Multi-center Clinical Trials of Sanjie Analgesic Capsule in Treating Endometriosis

A Randomized, Double-blind, Placebo-controlled Post-marketing Study to Assess the Treatment Effect of Sanjie Analgesic Capsule in Treating Endometriosis - Associated Pain

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.

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.