UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008387 |
|---|---|
| Receipt number | R000009862 |
| Scientific Title | Research on the comparison of effect between hormone replacement therapy and keishibukuryogan for patients with climacteric syndrome and relation with the estrogen receptor in the effect |
| Date of disclosure of the study information | 2012/07/09 |
| Last modified on | 2012/07/09 16:37:15 |
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Basic information
Public title
Research on the comparison of effect between hormone replacement therapy and keishibukuryogan for patients with climacteric syndrome and relation with the estrogen receptor in the effect
Acronym
The effects of hormone replacement therapy and Keishibukuryogan for climacteric syndrome according to
relation to estrogen receptor
Scientific Title
Research on the comparison of effect between hormone replacement therapy and keishibukuryogan for patients with climacteric syndrome and relation with the estrogen receptor in the effect
Scientific Title:Acronym
The effects of hormone replacement therapy and Keishibukuryogan for climacteric syndrome according to
relation to estrogen receptor
Region
| Japan |
Condition
Condition
climacteric syndrome
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The purpose is establishing the evidence of Kampo medicine treatment in climacteric syndrome by gene polymorphism analysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of Kupperman menopausal index
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Keishibukuryogan
Interventions/Control_2
Hormone replacement therapy
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
1) Positive in Kupperman index
2) Menses was delayed more than one month within the past year, or shorter than 25 days.
3) Hormone value: FSH is equal or more than 20 mIU / ml or anti-mullerian hormone is abnormal value.
Key exclusion criteria
1. Patients in the history of surgery of the ovaries or uterus
2. Patients with hypothyroidism and hyperthyroidism
3. Patients taking drugs of vasodilator
4. Patients with prohibition of estrogen (estrogen-dependent tumor, breast cancer, pregnant woman, serious liver damage, suspicious thrombosis and genital bleeding)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takao Namiki |
Organization
Graduate School of Medicine, Chiba University
Division name
Dept. of Japanese-Oriental(Kampo) Medcine,
Zip code
Address
1-8-1 Inohana Chuo-ku Chiba
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Graduate School of Medicine, Chiba University
Division name
Dept. of Japanese-Oriental(Kampo) Medcine,
Zip code
Address
TEL
Homepage URL
tnamiki@faculty.chiba-u.jp
Sponsor or person
Institute
Takao Namiki
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
UMIN000000186
Org. issuing International ID_1
UMIN
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 02 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 09 | Day |
Last modified on
| 2012 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009862
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
