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

Jiangsu Kanion Pharmaceutical

Status and phase

Unknown

Phase 4

Conditions

Dysmenorrhea

Treatments

Drug: placebo

Drug: Sanjie analgesic capsule

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02031523

NO.2-20130301

Details and patient eligibility

About

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.

Full description

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.

Enrollment

400 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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.