Multi-center Clinical Trials of Sanjie Analgesic Capsule in Treating Endometriosis
- Registration Number
- NCT02031523
- Lead Sponsor
- Jiangsu Kanion Pharmaceutical Co., Ltd
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 400
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo placebo every 4 capsules, 3 times a day, on the first day of menstruation to start taking, taking three consecutive menstrual cycle. Sanjie analgesic capsule Sanjie analgesic capsule every 4 capsules , 3 times a day, on the first day of menstruation to start taking, taking three consecutive menstrual cycle.
- Primary Outcome Measures
Name Time Method dysmenorrhea Baseline, 1,2,3,4 menstrual cycle
- Secondary Outcome Measures
Name Time Method 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 the content of FSH, LH, E2, PRL, P, T
Safety assessments will be based on adverse event reports 1,2,3 menstrual cycle
Trial Locations
- Locations (14)
Beijing ChaoYang Hospital
🇨🇳Beijing, Beijing, China
The General Hospital of People's Liberation Army
🇨🇳Beijing, Beijing, China
The Maternal and Child Health Hospital of Hunan Province
🇨🇳Changsha, Hunan, China
The Second Hospital of Shandong University of Traditional Chinese Medicine
🇨🇳Jinan, Shandong, China
Women's Hospital School Of Medicine Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
Jinan municipal hospital of Traditional Chinese Medicine
🇨🇳Jinan, Shandong, China
Obstetrics and Gynecology Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China
Beijing Obstetrics and Gynecology Hospital,Capital Medical University
🇨🇳Beijing, Beijing, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
The First Hospital of Hunan University of chinese Medicine
🇨🇳Changsha, Hunan, China
Shengjing Hospital of China Medical University
🇨🇳Shen yang, Liaoning, China
Hubei Provincal Hospital of TCM
🇨🇳Wuhan, Hubei, China
Guangxing Hospital Of Zhejiang Chinese Medicine University
🇨🇳Hangzhou, Zhejiang, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China