Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tanshinone in Polycystic Ovary Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01452477
Recruitment Status : Unknown
Verified September 2013 by Xiaoke Wu, Heilongjiang University of Chinese Medicine.
Recruitment status was:  Recruiting
First Posted : October 14, 2011
Last Update Posted : September 4, 2013
Sponsor:
Information provided by (Responsible Party):
Xiaoke Wu, Heilongjiang University of Chinese Medicine

Tracking Information
First Submitted Date  ICMJE October 6, 2011
First Posted Date  ICMJE October 14, 2011
Last Update Posted Date September 4, 2013
Study Start Date  ICMJE October 2011
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2013)
basal testosterone [ Time Frame: 3 months ]
The primary outcome measure is a decrease in basal testosterone.
Original Primary Outcome Measures  ICMJE
 (submitted: October 12, 2011)
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。
Change History Complete list of historical versions of study NCT01452477 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2013)
  • 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 Measures  ICMJE
 (submitted: October 12, 2011)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tanshinone in Polycystic Ovary Syndrome
Official Title  ICMJE 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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Polycystic Ovary Syndrome
Intervention  ICMJE
  • Drug: tanshinone
    tanshinone 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks.
  • Drug: tanshinone placebo
    placebo 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks.
Study Arms  ICMJE
  • Active Comparator: tanshinone
    tanshinone 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks.
    Intervention: Drug: tanshinone
  • Placebo Comparator: tanshinone placebo
    placebo 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks.
    Intervention: Drug: tanshinone placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 20, 2011)
100
Original Estimated Enrollment  ICMJE
 (submitted: October 12, 2011)
40
Estimated Study Completion Date  ICMJE July 2014
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Presence of PCOS diagnosed based on the Androgen Excess Society criteria. All subjects must have hyperandrogenism (hirsutism and/or hyperandrogenemia), ovarian dysfunction (oligoanovulation and/or polycystic ovaries), and exclusion of other androgen excess related disorders. Oligomenorrhea is defined as an intermenstrual interval >35 days or <8 menstrual bleedings in the past year. Amenorrhea is defined as an intermenstrual interval >90 days. Clinical hyperandrogenism is defined as a Ferriman-Gallwey (FG) score ≥5
  • Age of women from 18 to 35 years;
  • No desire of children within 6 month and use condoms for contraception.

Exclusion Criteria:

  • Use of hormonal drugs or other medications, which can affect the results of the study especially Chinese herbal prescriptions in the past 12 weeks;
  • Patients with other androgen excess endocrine disorders including 21-hydroxylase deficiency, hyperprolactinemia, Cushing syndrome, severe insulin resistance, thyroid dysfunction;
  • Patients with history of sever cardiac , pulmonary, hepatic, renal, neurologic disease or mental illness;
  • Pregnancy or lactation.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 36 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01452477
Other Study ID Numbers  ICMJE Tanshinone-HLJUCM
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xiaoke Wu, Heilongjiang University of Chinese Medicine
Study Sponsor  ICMJE Heilongjiang University of Chinese Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Xiaoke Wu, docotor The First Affliated Hospital,Heilongjiang University of Chinese Medicine .
PRS Account Heilongjiang University of Chinese Medicine
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP