The purpose of this study is to evaluate the efficacy and safety of Xiaoru Sanjie capsule in the treatment of cyclomastopathy.
This is a multicenter, randomized, open and parallel controlled clinical study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
600
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.
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.
Yu Ren
Xi'an, Shaanxi, China
RECRUITINGthe size of breast lumps
Assess the size of breast lumps by breast ultrasonography or breast molybdenum target.
Time frame: after 30 days' treatment
the size of breast lumps
Assess the size of breast lumps by breast ultrasonography or breast molybdenum target.
Time frame: after 60 days' treatment
the size of breast lumps
Assess the size of breast lumps by breast ultrasonography or breast molybdenum target.
Time frame: after 90 days' treatment
the scope of breast lumps
Assess the scope of breast lumps by breast ultrasonography or breast molybdenum target.
Time frame: after 30 days' treatment
the scope of breast lumps
Assess the scope of breast lumps by breast ultrasonography or breast molybdenum target.
Time frame: after 60 days' treatment
the scope of breast lumps
Assess the scope of breast lumps by breast ultrasonography or breast molybdenum target.
Time frame: after 90 days' treatment
the hardness of breast lumps
Assess the hardness of breast lumps by breast ultrasonography or breast molybdenum target.
Time frame: after 30 days' treatment
the hardness of breast lumps
Assess the hardness of breast lumps by breast ultrasonography or breast molybdenum target.
Time frame: after 60 days' treatment
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the hardness of breast lumps
Assess the hardness of breast lumps by breast ultrasonography or breast molybdenum target.
Time frame: after 90 days' treatment
pain of breast
According to hyperplasia of mammary glands efficacy appraisal standard of 2002 china association of chinese medicine surgery branch.
Time frame: after 30 days' treatment
pain of breast
According to hyperplasia of mammary glands efficacy appraisal standard of 2002 china association of chinese medicine surgery branch.
Time frame: after 60 days' treatment
pain of breast
According to hyperplasia of mammary glands efficacy appraisal standard of 2002 china association of chinese medicine surgery branch.
Time frame: after 90 days' treatment
all adverse reactions after taking Xiaoru Sanjie capsule
Number of Participants with different adverse reactions after taking treatment.
Time frame: after 30 days' treatment
all adverse reactions after taking Xiaoru Sanjie capsule
Number of Participants with different adverse reactions after taking treatment.
Time frame: after 60 days' treatment
all adverse reactions after taking Xiaoru Sanjie capsule
Number of Participants with different adverse reactions after taking treatment.
Time frame: after 90 days' treatment
the level of estrogen
Time frame: after 30 days' treatment
the level of estrogen
Time frame: after 60 days' treatment
the level of estrogen
Time frame: after 90 days' treatment
the level of progestin
Time frame: after 30 days' treatment
the level of progestin
Time frame: after 60 days' treatment
the level of progestin
Time frame: after 90 days' treatment
the level of prolactin
Time frame: after 30 days' treatment
the level of prolactin
Time frame: after 60 days' treatment
the level of prolactin
Time frame: after 90 days' treatment