NCT06705322

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

A Phase II, Multicenter Study on the Clinical Effectiveness of Cnidium Monnieri Detoxification Formula for Persistent High-risk Human Papillomavirus Infection of Cervix.

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 79 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 25 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Human Papillomavirus (HPV) Infection
• Cervical Cancer

Interventions

Type	Name	Description
DRUG	Cnidium 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.

Timeline

• Start date: 2024-12-01
• Primary completion: 2027-03-27
• Completion: 2027-03-27
• First posted: 2024-11-26
• Last updated: 2024-11-26