UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005079 |
|---|---|
| Receipt number | R000006042 |
| Scientific Title | A randomized double blind, placebo-controlled trial of efficacy and safety of Kamishoyosan in patients with climacteric symptoms |
| Date of disclosure of the study information | 2011/03/01 |
| Last modified on | 2013/02/25 17:40:48 |
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Basic information
Public title
A randomized double blind, placebo-controlled trial of efficacy and safety of Kamishoyosan in patients with climacteric symptoms
Acronym
A randomized double blind, placebo-controlled trial of efficacy and safety of Kamishoyosan in patients with climacteric symptoms
Scientific Title
A randomized double blind, placebo-controlled trial of efficacy and safety of Kamishoyosan in patients with climacteric symptoms
Scientific Title:Acronym
A randomized double blind, placebo-controlled trial of efficacy and safety of Kamishoyosan in patients with climacteric symptoms
Region
| Japan |
Condition
Condition
Climacteric symptoms
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main objective is to scientifically examine the efficacy of Kamishoyosan in patients with climacteric symptoms.
The secondary objective is to clarify the profile of symptoms for which Kamishoyosan effectively works.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Drug efficacy
Evaluation of chronological changes with questionnaires
*Self-rating depression Scale, SDS
*Severity and frequency of hot flash
*State-Trait Anxiety Inventory, STAI
*SF-36
*Questionnaire for assessment of climacteric symptoms in Japanese women
Key secondary outcomes
Drug Safety
*Adverse events, Side effects
*Biochemical examination
*Hormonal examination (serum FSH, TSH)
*Weight, Blood pressure
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Kamishoyosan
7.5 g/day in three divided doses before or between meals.
Treatment duration: 56 days
Interventions/Control_2
Placebo
(A pharmacologically inactive substance made of lactose which looks, tastes and smells identical to Kanishoyosan)
7.5 g/day in three divided doses before or between meals.
Treatment duration: 56 days
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
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Patients who are diagnosed with climacteric symptom (not mentioned about menopause)
2) Patients who give written informed consent
3) Patients with SDS raw scores less than 60 points.
4) Patients who have not been treated with hormone replacement therapy, Kampo medicine therapy and/or prohibited concomitant drugs (sex steroid hormone, antianxiety drugs, antidepressant drug, SSRI, SNRI, autonomic drugs, Kallidinogenase, hypnotic drug) within 4 weeks before enrollment
Key exclusion criteria
1) Patients with serious gastrointestinal weakness
2) Patients with anorexia, nausea and/or vomiting
3) Patients with psycho-neurologic disease (SDS>=60)
4) Patients with a history of drug allergy or hypersensitivity reaction to Kampo medicine
5) Patients with serious complications (hepatic, renal, cardiac diseases or malignancy tumor)
6) Patients who have been participated in other clinical trial within 4months before enrollment, or will participate in a clinical trial.
7) Patients who are assessed to be inappropriate for study participation by the investigator.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Mizunuma |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
5 Zaifu, Hirosaki, Aomori 036-8562, Japan
TEL
0172-33-5107
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kunihiko Hayashi |
Organization
Gunma University
Division name
School of Health Science
Zip code
Address
3-39-15 Showa-machi, Maebashi, Gunma
TEL
027-220-8974
Homepage URL
khayashi@health.gunma-u.ac.jp
Sponsor or person
Institute
Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Research Grant of the Japan Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Keio University
Hokkaido University
Tokyo Dental College Ichikawa
The University of Tokushima
Tokyo Medical and Dental University
TSUMURA & CO. TSUMURA research
laboratories
Tohoku University
Gunma University
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
北海道、青森県、宮城県、千葉県、東京都、徳島県
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 02 | Month | 25 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 14 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 20 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 14 | Day |
Last modified on
| 2013 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006042
| Research Plan | |
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| Registered date | File name |
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