A Phase II, Multicenter Study on the Clinical Effectiveness of Cnidium Monnieri Detoxification Formula for Persistent High-risk Human Papillomavirus Infection of Cervix.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 79
- 主要终点
- Baseline HPV clearance at 6 months after treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Treatment (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.
干预措施: Cnidium Monnieri Detoxification Formula (Drug)
结局指标
主要结局
Baseline HPV clearance at 6 months after treatment
时间窗: 6 months
HPV clearance rate at 6 months after treatment
次要结局
- Baseline HPV clearance at 12 months after treatment(12 months)
- Safety(6 months)