UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003429 |
|---|---|
| Receipt number | R000004152 |
| Scientific Title | Efficacy and safety of Kamishoyosan in patients with climacteric symptom associated with depressive state |
| Date of disclosure of the study information | 2010/04/01 |
| Last modified on | 2010/04/01 18:09:45 |
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Basic information
Public title
Efficacy and safety of Kamishoyosan in patients with climacteric symptom associated with depressive state
Acronym
Efficacy and safety of Kamishoyosan in patients with climacteric symptom associated with depressive state
Scientific Title
Efficacy and safety of Kamishoyosan in patients with climacteric symptom associated with depressive state
Scientific Title:Acronym
Efficacy and safety of Kamishoyosan in patients with climacteric symptom associated with depressive state
Region
| Japan |
Condition
Condition
Climacteric symptom
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine differences in the efficacy of Kamishoyosan in comparison with paroxetine in patients with climacteric symptom associated with depressive state according to objectively validated indices, to explore the mechanism of action of Kamishoyosan based on clinical pharmacological evaluation, and to collect safety information of this Kampo medicine.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of time profile of anxiety state, depressive state, and symptoms of climacteric symptom with questionnaires (STAI, SDS, and Questionnaire for Assessment of Climacteric Symptoms)
Key secondary outcomes
Clinical pharmacological evaluation (changes in GABA and three fractions of catecholamine)
Drug safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Kamishoyosan
Usually, in adults, administer orally at 7.5 g/day in two to three divided doses before or between meals. Adjust the dose as needed according to the age, body weight and symptoms of patients.
Treatment duration: 56 days
Interventions/Control_2
Paroxetine
Usually, in adults, administer orally 20 to 40 mg as paroxetine once daily after dinner.
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
2)Females with at least 6 months after the last menstruation, or, if it is unknown due to hysterectomy when menopause occurs, females at 60 years or younger whose FSH was 40 mIU/ml or higher within the last 6 months
3)Patients with SDS raw scores between 40 points and less than 70 points
4)Inpatient/Outpatient status: Outpatient
5)Patients who gives written informed consent
Key exclusion criteria
1)Patients with Major Depressive Episode according to the DSM-IV diagnostic criteria
2)Patients with a history of psychiatric disease
3)Patients who have undergone oophorectomy within the last 6 months
4)Patients who have taken neurological drugs (antianxiety drugs, sedative hypnotics, antiepileptic drugs, analeptics/psychostimulants, antiparkinson drugs, psychoneurological drugs, autonomic drugs (benzodiazepines, and antidepressants), and/or Kampo medicine within 2 weeks before enrollment
5)Patients who have used estrogens and gestagens within 4 weeks before enrollment
6)Patients with serious complications (e.g., hepatic, renal, cardiac, pulmonary, hematological, or metabolic diseases)
7)Patients with a history of drug allergy
8)Patients who have been treated with any investigational drug or will participate in a clinical trial within 4 weeks before enrollment
9)Patients for whom paroxetine is contraindicated
10)Other patients who are assessed to be inappropriate for study participation by the investigator, or other relevant persons
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Mizunuma |
Organization
University hospital, Hirosaki University School of Medicine
Division name
Dept. Of Obstetrics & Gynecology
Zip code
Address
53 Hon-cho, Hisosaki, Aomori
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Higuchi |
Organization
University hospital, Hirosaki University School of Medicine
Division name
Dept. Of Obstetrics & Gynecology
Zip code
Address
53 Hon-cho, Hisosaki, Aomori
TEL
Homepage URL
Sponsor or person
Institute
University hospital, Hirosaki University School of Medicine Dept. of Obstetrics & Gynecology
Institute
Department
Personal name
Funding Source
Organization
TSUMURA & CO.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
弘前大学医学部附属病院（青森県）、青森市民病院（青森県）、小野レディスクリニック（青森県）、野辺地病院（青森県）、独立行政法人国立病院機構弘前病院（青森県）、弘前レディスクリニック（青森県）、婦人科さかもとともみクリニック（青森県）、大館市立総合病院（秋田県）、東京歯科大学市川総合病院（千葉県）、牧田産婦人科（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 02 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 04 | Month | 01 | Day |
Last modified on
| 2010 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004152
