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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Jiangsu Kanion Pharmaceutical Co.,Ltd
Sponsor:
Collaborator:
Beijing Bionovo Medicine Development Co., Ltd.
Information provided by (Responsible Party):
Jiangsu Kanion Pharmaceutical Co.,Ltd
ClinicalTrials.gov Identifier:
NCT02031523
First received: December 16, 2013
Last updated: June 23, 2014
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Dysmenorrhea
Drug: Sanjie analgesic capsule
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Jiangsu Kanion Pharmaceutical Co.,Ltd:

Primary Outcome Measures:
  • dysmenorrhea [ Time Frame: Baseline, 1,2,3,4 menstrual cycle ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change of Symptom (CPP Dyspareunia Defecate-pain Anal-bulge ) [ Time Frame: baseline,1,2,3,4 menstrual cycle ] [ Designated as safety issue: No ]
  • change of Signs(Pelvic-tenderness Tubercle ) [ Time Frame: baseline,1,2,3,4 menstrual cycle ] [ Designated as safety issue: No ]
  • change of Menstrual cycle and quantity [ Time Frame: baseline,1,2,3,4 menstrual cycle ] [ Designated as safety issue: No ]
  • change of serum CA125 [ Time Frame: baseline,3,4 menstrual cycle ] [ Designated as safety issue: No ]
  • the size of uterus and endometriosis cyst [ Time Frame: baseline,3,4 menstrual cycle ] [ Designated as safety issue: No ]
  • change of serum endocrinological hormone [ Time Frame: baseline,3,4 menstrual cycle ] [ Designated as safety issue: No ]
    the content of FSH, LH, E2, PRL, P, T

  • change of SF-36 score [ Time Frame: Baseline,3 menstrual cycle ] [ Designated as safety issue: No ]
  • Safety assessments will be based on electrocardiogram, physical examinations, and clinical laboratory tests [ Time Frame: Baseline,3 menstrual cycle ] [ Designated as safety issue: Yes ]
  • Safety assessments will be based on adverse event reports [ Time Frame: 1,2,3 menstrual cycle ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: October 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sanjie analgesic capsule
every 4 capsules , 3 times a day, on the first day of menstruation to start taking, taking three consecutive menstrual cycle.
Drug: Sanjie 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.
Other Name: Jiangsu Kanion Pharmaceutical Co.,Ltd
Placebo Comparator: placebo
every 4 capsules, 3 times a day, on the first day of menstruation to start taking, taking three consecutive menstrual cycle.
Drug: placebo
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.
Other Name: Jiangsu Kanion Pharmaceutical Co.,Ltd

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02031523

Locations
China, Beijing
Beijing Union Medical College Hospital,Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 100730
Contact: Leng Jinhua, M.D.       lengjenny@vip.sina.com   
Principal Investigator: Lang Jinghe, Doctor         
Peking University First Hospital Recruiting
Beijing, Beijing, China, 100034
Contact: Zhou Yingfang, M.D.       zhouyf8853@yahoo.com.cn   
Principal Investigator: Zhou Yingfang, M.D.         
The General Hospital of People's Liberation Army Recruiting
Beijing, Beijing, China, 100853
Contact: Guan Zheng, Master       GZ9332@yahoo.com.cn   
Principal Investigator: Guan Zheng, Master         
China-Japan Friendship Hospital Not yet recruiting
Beijing, Beijing, China, 100029
Contact: Ling Bin, M.D.       lingbin.ling@vip.sina.com   
Principal Investigator: Ling Bin, M.D.         
Beijing Obstetrics and Gynecology Hospital,Capital Medical University Recruiting
Beijing, Beijing, China, 100026
Contact: Duan Hua, M.D.       duanhua888@163.com   
Principal Investigator: Duan Hua, M.D.         
Beijing ChaoYang Hospital Recruiting
Beijing, Beijing, China, 100020
Contact: Zhang Zhenyu, M.D.       zhengyuzhang2000@yahoo.com   
Principal Investigator: Zhang Zhenyu, M.D.         
China, Hubei
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology Not yet recruiting
Wuhan, Hubei, China, 430030
Contact: Wang Shixuan, M.D.       sxwang@tjh.tjmu.edu.cn   
Principal Investigator: Wang Shixuan, M.D.         
Hubei Provincal Hospital of TCM Recruiting
Wuhan, Hubei, China, 430061
Contact: Zhou zhongming       379327931@qq.com   
Principal Investigator: Zhou Zhongming         
China, Hunan
The Second Xiangya Hospital of Central South University Not yet recruiting
Changsha, Hunan, China, 410011
Contact: Fang Xiaoling, M.D.       fxlfxl0510@126.com   
Principal Investigator: Fang Xiaoling, M.D.         
The First Hospital of Hunan University of chinese Medicine Recruiting
Changsha, Hunan, China, 410000
Contact: Lin Jie       379327931@qq.com   
Principal Investigator: Lin Jie         
China, Liaoning
Shengjing Hospital of China Medical University Recruiting
Shen yang, Liaoning, China, 110004
Contact: Zhang Shulan, Master       zsl0909@sina.com   
Principal Investigator: Zhang Shulan, Master         
Liaoning University Of Traditional Chinese Medicine Recruiting
Shenyang, Liaoning, China, 110032
Contact: Wang Xin       tmwxtsy@sohu.com   
Principal Investigator: Wang Xin         
China, Shanghai
Obstetrics and Gynecology Hospital of Fudan University Recruiting
Shanghai, Shanghai, China, 200011
Contact: Zhang Shaofen, Bachelor       zhangshaofen@163.com   
Principal Investigator: Zhang Shaofen, Bachelor         
China, Zhejiang
Women's Hospital School Of Medicine Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310006
Contact: Lin Jun, Bachelor       linjun@zju.edu.cn   
Principal Investigator: Lin Jun, Bachelor         
Hangzhou Traditional Chinese Medical Hospital Recruiting
Hangzhou, Zhejiang, China, 310007
Contact: Zhang qin       Zhqin@zjwh.gov.cn   
Principal Investigator: Zhang Qin         
Sponsors and Collaborators
Jiangsu Kanion Pharmaceutical Co.,Ltd
Beijing Bionovo Medicine Development Co., Ltd.
Investigators
Principal Investigator: Lang Jinghe, Doctor Beijing Union Medical College Hospital, Chinese Academy of Medical Sciences
  More Information

No publications provided

Responsible Party: Jiangsu Kanion Pharmaceutical Co.,Ltd
ClinicalTrials.gov Identifier: NCT02031523     History of Changes
Other Study ID Numbers: NO.2-20130301
Study First Received: December 16, 2013
Last Updated: June 23, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Jiangsu Kanion Pharmaceutical Co.,Ltd:
endometriosis
dysmenorrhea
Sanjie analgesic capsule
effect/safety

Additional relevant MeSH terms:
Dysmenorrhea
Endometriosis
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Signs and Symptoms
Genital Diseases, Female
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014