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

Phase 2

Not yet recruiting

• Conditions: Human Papillomavirus (HPV) Infection; Cervical Cancer
• Interventions: Drug: Cnidium Monnieri Detoxification Formula

• Registration Number: NCT06705322
• Lead Sponsor: Fudan University

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.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-23
• Study First Submitted QC: 2024-11-23
• Last Update Submitted: 2024-11-23
• Study First Posted: 2024-11-26
• Last Update Posted: 2024-11-26
• Study Start: 2024-12-01
• Primary Completion: 2027-03-27
• Study Completion: 2027-03-27

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 79

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (Cnidium Monnieri Detoxification Formula)	Cnidium Monnieri Detoxification Formula	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.

Primary Outcome Measures

Name	Time	Method
Baseline HPV clearance at 6 months after treatment	6 months	HPV clearance rate at 6 months after treatment

Secondary Outcome Measures

Name	Time	Method
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