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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
400
Oral, four each time, 3 times a day, on the first day of menstruation to start taking, taking three consecutive menstrual cycle.or follow the doctor's advice.
oral,four each time, 3 times a day, on the first day of menstruation to start taking, taking three consecutive menstrual cycle. Or Follow the doctor's advice.
Beijing ChaoYang Hospital
Beijing, Beijing Municipality, China
RECRUITINGBeijing Obstetrics and Gynecology Hospital,Capital Medical University
dysmenorrhea
Time frame: Baseline, 1,2,3,4 menstrual cycle
change of Symptom (CPP Dyspareunia Defecate-pain Anal-bulge )
Time frame: baseline,1,2,3,4 menstrual cycle
change of Signs(Pelvic-tenderness Tubercle )
Time frame: baseline,1,2,3,4 menstrual cycle
change of Menstrual cycle and quantity
Time frame: baseline,1,2,3,4 menstrual cycle
change of serum CA125
Time frame: baseline,3,4 menstrual cycle
the size of uterus and endometriosis cyst
Time frame: baseline,3,4 menstrual cycle
change of serum endocrinological hormone
the content of FSH, LH, E2, PRL, P, T
Time frame: baseline,3,4 menstrual cycle
change of SF-36 score
Time frame: Baseline,3 menstrual cycle
Safety assessments will be based on electrocardiogram, physical examinations, and clinical laboratory tests
Time frame: Baseline,3 menstrual cycle
Safety assessments will be based on adverse event reports
Time frame: 1,2,3 menstrual cycle
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Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
RECRUITINGPeking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe General Hospital of People's Liberation Army
Beijing, Beijing Municipality, China
RECRUITINGHubei Provincal Hospital of TCM
Wuhan, Hubei, China
RECRUITINGThe First Hospital of Hunan University of chinese Medicine
Changsha, Hunan, China
RECRUITINGThe Maternal and Child Health Hospital of Hunan Province
Changsha, Hunan, China
RECRUITINGShengjing Hospital of China Medical University
Shenyang, Liaoning, China
RECRUITINGJinan municipal hospital of Traditional Chinese Medicine
Jinan, Shandong, China
RECRUITING...and 4 more locations