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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02031523
Other study ID # NO.2-20130301
Secondary ID
Status Recruiting
Phase Phase 4
First received December 16, 2013
Last updated November 18, 2014
Start date October 2013
Est. completion date December 2015

Study information

Verified date December 2013
Source Jiangsu Kanion Pharmaceutical Co., Ltd
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date December 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design

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


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
China Beijing ChaoYang Hospital Beijing Beijing
China Beijing Obstetrics and Gynecology Hospital,Capital Medical University Beijing Beijing
China Peking Union Medical College Hospital Beijing Beijing
China Peking University First Hospital Beijing Beijing
China The General Hospital of People's Liberation Army Beijing Beijing
China The First Hospital of Hunan University of chinese Medicine Changsha Hunan
China The Maternal and Child Health Hospital of Hunan Province Changsha Hunan
China Guangxing Hospital Of Zhejiang Chinese Medicine University Hangzhou Zhejiang
China Women's Hospital School Of Medicine Zhejiang University Hangzhou Zhejiang
China Jinan municipal hospital of Traditional Chinese Medicine Jinan Shandong
China The Second Hospital of Shandong University of Traditional Chinese Medicine Jinan Shandong
China Obstetrics and Gynecology Hospital of Fudan University Shanghai Shanghai
China Shengjing Hospital of China Medical University Shen yang Liaoning
China Hubei Provincal Hospital of TCM Wuhan Hubei

Sponsors (2)

Lead Sponsor Collaborator
Jiangsu Kanion Pharmaceutical Co., Ltd Beijing Bionovo Medicine Development Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary dysmenorrhea Baseline, 1,2,3,4 menstrual cycle No
Secondary change of Symptom (CPP Dyspareunia Defecate-pain Anal-bulge ) baseline,1,2,3,4 menstrual cycle No
Secondary change of Signs(Pelvic-tenderness Tubercle ) baseline,1,2,3,4 menstrual cycle No
Secondary change of Menstrual cycle and quantity baseline,1,2,3,4 menstrual cycle No
Secondary change of serum CA125 baseline,3,4 menstrual cycle No
Secondary the size of uterus and endometriosis cyst baseline,3,4 menstrual cycle No
Secondary change of serum endocrinological hormone the content of FSH, LH, E2, PRL, P, T baseline,3,4 menstrual cycle No
Secondary change of SF-36 score Baseline,3 menstrual cycle No
Secondary Safety assessments will be based on electrocardiogram, physical examinations, and clinical laboratory tests Baseline,3 menstrual cycle Yes
Secondary Safety assessments will be based on adverse event reports 1,2,3 menstrual cycle Yes
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