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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000005079
Receipt No. 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

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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
Obsterics 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
Email

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
Email khayashi@health.gunma-u.ac.jp

Sponsor
Institute Hirosaki University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006042

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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