A Multicenter, Randomized, Double-blind, Dose-parallel, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of Jincaopian Tablets in Subjects With Chronic Pelvic Pain After Pelvic Inflammatory Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Modified McCormick Scale
研究概览
简要总结
This phase II trial attempts to evaluate the efficacy and safety of Jincaopian Tablets in the treatment of subjects with chronic pelvic pain after pelvic inflammatory disease.
详细描述
Chronic pelvic pain is the major sequela of pelvic inflammatory disease and it's a common, burdensome, and costly condition that disproportionately affects women. This multicenter, randomized, double-blind, dose-parallel, placebo-controlled phase II clinical trial is designed to evaluate the efficacy and safety of Jincaopian Tablets in the treatment of subjects with chronic pelvic pain after pelvic inflammatory disease. In this trial, 180 subjects were enrolled and randomized to either "high-dose Jincaopian Tablets" group, "low-dose Jincaopian Tablets " group, or the "placebo" group in a 1:1:1 ratio. The treatment period is 12 weeks and the follow-up period is 4 weeks. The outcome measures of chronic pelvic pain relief in this trial are pain visual analog scale (VAS), modified McCormick scale and SF-12 Score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria for chronic pelvic pain sequelae of pelvic inflammatory disease;
- •The average VAS score of pain in the week before enrollment is ≥4;
- •The McCormack scale of physical signs at the time of enrollment is 4 to 12 points (including 4 points and 12 points);
- •Women aged 18 to 55 (including 18 and 55) with a history of sexual life;
- •Voluntarily participate in this clinical trial, give informed consent and sign the informed consent form.
排除标准
- •Pelvic inflammatory disease (acute attack);
- •Pregnant or lactating women, women of childbearing age who are unwilling to take effective measures to prevent pregnancy during the trial and within 3 months after the trial;
- •Critically ill or with surgical indications;
- •Previously diagnosed with cervical intraepithelial neoplasia, primary/secondary dysmenorrhea, pelvic stasis syndrome and chronic pelvic pain caused by other non-pelvic inflammatory diseases;
- •Complicated with specific vaginitis such as vulvovaginal candidiasis, trichomonas vaginitis, bacterial vaginosis, etc.;
- •Gynecological tumors (maximum diameter of uterine fibroids greater than 3cm and submucosal fibroids), endometriosis, adenomyosis, acute cervicitis, tuberculous pelvic inflammatory disease, interstitial cystitis and other diseases related symptoms;
- •Placement of intrauterine device in the past 3 months; absence of uterus and bilateral appendages;
- •Received related treatment or took drugs with similar functions and indications within 14 days before the introduction;
- •Have a history of allergy to the components of the test drug;
- •Participated in other clinical trials within the past 3 months;
- •The investigator believes that it is not suitable to participate in this clinical trial.
研究组 & 干预措施
Jincaopian Tablets high-dose group
Patients receive high dose Jincaopian Tablets 0.6g/day for 12 weeks.
干预措施: Jincaopian Tablets high dose (Drug)
Jincaopian Tablets low-dose group
Patients receive low dose Jincaopian Tablets 0.3g/day for 12 weeks.
干预措施: Jincaopian Tablets low dose (Drug)
Placebo group
Patients receive a matching placebo for 12 weeks.
干预措施: Placebo (Other)
结局指标
主要结局
Modified McCormick Scale
时间窗: Baseline and at Weeks 4, 8, 12, 16
To evaluate the total score of the physical sign scale and the scores of each part including abdominal tenderness, rebound tenderness, and gynecological examination compared with the baseline in each group at weeks 4, 8, 12, 16.
SF-12 Score
时间窗: Baseline and at Weeks 12
To evaluate the health status of the patients compared with the baseline in each group at weeks 12.
Pain Visual Analog Scale (VAS)
时间窗: Baseline to 16 weeks
To measure patient's pain intensity (most commonly) along a 100 mm horizontal line daily.
次要结局
未报告次要终点