Effect of Berberine on Hormonal and Metabolic Features in... | NCT01138930

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

NCT01138930

Sponsor

Heilongjiang University of Chinese Medicine

Status

Unknown status

Last Update Posted

May 10, 2013Estimated

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Polycystic Ovary Syndrome
Obesity

Interventions

Berberine
Placebo

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Jun 2013Estimated

Completion Date

Jun 2013Estimated

First Submitted Date

Jun 7, 2010

First Submission Date that Met QC Criteria

Jun 7, 2010

First Posted Date

Jun 8, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 8, 2013

Last Update Posted Date

May 10, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Berberine has showed effective in lowering blood sugar levels in db/db mice and anti-dyslipidemia in human.Studies on the effect of berberine on metabolic and hormonal features of women with polycystic ovary syndrome (PCOS) are lacking.The objective of this study is to examine the effect of Berberine metabolic and hormonal parameters and insulin resistance in obese patients with PCOS.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Label	Type	Description	Intervention Names
Berberine	Experimental		Drug: Berberine
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Berberine	Drug	1.5g daily for 3 month	Berberine
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Whole body insulin action	Glucose Disposal Rate measured by hyperinsulinemic euglycemic clamp	3 months

Secondary Outcomes

Measure	Description	Time Frame
Oral glucose tolerance test (OGTT)		3 months
Ovarian androgen biosynthesis		3 months
Hormonal profile

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Age of women between 18 and 35 years.
Confirmed diagnosis of PCOS according to the modified Rotterdam criteria and all subjects must have anovulation plus either polycystic ovaries and/or hyperandrogenism.
Body mass index (BMI) equal to or greater than 23 kg/m2.
With no desire of children within 6 month. PCOS is defined by the modified Rotterdam criteria: oligomenorrhea or amenorrhea, together with presence of ≥12 antral follicles (≤9mm) and/or ovarian volume >10 ml on transvaginal scanning, and/or clinical/biochemical hyperandrogenism. Oligomenorrhea is defined as an intermenstrual interval >35 days and <8 menstrual bleedings in the past year. Amenorrhea is defined as an intermenstrual interval >90 days. Clinical hyperandrogenism in China Mainland is defined as a Ferriman-Gallwey (FG) score ≥5.

Exclusion criteria are

Use of hormonal drugs or other medications including Chinese Herbal prescriptions in the past 3 months.
Patients with other endocrine disorders including 21-hydroxylase deficiency, hyperprolactinemia, uncorrected thyroid disease, suspected Cushing's syndrome
Patients with known sever organ dysfunction or mental illness.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiaoke Wu, MD.PhD.	Contact	86-451-8213 0094		xiaokewu2002@vip.sina.com
Lihui Hou, MD.	Contact	86-451-8213 0094		houlihui2007@sina.com

Overall Officials

Name	Affiliation	Role
Lihui Hou, MD.	The First Affliated Hospital,Heilongjiang University of Chinese Medicine .	Study Chair
Xiaoke Wu, MD.PhD.	The First Affliated Hospital,Heilongjiang University of Chinese Medicine	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Affiliated Hospital of Guangzhou Medical University	Recruiting	Guangzhou	Guangdong		China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27769284	Derived	Zhang Y, Sun J, Zhang YJ, Chai QY, Zhang K, Ma HL, Wu XK, Liu JP. The effect of berberine on insulin resistance in women with polycystic ovary syndrome: detailed statistical analysis plan (SAP) for a multicenter randomized controlled trial. Trials. 2016 Oct 21;17(1):512. doi: 10.1186/s13063-016-1633-5.
23866924	Derived

ID	Term
D010048	Ovarian Cysts
D003560	Cysts
D009369	Neoplasms
D010049	Ovarian Diseases
D000291

ID	Term
D001600	Berberine Alkaloids
D044182	Benzylisoquinolines
D000470	Alkaloids
D006571	Heterocyclic Compounds

ID	Term
D011085	Polycystic Ovary Syndrome
D009765	Obesity