Study the Effect of Danggui Buxue Tang on Menopausal Symp... | NCT00421564

Studies
Study the Effect of Danggui Buxue Tang on Menopausal Symptoms

NCT00421564

Sponsor

Chinese University of Hong Kong

Status

Completed

Last Update Posted

Jan 12, 2007Estimated

Enrollment

100

Phase

Phase 2

Conditions

Menopause

Interventions

DBT-Danggui Buxue Tang

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

Jan 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2003

Primary Completion Date

Not provided

Completion Date

Dec 2004

First Submitted Date

Jan 11, 2007

First Submission Date that Met QC Criteria

Jan 11, 2007

First Posted Date

Jan 12, 2007Estimated

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

Jan 11, 2007

Last Update Posted Date

Jan 12, 2007Estimated

Description Module

Brief Summary

This study is to examine the effect and safety of the study drug,Danggui Buxue Tang, on menopausal symptoms of hot flushes and sweating and to determine whether the patient's quality of life will be improved.

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100

Name	Type	Description	Arm Group Labels	Other Names
DBT-Danggui Buxue Tang	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Changes in severity and frequency of hot flushes and sweats.

Secondary Outcomes

Measure	Description	Time Frame
The Changes in score of the Menopause Specific Quality of Life and the values of various markers of risk for cardiovascular disease.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Follicle stimulating hormone (FSH), luteinizing hormone (LH), oestradiol in the menopausal range (FSH>18 IU/L, LH>12.6 IU/L, and E2< 361 pmol/l).
Patients with amenorrhoea for more than 12 months

Exclusion Criteria:

Patients with a history of using any form of hormonal replacement therapy within 8 weeks
Patients with a history of using Chinese medicine or other therapies which may affect the outcome within 8 weeks
Patients who in the judgment of the investigator will be unable to comply with protocol requirements
Patients with significant** gastrointestinal, renal, hepatic, bronchopulmonary, neurological, cardiovascular, breast or endometrial carcinoma, or allergic diseases
Patients with uncontrolled hypertension
Patients with undiagnosed vaginal bleeding
Patients with a history of significant drug hypersensitivity

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christopher J Haines, FPOGS	Department of Obstetrics & Gynaecology, CUHK	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Obstetrics & Gynaecology, CUHK, Prince of Wales Hospital		Hong Kong			China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
3468732	Background	Hagstad A, Janson PO. The epidemiology of climacteric symptoms. Acta Obstet Gynecol Scand Suppl. 1986;134:59-65. doi: 10.3109/00016348609157052.
10661612	Background	Schneider HP, Gallagher JC. Moderation of the daily dose of HRT: benefits for patients. Maturitas. 1999 Nov;33 Suppl 1:S25-9. doi: 10.1016/s0378-5122(99)00060-2.