A Multicenter, Randomized, Double-blind, Dose-parallel, Placebo-controlled Phase III 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
- 3 期
- 状态
- 招募中
- 入组人数
- 414
- 试验地点
- 1
- 主要终点
- Pain disappearance rate after 12 weeks of treatment
研究概览
简要总结
The objective of this phase III trial 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 III 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, 414 subjects were enrolled and randomized to either "Jincaopian Tablets" group, or the "placebo" group in a 2:1 ratio. The treatment period is 12 weeks and the follow-up period is 4 weeks.
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 50 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 50 (including 18 and 50) 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 6 months after the trial;
- •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;
- •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;
- •Liver function: ALT or AST>1.5 times the upper limit of normal value；Renal function：Scr>1.0 times the upper limit of normal value;
- •Serum CA125 and erythrocyte sedimentation > 1.1 times the upper limit of normal value.
- •Combined with serious cardiovascular, cerebrovascular, hematopoietic system and other serious diseases;
- •Have an allergic history to the experimental drug;
- •Have a long history of alcoholism or drug abuse;
- •Intellectual disabilities or mental disorders;
- •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 group
Patients receive Jincaopian Tablets 0.6g/day for 12 weeks.
干预措施: Jincaopian Tablets (Drug)
Placebo group
Patients receive a placebo 0.6g/day for 12 weeks.
干预措施: Placebo (Other)
结局指标
主要结局
Pain disappearance rate after 12 weeks of treatment
时间窗: 12 Weeks
The pain disappearance referred to the Visual Analogue Scale (VAS) score becoming 0-1 points, and was no longer greater than or equal to 2 points at any subsequent evaluation. The pain disappearance rate was defined as the proportion of patients who achieved a pain disappearance after treatment.
次要结局
- The area under the VAS score-time curve(12 Weeks)
- Pain disappearance rate after 4 and 8 weeks of treatment(8 Weeks)
- Change of weekly average Visual Analogue Scale (VAS) score from baseline after 12 weeks of treatment(12 Weeks)
- McCormick Scale(12 Weeks)
- General quality of life (Short Form-12) scale(12 Weeks)
- Disease efficacy evaluation(12 Weeks)
- Adverse events (AEs)(12 Weeks)