NCT01452477

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2011

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 14, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

September 4, 2013

Status Verified

September 1, 2013

Enrollment Period

2.2 years

First QC Date

October 6, 2011

Last Update Submit

September 3, 2013

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic Ovary SyndromeCryptotanshinone

Outcome Measures

Primary Outcomes (1)

  • basal testosterone

    The primary outcome measure is a decrease in basal testosterone.

    3 months

Secondary Outcomes (8)

  • Ovarian androgen biosynthesis

    3 months

  • Whole body insulin action

    3 months

  • Oral glucose tolerance test (OGTT)

    3 months

  • Reproductive hormones

    3 months

  • Fasting gluco-lipid metabolic profiles

    3 months

  • +3 more secondary outcomes

Study Arms (2)

tanshinone

ACTIVE COMPARATOR

tanshinone 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks.

Drug: tanshinone

tanshinone placebo

PLACEBO COMPARATOR

placebo 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks.

Drug: tanshinone placebo

Interventions

tanshinoneDRUG

tanshinone 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks.

tanshinone
tanshinone placeboDRUG

placebo 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks.

tanshinone placebo

Eligibility Criteria

Age18 Years - 36 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age of women from 18 to 35 years；
  • No desire of children within 6 month and use condoms for contraception.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Heilongjiang University of Chinese Medicine

Harbin, Heilongjiang, 150040, China

RECRUITING

Huaian Maternal and Child Health Hospital

Huaian, Jiangsu, 223001, China

RECRUITING

Lianyungang Maternal and Child Health Hospital

Lianyungang, Jiangsu, 222000, China

ACTIVE NOT RECRUITING

JiangXi University of Traditional Chinese Medicine

Nanchang, Jiangxi, 330000, China

COMPLETED

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

tanshinone

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Xiaoke Wu, docotor

    The First Affliated Hospital,Heilongjiang University of Chinese Medicine .

    STUDY CHAIR

Central Study Contacts

Xiaoke Wu, MD.PhD.

CONTACT

13796025599xiaokewu2002@vip.sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chairman Dept Obs & Gyn, First Affiliated Hospital

Study Record Dates

First Submitted

October 6, 2011

First Posted

October 14, 2011

Study Start

October 1, 2011

Primary Completion

December 1, 2013

Study Completion

July 1, 2014

Last Updated

September 4, 2013

Record last verified: 2013-09

Locations

CN(4)