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