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

Phase 4

• Conditions: Fibrocystic Disease of Breast
• Interventions: Drug: Xiaoru Sanjie capsules; Drug: Xiao Yao pills

• Registration Number: NCT02929420
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

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

Detailed Description

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

Study Timeline

• Status Verified: 2016-08
• Study First Submitted: 2016-08-23
• Study Start: 2016-10
• Study First Submitted QC: 2016-10-07
• Last Update Submitted: 2016-10-07
• Study First Posted: 2016-10-11
• Last Update Posted: 2016-10-11
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 600

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xiaoru Sanjie capsules	Xiaoru Sanjie capsules	a new recipe of traditional chinese medicine； Xiaoru Sanjie capsules,three pills every time,three time a day,PO, last three months.
Xiao Yao pills	Xiao Yao pills	a kind of traditional chinese medicine that is efficient and safe to treat hyperplasia of mammary glands. Xiaoyao pills,three pills every time,three time a day,PO,last three months.

Primary Outcome Measures

Name	Time	Method
the size of breast lumps	after 90 days' treatment	Assess the size of breast lumps by breast ultrasonography or breast molybdenum target.
the scope of breast lumps	after 90 days' treatment	Assess the scope of breast lumps by breast ultrasonography or breast molybdenum target.
the hardness of breast lumps	after 90 days' treatment	Assess the hardness of breast lumps by breast ultrasonography or breast molybdenum target.
pain of breast	after 90 days' treatment	According to hyperplasia of mammary glands efficacy appraisal standard of 2002 china association of chinese medicine surgery branch.

Secondary Outcome Measures

Name	Time	Method
all adverse reactions after taking Xiaoru Sanjie capsule	after 90 days' treatment	Number of Participants with different adverse reactions after taking treatment.
the level of estrogen	after 90 days' treatment
the level of progestin	after 90 days' treatment
the level of prolactin	after 90 days' treatment

Trial Locations

Locations (1)

Yu Ren; 🇨🇳 Xi'an, Shaanxi, China