ITMCTR2100004529尚未招募2 期
Efficacy and safety of Baofukang suppository in the treatment of cervical high-risk human papillomavirus 16/18 (HR-HPV16/18) infection combined with high-grade squamous intraepithelial lesions (P16 positive CIN II): a randomized, double-blind, placebo-controlled, multicenter phase II clinical trial
Beijing Tsinghua Changgeng Hospital0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 50（—）
- 性别
- Female
入选标准
- •(1) HPV16 or HPV18 were positive by cobas4800 HPV test;
- •(2) The results of colposcopy were satisfactory, and the histopathology was CINII (P16 positive);
- •(3) The menstrual cycle is regular, menstrual cycle >= 25 days and <= 40 days, menstrual cycle >= 3 days and <= 7 days;
- •(4) Age 18-50 years old (including the cut-off value), sexual life history, postmenopausal women;
- •(5) During the trial and within 6 months after the end of the trial, there was no pregnancy plan. At the same time, they voluntarily complied with the requirement that only condoms (without sex hormones) should be used for contraception;
- •(6) Voluntary participation in the study, and has signed the informed consent.
排除标准
- •(1) Abnormal development of reproductive system (such as imperforate hymen, vaginal atresia, etc.), or previous total cervical resection;
- •(2) Those who have received HPV vaccination in the past;
- •(3) Vaginal wall or fornix with vaginal intraepithelial neoplasia (VaIN);
- •(4) Patients with previous malignant tumors of reproductive system (such as cervical cancer or endometrial cancer, vaginal cancer, vulvar cancer, etc.);
- •(5) The results of cervical histopathology were CINI,CINII (P16 negative) or CIN III or above;
- •(6) Patients with severe upper and lower genital tract infection, or cervical gonococcal, mycoplasma or chlamydia infection;
- •(7) The patients who were not satisfied with colposcopy and needed ECC;
- •(8) They are complicated with serious primary diseases such as heart, brain, liver, kidney and hematopoietic system (such as malignant tumor), or known severe low immune function (such as AIDS, systemic lupus erythematosus and other serious diseases of immune system, malignant tumor after radiotherapy and chemotherapy, organ transplantation, etc.), or mental disease, or liver and kidney function damage (alt, AST >= upper limit of normal value x 1.5 times), The creatinine was higher than the upper limit of normal value;
- •(9) Within 3 months before participating in the trial, those who had used physical therapy (such as cryotherapy, laser ablation, electrocautery and condensation) or surgical treatment (such as cold knife conization, LEEP, laser conization) for cervical HR-HPV combined with cervical intraepithelial lesions (CIN) or who were judged by researchers to need physical therapy (such as cryotherapy, laser ablation, electrocautery and condensation, etc.) or surgical treatment (such as cold knife conization, LEEP, laser conization, etc.);
- •(10) Within 4 weeks before participating in the trial, they had used drugs (including traditional Chinese medicine, chemical drugs, biological products, etc.) or mechanical and Xiaozi products for the treatment of cervical HR-HPV with CIN;
- •(11) Those who used oral contraceptives, glucocorticoids or immunosuppressants within 3 months before the use of test drugs;
- •(12) In pregnancy, lactation;
- •(13) Allergic to Baofukang suppository;
- •(14) Those with a history of alcohol abuse, long-term smoking or drug abuse, or unable to stop drinking, smoking or drug abuse during the trial period;
- •(15) Those who have participated in other clinical trials in recent 3 months;
- •(16) According to the judgment of the researcher, it is not suitable to participate in the trial.
研究者
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