Tanshinone in Polycystic Ovary Syndrome

September 3, 2013 updated by: Xiaoke Wu, Heilongjiang University of Chinese Medicine

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150040
        • Recruiting
        • Heilongjiang University of Chinese Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wenjuan Shen, doctor
    • Jiangsu
      • Huaian, Jiangsu, China, 223001
        • Recruiting
        • Huaian Maternal and Child Health Hospital
        • Contact:
        • Principal Investigator:
          • Huiying Xue, bachlor
      • Lianyungang, Jiangsu, China, 222000
        • Active, not recruiting
        • Lianyungang Maternal and Child Health Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China, 330000
        • Completed
        • Jiangxi University of Traditional Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: tanshinone
tanshinone 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks.
Drug: tanshinone
tanshinone 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks.
Placebo Comparator: tanshinone placebo
placebo 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
basal testosterone
Time Frame: 3 months
The primary outcome measure is a decrease in basal testosterone.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 3 months
3 months
Ovarian androgen biosynthesis
Time Frame: 3 months
Human chorionic gonadotropin (HCG) induced response of androgens including 17-hydroxyprogesterone (17-OHP), androstenedione (A2), testosterone (T)
3 months
Whole body insulin action
Time Frame: 3 months
Insulin resistance by the glucose disposal rate (GDR) with hyperinsulinemic euglycemic clamp test
3 months
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.
3 months
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.
3 months
Fasting gluco-lipid metabolic profiles
Time Frame: 3 months
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).
3 months
Weight, waist/hip circumference, blood pressure, F-G score and acne before and after treatment
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heilongjiang University of Chinese Medicine

Investigators

  • Study Chair: Xiaoke Wu, docotor, The First Affliated Hospital,Heilongjiang University of Chinese Medicine .

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

July 1, 2014

Study Registration Dates

First Submitted

October 6, 2011

First Submitted That Met QC Criteria

October 12, 2011

First Posted (Estimate)

October 14, 2011

Study Record Updates

Last Update Posted (Estimate)

September 4, 2013

Last Update Submitted That Met QC Criteria

September 3, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tanshinone-HLJUCM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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