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

Primary Purpose

Dysmenorrhea

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Sanjie analgesic capsule
placebo
Sponsored by
Jiangsu Kanion Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysmenorrhea focused on measuring endometriosis, dysmenorrhea, Sanjie analgesic capsule, effect/safety

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing ChaoYang HospitalRecruiting
  • Beijing Obstetrics and Gynecology Hospital,Capital Medical UniversityRecruiting
  • Peking University First HospitalRecruiting
  • Peking Union Medical College HospitalRecruiting
  • The General Hospital of People's Liberation ArmyRecruiting
  • Hubei Provincal Hospital of TCMRecruiting
  • The First Hospital of Hunan University of chinese MedicineRecruiting
  • The Maternal and Child Health Hospital of Hunan ProvinceRecruiting
  • Shengjing Hospital of China Medical UniversityRecruiting
  • Jinan municipal hospital of Traditional Chinese MedicineRecruiting
  • The Second Hospital of Shandong University of Traditional Chinese MedicineRecruiting
  • Obstetrics and Gynecology Hospital of Fudan UniversityRecruiting
  • Women's Hospital School Of Medicine Zhejiang UniversityRecruiting
  • Guangxing Hospital Of Zhejiang Chinese Medicine UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Sanjie analgesic capsule

placebo

Arm Description

every 4 capsules , 3 times a day, on the first day of menstruation to start taking, taking three consecutive menstrual cycle.

every 4 capsules, 3 times a day, on the first day of menstruation to start taking, taking three consecutive menstrual cycle.

Outcomes

Primary Outcome Measures

dysmenorrhea

Secondary Outcome Measures

change of Symptom (CPP Dyspareunia Defecate-pain Anal-bulge )
change of Signs(Pelvic-tenderness Tubercle )
change of Menstrual cycle and quantity
change of serum CA125
the size of uterus and endometriosis cyst
change of serum endocrinological hormone
the content of FSH, LH, E2, PRL, P, T
change of SF-36 score
Safety assessments will be based on electrocardiogram, physical examinations, and clinical laboratory tests
Safety assessments will be based on adverse event reports

Full Information

First Posted
December 16, 2013
Last Updated
November 18, 2014
Sponsor
Jiangsu Kanion Pharmaceutical Co., Ltd
Collaborators
Beijing Bionovo Medicine Development Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02031523
Brief Title
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

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Kanion Pharmaceutical Co., Ltd
Collaborators
Beijing Bionovo Medicine Development Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea
Keywords
endometriosis, dysmenorrhea, Sanjie analgesic capsule, effect/safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sanjie analgesic capsule
Arm Type
Active Comparator
Arm Description
every 4 capsules , 3 times a day, on the first day of menstruation to start taking, taking three consecutive menstrual cycle.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
every 4 capsules, 3 times a day, on the first day of menstruation to start taking, taking three consecutive menstrual cycle.
Intervention Type
Drug
Intervention Name(s)
Sanjie analgesic capsule
Other Intervention Name(s)
Jiangsu Kanion Pharmaceutical Co.,Ltd
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
Jiangsu Kanion Pharmaceutical Co.,Ltd
Intervention Description
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.
Primary Outcome Measure Information:
Title
dysmenorrhea
Time Frame
Baseline, 1,2,3,4 menstrual cycle
Secondary Outcome Measure Information:
Title
change of Symptom (CPP Dyspareunia Defecate-pain Anal-bulge )
Time Frame
baseline，1,2,3,4 menstrual cycle
Title
change of Signs(Pelvic-tenderness Tubercle )
Time Frame
baseline，1,2,3,4 menstrual cycle
Title
change of Menstrual cycle and quantity
Time Frame
baseline，1,2,3,4 menstrual cycle
Title
change of serum CA125
Time Frame
baseline,3,4 menstrual cycle
Title
the size of uterus and endometriosis cyst
Time Frame
baseline,3,4 menstrual cycle
Title
change of serum endocrinological hormone
Description
the content of FSH, LH, E2, PRL, P, T
Time Frame
baseline,3,4 menstrual cycle
Title
change of SF-36 score
Time Frame
Baseline,3 menstrual cycle
Title
Safety assessments will be based on electrocardiogram, physical examinations, and clinical laboratory tests
Time Frame
Baseline,3 menstrual cycle
Title
Safety assessments will be based on adverse event reports
Time Frame
1,2,3 menstrual cycle

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lang Jinghe, Doctor
Organizational Affiliation
Beijing Union Medical College Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing ChaoYang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhang Zhenyu, M.D.
Email
zhengyuzhang2000@yahoo.com
First Name & Middle Initial & Last Name & Degree
Zhang Zhenyu, M.D.
Facility Name
Beijing Obstetrics and Gynecology Hospital,Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100026
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Duan Hua, M.D.
Email
duanhua888@163.com
First Name & Middle Initial & Last Name & Degree
Duan Hua, M.D.
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhou Yingfang, M.D.
Email
zhouyf8853@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Zhou Yingfang, M.D.
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leng Jinhua, M.D.
Email
lengjenny@vip.sina.com
First Name & Middle Initial & Last Name & Degree
Lang Jinghe, Doctor
Facility Name
The General Hospital of People's Liberation Army
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guan Zheng, Master
Email
GZ9332@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Guan Zheng, Master
Facility Name
Hubei Provincal Hospital of TCM
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhou zhongming
Email
379327931@qq.com
First Name & Middle Initial & Last Name & Degree
Zhou Zhongming
Facility Name
The First Hospital of Hunan University of chinese Medicine
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Jie
Email
379327931@qq.com
First Name & Middle Initial & Last Name & Degree
Lin Jie
Facility Name
The Maternal and Child Health Hospital of Hunan Province
City
Changsha
State/Province
Hunan
ZIP/Postal Code
41008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gong Yingping
Phone
13973139188
First Name & Middle Initial & Last Name & Degree
Gong Yingping
Facility Name
Shengjing Hospital of China Medical University
City
Shen yang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhang Shulan, Master
Email
zsl0909@sina.com
First Name & Middle Initial & Last Name & Degree
Zhang Shulan, Master
Facility Name
Jinan municipal hospital of Traditional Chinese Medicine
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tang Ye
Phone
13589018957
First Name & Middle Initial & Last Name & Degree
Tang Ye
Facility Name
The Second Hospital of Shandong University of Traditional Chinese Medicine
City
Jinan
State/Province
Shandong
ZIP/Postal Code
25001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sun Wei
Email
839580089@qq.com
First Name & Middle Initial & Last Name & Degree
Sun Wei
Facility Name
Obstetrics and Gynecology Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhang Shaofen, Bachelor
Email
zhangshaofen@163.com
First Name & Middle Initial & Last Name & Degree
Zhang Shaofen, Bachelor
Facility Name
Women's Hospital School Of Medicine Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Jun, Bachelor
Email
linjun@zju.edu.cn
First Name & Middle Initial & Last Name & Degree
Lin Jun, Bachelor
Facility Name
Guangxing Hospital Of Zhejiang Chinese Medicine University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
31007
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhang Qin
Email
Zhqin@zjwh.gov.cn
First Name & Middle Initial & Last Name & Degree
Zhang Qin

12. IPD Sharing Statement

Learn more about this trial

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

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