Clinical trial NCT02031523: Multi-center Clinical Trials of Sanjie Analgesic Capsule in Treating Endometriosis
Official title: A Randomized, Double-blind, Placebo-controlled Post-marketing Study to Assess the Treatment Effect of Sanjie Analgesic Capsule in Treating Endometriosis - Associated Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dysmenorrhea
Keywords: endometriosis
dysmenorrhea
Sanjie analgesic capsule
effect/safety
Lead sponsor: Jiangsu Kanion Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Beijing Bionovo Medicine Development Co., Ltd.
First posted: 2014-01-09
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: dysmenorrhea
timeFrame: Baseline, 1,2,3,4 menstrual cycle
Secondary outcomes:
measure: change of Symptom (CPP Dyspareunia Defecate-pain Anal-bulge )
timeFrame: baseline，1,2,3,4 menstrual cycle
measure: change of Signs(Pelvic-tenderness Tubercle )
timeFrame: baseline，1,2,3,4 menstrual cycle
measure: change of Menstrual cycle and quantity
timeFrame: baseline，1,2,3,4 menstrual cycle
measure: change of serum CA125
timeFrame: baseline,3,4 menstrual cycle
measure: the size of uterus and endometriosis cyst
timeFrame: baseline,3,4 menstrual cycle
measure: change of serum endocrinological hormone
timeFrame: baseline,3,4 menstrual cycle
measure: change of SF-36 score
timeFrame: Baseline,3 menstrual cycle
measure: Safety assessments will be based on electrocardiogram, physical examinations, and clinical laboratory tests
timeFrame: Baseline,3 menstrual cycle
measure: Safety assessments will be based on adverse event reports
timeFrame: 1,2,3 menstrual cycle
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing ChaoYang Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Obstetrics and Gynecology Hospital,Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: The General Hospital of People's Liberation Army
state: Beijing
city: Wuhan
country: China
facility: Hubei Provincal Hospital of TCM
state: Hubei
city: Changsha
country: China
facility: The First Hospital of Hunan University of chinese Medicine
state: Hunan
city: Changsha
country: China
facility: The Maternal and Child Health Hospital of Hunan Province
state: Hunan
city: Shen yang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Jinan
country: China
facility: Jinan municipal hospital of Traditional Chinese Medicine
state: Shandong
city: Jinan
country: China
facility: The Second Hospital of Shandong University of Traditional Chinese Medicine
state: Shandong
city: Shanghai
country: China
facility: Obstetrics and Gynecology Hospital of Fudan University
state: Shanghai
city: Hangzhou
country: China
facility: Women's Hospital School Of Medicine Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Guangxing Hospital Of Zhejiang Chinese Medicine University
state: Zhejiang
Study officials:
affiliation: Beijing Union Medical College Hospital, Chinese Academy of Medical Sciences
name: Lang Jinghe, Doctor
role: PRINCIPAL_INVESTIGATOR
References: