China Cimicifuga Trial of Climacteric Complaint Control | NCT00622986

Studies
China Cimicifuga Trial of Climacteric Complaint Control

NCT00622986

Sponsor

Shandong Luye Pharmaceutical Co., Ltd.

Status

Unknown status

Last Update Posted

Feb 25, 2008Estimated

Enrollment

288Estimated

Phase

Phase 4

Conditions

Climacteric Symptoms

Interventions

an extract of Cimicifuga Foetida L.
an extract of Cimicifuga Foetida L.
placebo
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

Feb 2008

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

Feb 2008

Primary Completion Date

Feb 2009Estimated

Completion Date

Feb 2009Estimated

First Submitted Date

Feb 14, 2008

First Submission Date that Met QC Criteria

Feb 22, 2008

First Posted Date

Feb 25, 2008Estimated

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

Feb 22, 2008

Last Update Posted Date

Feb 25, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

This study is designed to determine whether an extract of Cimicifuga Foetida L. is safe and efficacious to relieve the climacteric symptoms of Chinese women

Detailed Description

Extracts of Cimicifuga Racemosa (black cohosh) have been widely used in North America and Europe for decades for the treatment of menopause related problems, either as nutritional supplements or as pharmaceutical products. Previous clinical trials had shown that an extract of Cimicifuga Foetida L.(Ximingting, Luyepharm), which was standardized to have similar components of an extract of Cimicifuga Racemosa, was safe and efficacious to relieve the climacteric symptoms and signs in Chinese women who were recruited according to criteria categorized by theory of Traditional Chinese Medicine.We are interested to know whether it may have the same efficacy and safety profiles when judged with method and standard commonly accepted in western medicine.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

288Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A1	Experimental	perimenopausal women	Drug: an extract of Cimicifuga Foetida L.
A2	Placebo Comparator	perimenopausal women	Drug: placebo
B1	Experimental	early staged postmenopausal women	Drug: an extract of Cimicifuga Foetida L.
B2	Placebo Comparator	early staged postmenopausal women	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
an extract of Cimicifuga Foetida L.	Drug	Each patient will be given the medication of extract of Cimicifuga Foetida L. 2 tablets each day for 3 months.	B1

Measure	Description	Time Frame
Change of scores of Kupperman Index before and after the treatment		3 months

Measure	Description	Time Frame
Change of scores of Menopause Rating Scale before and after the treatment		3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Having climacteric symptoms with hot flushes >= 3 time per day
Score of Kupperman Index at baseline >= 20
In addition to these criteria, women who had menopause longer than 2 months but less than 12 months, with FSH > 15U/L were enrolled into the perimenopausal group. Women having menopause longer than 12 months but less than 5 years, with FSH >= 40U/L and E2 <= 30pg/ml, were assigned into early staged postmenopausal group.

Exclusion Criteria:

Having history of hysterectomy
Having HRT within 6 weeks
Having other drugs or nutritional supplements of relieving climacteric symptoms within one week
Having psychological counseling within one week
Having medical history of estrogen-dependent tumors
The result of pap smear exam at stage III and above
Having an uterine leiomyoma lager than 4 cm
The endometrial thickness lager than 0.5 cm
Having abnormal cardiac, liver or kidney functions
Having abnormal thyroid function
Having hypertension, diabetes and coronary heart diseases that were not under control
Pregnant or suspected pregnant woman
Having severe mental disorders that inhibit to understand the research purpose
Other conditions the investigators believed not suitable for enrollment

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shouqing Lin, MD	Contact	86-10-88068846		shouqing_lin2003@yahoo.com.cn

Overall Officials

Name	Affiliation	Role
Shouqing Lin, MD	Beijing Union Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fujian Provincal Maternal and Children Health Hospital	Recruiting	Fuzhou	Fujian	350001	China