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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027297
Receipt No. R000031277
Scientific Title The safety assessment of the use model of prescribing Kampo medicine to use frequently for the dysmenorrhea
Date of disclosure of the study information 2017/05/10
Last modified on 2017/05/10

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Basic information
Public title The safety assessment of the use model of prescribing Kampo medicine to use frequently for the dysmenorrhea
Acronym The safety assessment of the use model of prescribing Kampo medicine to use frequently for the dysmenorrhea
Scientific Title The safety assessment of the use model of prescribing Kampo medicine to use frequently for the dysmenorrhea
Scientific Title:Acronym The safety assessment of the use model of prescribing Kampo medicine to use frequently for the dysmenorrhea
Region
Japan

Condition
Condition dysmenorrhea
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Confirm safety when clinical doctors used a statistical model by a forward clinical trial.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Effect to the menstrual colic of the patient in two months after Kampo medicine internal use
Key secondary outcomes Frequency of the adverse event

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 administration period is two months
dose: 2.5g/time , 7.5g/day
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
20 years-old <=
Age-upper limit
50 years-old >
Gender Female
Key inclusion criteria The person who consults the obstetrics and gynecology department outpatient of Keio University Hospital and the associated facilities
The person who is aware of menstrual pain
The person whom a doctor gave a diagnosis of dysmenorrhea
A menstrual cycle is the following for 38 days more than 25 days
The person who gets an agreement of the participation in examination in a document
Key exclusion criteria The person having a gynecologic disorder to need emergency
The person who enforces hormone treatment
The patient who has the serious disease and unstable organ disorders such as the malignant tumors except the gynecologic disorder
The person with a history of the internal use of the Kampo medicine preparation within the past two months
The person who has an allergy to Kampo medicine
The person with a remarkable digestive organ symptom
The person who participated in a clinical trial since a study start within the past three months
The person who judged that the chief physician was inappropriate
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaru Mimura
Organization Keio University School of medicine
Division name Center for Kampo Medicine
Zip code
Address SHINANOMACHI 35, SHINJYUKU-KU, TOKYO JAPAN 160-8582
TEL 03-5366-3824
Email mimura@a7.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuko Horiba
Organization Keio University School of medicine
Division name Center for Kampo Medicine
Zip code
Address SHINANOMACHI 35, SHINJYUKU-KU, TOKYO JAPAN 160-8582
TEL 03-5366-3824
Homepage URL
Email mannta217@keio.jp

Sponsor
Institute Keio University School
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2017 Year 05 Month 10 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 Preinitiation
Date of protocol fixation
2017 Year 03 Month 24 Day
Date of IRB
Anticipated trial start date
2017 Year 12 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
2017 Year 05 Month 10 Day
Last modified on
2017 Year 05 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031277

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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