UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025729 |
|---|---|
| Receipt number | R000029606 |
| Scientific Title | Effect of a herbal drug "Kyushin capsule F" on indefinite complains in women experiencing typical symptom of menopause |
| Date of disclosure of the study information | 2017/03/17 |
| Last modified on | 2017/05/10 17:49:13 |
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Basic information
Public title
Effect of a herbal drug "Kyushin capsule F" on indefinite complains in women experiencing typical symptom of menopause
Acronym
Effect of "Kyushin capsule F" on indefinite complains
Scientific Title
Effect of a herbal drug "Kyushin capsule F" on indefinite complains in women experiencing typical symptom of menopause
Scientific Title:Acronym
Effect of "Kyushin capsule F" on indefinite complains
Region
| Japan |
Condition
Condition
indefinite complains
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
confirm effectiveness of "Kyushin capsule F" on indefinite complains of women experiencing typical symptom of menopause
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
improvement factor of indefinite complains (on 2 weeks and 4 weeks after first administration)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
one capsule 3 times a day for 4 weeks
Interventions/Control_2
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Simplified menopause score has over 26
Key exclusion criteria
under treatment by other medicine
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiichi Sudoh |
Organization
Kyushin Pharmaceutical Co., Ltd.
Division name
Research and development
Zip code
Address
1-22-10 Wada Suginami-ku Tokyo
TEL
03-5385-3211
sudo@kyushin.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuharu Shimizu |
Organization
Kyushin Pharmaceutical Co., Ltd.
Division name
Research and development
Zip code
Address
1-22-10 Wada Suginami-ku Tokyo
TEL
03-5385-3211
Homepage URL
y-shimizu@kyushin.co.jp
Sponsor or person
Institute
CPCC Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kyushin Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit 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
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
チヨダパラメディカルケアクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2017 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2017 | Year | 02 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 18 | Day |
Last modified on
| 2017 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029606
