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

Dysmenorrhea Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02031523
• Other study ID #: NO.2-20130301
• 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

• Dysmenorrhea
• Endometriosis

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