A Randomized, Double-blind, Placebo-controlled Post-marketing Study to Assess the Treatment Effect of Sanjie Analgesic Capsule in Treating Endometriosis - Associated Pain
试验速览
- 阶段
- 4 期
- 入组人数
- 400
- 试验地点
- 14
- 主要终点
- dysmenorrhea
研究概览
简要总结
It is a multi-center, double -blind, placebo -controlled, randomized post-marketing study in Chinese subjects with endometriosis-associated pain to assess treatment effect and safety in the subjects treated with Sanjie Analgesic Capsule versus subjects treated with placebo.
详细描述
Sanjie Analgesic Capsule is a Chinese Traditional Patent Medicine. It is a botanical extract from the raw materials of the Resina Draconis , Panax Notoginseng, fritillary bulb and coix seed, which are derived from a classic prescription of traditional Chinese medicine.
Sanjie Analgesic Capsule was approved by CFDA in 2004, produced by means of modern technology by Jiangsu Kanion Pharmaceutical Co., Ltd. The study is a multi-center, double -blind, placebo-controlled, randomized in Chinese subjects with endometriosis-associated pain to assess treatment effect and safety in the subjects treated with Sanjie Analgesic Capsule versus subjects treated with placebo.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects have a diagnosis of endometriosis by laparoscopy within 5 years prior to signing ICF, main complain of dysmenorrhea (or menstrual pain or painful periods) and with VAS score of 4 or above; Endometriosis combined with uterine adenomyosis is included.
- •Female between the ages of 18 and 45 years old;
- •Regular menstrual period, menstrual cycle falls in the ranging from 28 to 30 days;
- •No pregnancy planning during taking study medication; use (or have their partner use) an acceptable method of birth control within the projected duration of the study ;
- •Subjects must sign ICF and agree for follow up.
排除标准
- •Genital cancer or other malignant tumor;
- •Adnexal masses≥5cm;
- •Uterine myoma≥3cm;
- •Suffering from cardiovascular, hepatic, renal or hematopoietic system disease or mental illness;
- •Receiving hormone therapy within 3 months prior to signing ICF;
- •Receiving surgical treatment for endometriosis within 3 months prior to signing ICF;
- •Subjects have a plan of pregnancy, being pregnant, breast-feeding during recent 3 months.
研究组 & 干预措施
Sanjie analgesic capsule
every 4 capsules , 3 times a day, on the first day of menstruation to start taking, taking three consecutive menstrual cycle.
干预措施: Sanjie analgesic capsule (Drug)
placebo
every 4 capsules, 3 times a day, on the first day of menstruation to start taking, taking three consecutive menstrual cycle.
干预措施: placebo (Drug)
结局指标
主要结局
dysmenorrhea
时间窗: Baseline, 1,2,3,4 menstrual cycle
次要结局
- change of Signs(Pelvic-tenderness Tubercle )(baseline，1,2,3,4 menstrual cycle)
- the size of uterus and endometriosis cyst(baseline,3,4 menstrual cycle)
- change of Menstrual cycle and quantity(baseline，1,2,3,4 menstrual cycle)
- change of serum CA125(baseline,3,4 menstrual cycle)
- change of SF-36 score(Baseline,3 menstrual cycle)
- Safety assessments will be based on electrocardiogram, physical examinations, and clinical laboratory tests(Baseline,3 menstrual cycle)
- change of Symptom (CPP Dyspareunia Defecate-pain Anal-bulge )(baseline，1,2,3,4 menstrual cycle)
- change of serum endocrinological hormone(baseline,3,4 menstrual cycle)
- Safety assessments will be based on adverse event reports(1,2,3 menstrual cycle)