Clinical trial NCT02929420: A Clinical Study on the Efficacy and Safety of the Treatment of Hyperplasia of Mammary Glands With Xiaoru Sanjie Capsule
Official title: A Multicenter, Randomized, Open, Parallel Controlled Clinical Study on the Efficacy and Safety of the Treatment of Cyclomastopathy With Xiaoru Sanjie Capsule
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Fibrocystic Disease of Breast
Keywords: Multicenter
randomized
open
parallel controlled
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2016-10-11
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the size of breast lumps
timeFrame: after 30 days' treatment
measure: the size of breast lumps
timeFrame: after 60 days' treatment
measure: the size of breast lumps
timeFrame: after 90 days' treatment
measure: the scope of breast lumps
timeFrame: after 30 days' treatment
measure: the scope of breast lumps
timeFrame: after 60 days' treatment
measure: the scope of breast lumps
timeFrame: after 90 days' treatment
measure: the hardness of breast lumps
timeFrame: after 30 days' treatment
measure: the hardness of breast lumps
timeFrame: after 60 days' treatment
measure: the hardness of breast lumps
timeFrame: after 90 days' treatment
measure: pain of breast
timeFrame: after 30 days' treatment
measure: pain of breast
timeFrame: after 60 days' treatment
measure: pain of breast
timeFrame: after 90 days' treatment
Secondary outcomes:
measure: all adverse reactions after taking Xiaoru Sanjie capsule
timeFrame: after 30 days' treatment
measure: all adverse reactions after taking Xiaoru Sanjie capsule
timeFrame: after 60 days' treatment
measure: all adverse reactions after taking Xiaoru Sanjie capsule
timeFrame: after 90 days' treatment
measure: the level of estrogen
timeFrame: after 30 days' treatment
measure: the level of estrogen
timeFrame: after 60 days' treatment
measure: the level of estrogen
timeFrame: after 90 days' treatment
measure: the level of progestin
timeFrame: after 30 days' treatment
measure: the level of progestin
timeFrame: after 60 days' treatment
measure: the level of progestin
timeFrame: after 90 days' treatment
measure: the level of prolactin
timeFrame: after 30 days' treatment
measure: the level of prolactin
timeFrame: after 60 days' treatment
measure: the level of prolactin
timeFrame: after 90 days' treatment
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Yu Ren
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Yu Ren, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: