Clinical Trial: Clinical Trial of Experienced Chinese Herbal Formulas on Different Types of Precocious Puberty

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Efficacy of Experienced Chinese Herbal Formulas for the Treatment of Different Types of Precocious Puberty: A Single-blinded Randomized Controlled Trial

Brief Summary: Due to various complex factors, the incidence of precocious puberty is increasing rapidly. It severely threatens physical and mental health of children. It's urgent to explore effective ways to control the disease.

Detailed Summary: In the research, 138 precocious puberty children are randomly divided into the Ziyinxiehuo granules group (69 cases) and Zishenqinggan granules group(69 cases). Patients in Ziyinxiehuo granules group are treated with a series of experienced chinese herbal formulas, whereas the Zishenqinggan granules group received with different series of experienced chinese herbal formulas.
Sponsor: Children's Hospital of Fudan University

Current Primary Outcome: Change in some index of B type ultrasonography ( uterus,ovary,follicle ) [ Time Frame: 3 months, 6months ]

The investigators will measure the change of some index of B type ultrasonography ( the volume of uterus and ovary, the biggest follicle diameter )


Original Primary Outcome: Change in some index of B type ultrasonography ( uterus,ovary,follicle ) [ Time Frame: 3 months, 6months ]

We will measure the change of some index of B type ultrasonography ( the volume of uterus and ovary, the biggest follicle diameter )


Current Secondary Outcome:

  • change in the mammary nucleus index [ Time Frame: 3 months, 6 months ]
    The investigators will measure the change of the mammary nucleus index by the mammary diameter
  • change in the cumulative score of traditional Chinese medicine syndromes [ Time Frame: 3 months, 6 months ]
    The investigators will measure the change in scores of chinese medicine symptoms according to the Traditional Chinese Medicine Guideline Scale: 0 - 3. 0 = None. 1 = Mild. 2 = Moderate. 3= Severe


Original Secondary Outcome:

  • change in the mammary nucleus index [ Time Frame: 3 months, 6 months ]
    We will measure the change of the mammary nucleus index by the mammary diameter
  • change in the cumulative score of traditional Chinese medicine syndromes [ Time Frame: 3 months, 6 months ]
    We will measure the change in scores of chinese medicine symptoms according to the Traditional Chinese Medicine Guideline Scale: 0 - 3. 0 = None. 1 = Mild. 2 = Moderate. 3= Severe


Information By: Children's Hospital of Fudan University

Dates:
Date Received: January 4, 2016
Date Started: August 2013
Date Completion: April 2017
Last Updated: April 30, 2016
Last Verified: April 2016