Dysmenorrhea
Conditions
Keywords
endometriosis, dysmenorrhea, Sanjie analgesic capsule, effect/safety
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.
Interventions
DRUGSanjie analgesic capsule
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.
DRUGplacebo
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.
Sponsors
Beijing Bionovo Medicine Development Co., Ltd.
Jiangsu Kanion Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| dysmenorrhea | Baseline, 1,2,3,4 menstrual cycle |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change of Signs(Pelvic-tenderness Tubercle ) | baseline，1,2,3,4 menstrual cycle | — |
| change of Menstrual cycle and quantity | baseline，1,2,3,4 menstrual cycle | — |
| change of serum CA125 | baseline,3,4 menstrual cycle | — |
| the size of uterus and endometriosis cyst | baseline,3,4 menstrual cycle | — |
| change of Symptom (CPP Dyspareunia Defecate-pain Anal-bulge ) | baseline，1,2,3,4 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 | — |
| Safety assessments will be based on adverse event reports | 1,2,3 menstrual cycle | — |
| change of serum endocrinological hormone | baseline,3,4 menstrual cycle | the content of FSH, LH, E2, PRL, P, T |
Countries
China
Outcome results
None listed