Clinical Trial: Tanshinone in Polycystic Ovary Syndrome

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Effect of Tanshinone on Hormonal and Metabolic Features in Women With Polycystic Ovary Syndrome (PCOS)

Brief Summary: Tanshinone was originally isolated from dried roots of Salvia miltiorrhiza bunge. In Chinese medicine, this herb has been widely prescribed for several pathologies, including diabetes, acne, cardiovascular disease.It has been demonstrated that the therapeutic benefit of cryptotanshinone on prenatally androgenized rats may be mediated by its dual regulation of key molecules during both insulin signaling and androgen synthesis.The purpose of this study is to determine whether tanshinone may prove effective in eradicating Polycystic Ovary Syndrome (PCOS) symptomatology.

Detailed Summary:
Sponsor: Heilongjiang University of Chinese Medicine

Current Primary Outcome: basal testosterone [ Time Frame: 3 months ]

The primary outcome measure is a decrease in basal testosterone.


Original Primary Outcome: Ovarian androgen biosynthesis [ Time Frame: Up to 1 year ]

Ovarian androgen biosynthesis as measured by HCG-stimulated production of 17- hydroxyprogesterone (17OHP)，T，A2，DHEAS。


Current Secondary Outcome:

  • Ovarian androgen biosynthesis [ Time Frame: 3 months ]
    Human chorionic gonadotropin (HCG) induced response of androgens including 17-hydroxyprogesterone (17-OHP), androstenedione (A2), testosterone (T)
  • Whole body insulin action [ Time Frame: 3 months ]
    Insulin resistance by the glucose disposal rate (GDR) with hyperinsulinemic euglycemic clamp test
  • Oral glucose tolerance test (OGTT) [ Time Frame: 3 months ]
    All the participants will undergo an overnight fast. After ingestion of a 75-g glucose load, blood samples will be obtained at 0, 30, 60, 90, and 120min for glucose and insulin level determination.
  • Reproductive hormones [ Time Frame: 3 months ]
    estradiol (E2), 17-α-hydroxyprogesterone (17-OHP), follicle stimulation hormone (FSH), leutinizing hormone (LH), sex hormone binding globulin and dehydroepiandrosterone sulphate.
  • Fasting gluco-lipid metabolic profiles [ Time Frame: 3 months ]
  • quality of life [ Time Frame: 3 months ]
    the quality of life will be assessed by the Polycystic Ovary Syndrome Questionnaire (PCOS-QOL)and the Chinese Quality of Life (ChQOL).
  • Weight, waist/hip circumference, blood pressure, F-G score and acne before and after treatment [ Time Frame: 3 months ]
  • Adverse events [ Time Frame: 3 months ]


Original Secondary Outcome:

  • Insulin action [ Time Frame: Up to 1 year ]
    Insulin action including fasting serum insulin level,C-Peptide
  • Reproductive/Hormonal Measures [ Time Frame: Up to 1 year ]
    Fasting FSH,LH,T,SHBG,A2,DHEAS
  • Glucose metabolism [ Time Frame: Up to 1 year ]
    OGTT tests before and after treatment


Information By: Heilongjiang University of Chinese Medicine

Dates:
Date Received: October 6, 2011
Date Started: October 2011
Date Completion: July 2014
Last Updated: September 3, 2013
Last Verified: September 2013