Clinical Trial: A Clinical Study on the Efficacy and Safety of the Treatment of Hyperplasia of Mammary Glands With Xiaoru Sanjie Capsule
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Multicenter, Randomized, Open, Parallel Controlled Clinical Study on the Efficacy and Safety of the Treatment of Cyclomastopathy With Xiaoru Sanjie Capsule
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of Xiaoru Sanjie capsule in the treatment of cyclomastopathy.
Detailed Summary: This is a multicenter, randomized, open and parallel controlled clinical study.
Sponsor: First Affiliated Hospital Xi'an Jiaotong University
Current Primary Outcome:
- the size of breast lumps [ Time Frame: after 30 days' treatment ]Assess the size of breast lumps by breast ultrasonography or breast molybdenum target.
- the size of breast lumps [ Time Frame: after 60 days' treatment ]Assess the size of breast lumps by breast ultrasonography or breast molybdenum target.
- the size of breast lumps [ Time Frame: after 90 days' treatment ]Assess the size of breast lumps by breast ultrasonography or breast molybdenum target.
- the scope of breast lumps [ Time Frame: after 30 days' treatment ]Assess the scope of breast lumps by breast ultrasonography or breast molybdenum target.
- the scope of breast lumps [ Time Frame: after 60 days' treatment ]Assess the scope of breast lumps by breast ultrasonography or breast molybdenum target.
- the scope of breast lumps [ Time Frame: after 90 days' treatment ]Assess the scope of breast lumps by breast ultrasonography or breast molybdenum target.
- the hardness of breast lumps [ Time Frame: after 30 days' treatment ]Assess the hardness of breast lumps by breast ultrasonography or breast molybdenum target.
- the hardness of breast lumps [ Time Frame: after 60 days'
Original Primary Outcome: Same as current
Current Secondary Outcome:
- all adverse reactions after taking Xiaoru Sanjie capsule [ Time Frame: after 30 days' treatment ]Number of Participants with different adverse reactions after taking treatment.
- all adverse reactions after taking Xiaoru Sanjie capsule [ Time Frame: after 60 days' treatment ]Number of Participants with different adverse reactions after taking treatment.
- all adverse reactions after taking Xiaoru Sanjie capsule [ Time Frame: after 90 days' treatment ]Number of Participants with different adverse reactions after taking 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 ]
Original Secondary Outcome: Same as current
Information By: First Affiliated Hospital Xi'an Jiaotong University
Dates:
Date Received: August 23, 2016
Date Started: October 2016
Date Completion: December 2017
Last Updated: October 7, 2016
Last Verified: August 2016
- all adverse reactions after taking Xiaoru Sanjie capsule [ Time Frame: after 30 days' treatment ]