Drug: Cnidium Monnieri Detoxification Formula

Study type: Interventional

Funder types: Other

Identifiers

NCT06705322

zsfud-HPV-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 79 estimated patients

Sex: Female

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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79 participants in 1 patient group

Treatment (Cnidium Monnieri Detoxification Formula)

Experimental group

Description:

Take Cnidium Monnieri Detoxification Formula orally for at least 3 months. 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.

Treatment:

Drug: Cnidium Monnieri Detoxification Formula