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

November 18, 2014 updated by: Jiangsu Kanion Pharmaceutical Co., Ltd

A Randomized, Double-blind, Placebo-controlled Post-marketing Study to Assess the Treatment Effect of Sanjie Analgesic Capsule in Treating Endometriosis - Associated Pain

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
        • Principal Investigator:
          • Lang Jinghe, Doctor
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:
        • Principal Investigator:
          • Zhou Yingfang, M.D.
      • Beijing, Beijing, China, 100020
        • Recruiting
        • Beijing ChaoYang Hospital
        • Contact:
        • Principal Investigator:
          • Zhang Zhenyu, M.D.
      • Beijing, Beijing, China, 100026
        • Recruiting
        • Beijing Obstetrics and Gynecology Hospital,Capital Medical University
        • Contact:
        • Principal Investigator:
          • Duan Hua, M.D.
      • Beijing, Beijing, China, 100853
        • Recruiting
        • The General Hospital of People's Liberation Army
        • Contact:
        • Principal Investigator:
          • Guan Zheng, Master
    • Hubei
      • Wuhan, Hubei, China, 430061
        • Recruiting
        • Hubei Provincal Hospital of TCM
        • Contact:
        • Principal Investigator:
          • Zhou Zhongming
    • Hunan
      • Changsha, Hunan, China, 410000
        • Recruiting
        • The First Hospital of Hunan University of Chinese Medicine
        • Contact:
        • Principal Investigator:
          • Lin Jie
      • Changsha, Hunan, China, 41008
        • Recruiting
        • The Maternal and Child Health Hospital of Hunan Province
        • Contact:
          • Gong Yingping
          • Phone Number: 13973139188
        • Principal Investigator:
          • Gong Yingping
    • Liaoning
      • Shen yang, Liaoning, China, 110004
        • Recruiting
        • ShengJing Hospital Of China Medical University
        • Contact:
        • Principal Investigator:
          • Zhang Shulan, Master
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Jinan municipal hospital of Traditional Chinese Medicine
        • Contact:
          • Tang Ye
          • Phone Number: 13589018957
        • Principal Investigator:
          • Tang Ye
      • Jinan, Shandong, China, 25001
        • Recruiting
        • The Second Hospital of Shandong University of Traditional Chinese Medicine
        • Contact:
        • Principal Investigator:
          • Sun Wei
    • Shanghai
      • Shanghai, Shanghai, China, 200011
        • Recruiting
        • Obstetrics and Gynecology Hospital of Fudan University
        • Contact:
        • Principal Investigator:
          • Zhang Shaofen, Bachelor
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006
        • Recruiting
        • Women's Hospital School of Medicine Zhejiang University
        • Contact:
        • Principal Investigator:
          • Lin Jun, Bachelor
      • Hangzhou, Zhejiang, China, 31007
        • Recruiting
        • Guangxing Hospital Of Zhejiang Chinese Medicine University
        • Contact:
        • Principal Investigator:
          • Zhang Qin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Jiangsu Kanion Pharmaceutical Co.,Ltd

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
dysmenorrhea
Time Frame: Baseline, 1,2,3,4 menstrual cycle
Baseline, 1,2,3,4 menstrual cycle

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of Symptom (CPP Dyspareunia Defecate-pain Anal-bulge )
Time Frame: baseline，1,2,3,4 menstrual cycle
baseline，1,2,3,4 menstrual cycle
change of Signs(Pelvic-tenderness Tubercle )
Time Frame: baseline，1,2,3,4 menstrual cycle
baseline，1,2,3,4 menstrual cycle
change of Menstrual cycle and quantity
Time Frame: baseline，1,2,3,4 menstrual cycle
baseline，1,2,3,4 menstrual cycle
change of serum CA125
Time Frame: baseline,3,4 menstrual cycle
baseline,3,4 menstrual cycle
the size of uterus and endometriosis cyst
Time Frame: baseline,3,4 menstrual cycle
baseline,3,4 menstrual cycle
change of serum endocrinological hormone
Time Frame: baseline,3,4 menstrual cycle
the content of FSH, LH, E2, PRL, P, T
baseline,3,4 menstrual cycle
change of SF-36 score
Time Frame: Baseline,3 menstrual cycle
Baseline,3 menstrual cycle
Safety assessments will be based on electrocardiogram, physical examinations, and clinical laboratory tests
Time Frame: Baseline,3 menstrual cycle
Baseline,3 menstrual cycle
Safety assessments will be based on adverse event reports
Time Frame: 1,2,3 menstrual cycle
1,2,3 menstrual cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Kanion Pharmaceutical Co., Ltd

Collaborators

Beijing Bionovo Medicine Development Co., Ltd.

Investigators

  • Principal Investigator: Lang Jinghe, Doctor, Beijing Union Medical College Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

October 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

December 16, 2013

First Submitted That Met QC Criteria

January 8, 2014

First Posted (Estimate)

January 9, 2014

Study Record Updates

Last Update Posted (Estimate)

November 19, 2014

Last Update Submitted That Met QC Criteria

November 18, 2014

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NO.2-20130301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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