A Clinical Study on the Efficacy and Safety of the Treatment of Hyperplasia of Mammary Glands With Xiaoru Sanjie Capsule

Fibrocystic Disease of Breast Clinical Trial

Official title:

A Multicenter, Randomized, Open, Parallel Controlled Clinical Study on the Efficacy and Safety of the Treatment of Cyclomastopathy With Xiaoru Sanjie Capsule

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02929420
• Other study ID #: ry-2016-08
• Status: Recruiting
• Phase: Phase 4
• First received: August 23, 2016
• Last updated: October 7, 2016
• Start date: October 2016
• Est. completion date: December 2017

Study information

• Verified date: August 2016
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Yu Ren
• Phone: 13700222161
• Email: renyyyyy[@]126.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of Xiaoru Sanjie capsule in the treatment of cyclomastopathy.

Description:

This is a multicenter, randomized, open and parallel controlled clinical study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18-65 years old female patients with cyclomastopathy who signed a written informed consent.

• The subjects voluntarily entered the clinical observation whom are hospitalized patients or outpatients with good compliance.

• They have specific symptoms, such as distending pain of the breast, stabbing pain, dull pain and radiating pain.

• They have specific physical sign, for example, we can touch block gland, granular, nodular or cord like glands and etc..

• Breast ultrasound or molybdenum target show I-III class by Breast Imaging Reporting and Data System.

Exclusion Criteria:

• Women who are pregnant or lactating, and who has the history of periarthritis of shoulder.

• Excluding breast fibrocellular tumor, breast cancer and other breast diseases.

• Patients with poor self coordination, mentally retarded patients, or have cardiovascular and cerebrovascular disease, severe organic disease, as well as the hematopoietic system disease or mental illness.

• Be judged as over middle degree depression by the Hamilton's depression scale.

• Allergic constitution patients, and people who are allergic to a variety of drugs.

• Any medical history which may interfere with the test results or increase the risk of patients according to the investigators.

• Patients who have received treatment of other diseases, and those treatment methods and targets may have an impact on the indicators of this study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Diseases
• Cystic Fibrosis
• Fibrocystic Disease of Breast

Intervention

Drug:
• Xiaoru Sanjie capsules
Oral medication for a total of 90 days. According to the instructions, P.O., three times a day, each time three tablets, take a month as a treatment course, continuous use of 3 courses.
• Xiao Yao pills
Oral medication for a total of 90 days. According to the instructions, P.O., three times a day, each time three tablets, take a month as a treatment course, continuous use of 3 courses.

Locations

Country	Name	City	State
China	Yu Ren	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the size of breast lumps	Assess the size of breast lumps by breast ultrasonography or breast molybdenum target.	after 30 days' treatment	No
Primary	the size of breast lumps	Assess the size of breast lumps by breast ultrasonography or breast molybdenum target.	after 60 days' treatment	No
Primary	the size of breast lumps	Assess the size of breast lumps by breast ultrasonography or breast molybdenum target.	after 90 days' treatment	No
Primary	the scope of breast lumps	Assess the scope of breast lumps by breast ultrasonography or breast molybdenum target.	after 30 days' treatment	No
Primary	the scope of breast lumps	Assess the scope of breast lumps by breast ultrasonography or breast molybdenum target.	after 60 days' treatment	No
Primary	the scope of breast lumps	Assess the scope of breast lumps by breast ultrasonography or breast molybdenum target.	after 90 days' treatment	No
Primary	the hardness of breast lumps	Assess the hardness of breast lumps by breast ultrasonography or breast molybdenum target.	after 30 days' treatment	No
Primary	the hardness of breast lumps	Assess the hardness of breast lumps by breast ultrasonography or breast molybdenum target.	after 60 days' treatment	No
Primary	the hardness of breast lumps	Assess the hardness of breast lumps by breast ultrasonography or breast molybdenum target.	after 90 days' treatment	No
Primary	pain of breast	According to hyperplasia of mammary glands efficacy appraisal standard of 2002 china association of chinese medicine surgery branch.	after 30 days' treatment	No
Primary	pain of breast	According to hyperplasia of mammary glands efficacy appraisal standard of 2002 china association of chinese medicine surgery branch.	after 60 days' treatment	No
Primary	pain of breast	According to hyperplasia of mammary glands efficacy appraisal standard of 2002 china association of chinese medicine surgery branch.	after 90 days' treatment	No
Secondary	all adverse reactions after taking Xiaoru Sanjie capsule	Number of Participants with different adverse reactions after taking treatment.	after 30 days' treatment	No
Secondary	all adverse reactions after taking Xiaoru Sanjie capsule	Number of Participants with different adverse reactions after taking treatment.	after 60 days' treatment	No
Secondary	all adverse reactions after taking Xiaoru Sanjie capsule	Number of Participants with different adverse reactions after taking treatment.	after 90 days' treatment	No
Secondary	the level of estrogen		after 30 days' treatment	No
Secondary	the level of estrogen		after 60 days' treatment	No
Secondary	the level of estrogen		after 90 days' treatment	No
Secondary	the level of progestin		after 30 days' treatment	No
Secondary	the level of progestin		after 60 days' treatment	No
Secondary	the level of progestin		after 90 days' treatment	No
Secondary	the level of prolactin		after 30 days' treatment	No
Secondary	the level of prolactin		after 60 days' treatment	No
Secondary	the level of prolactin		after 90 days' treatment	No