UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013220 |
|---|---|
| Receipt number | R000015014 |
| Scientific Title | Effect of the iron-lactoferrin complex on women with primary dysmenorrhea |
| Date of disclosure of the study information | 2014/02/22 |
| Last modified on | 2014/02/22 07:39:37 |
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Basic information
Public title
Effect of the iron-lactoferrin complex on women with primary dysmenorrhea
Acronym
Effectiveness of the iron-lactoferrin complex on dysmenorrhea
Scientific Title
Effect of the iron-lactoferrin complex on women with primary dysmenorrhea
Scientific Title:Acronym
Effectiveness of the iron-lactoferrin complex on dysmenorrhea
Region
| Japan |
Condition
Condition
Primary dysmenorrhea
Classification by specialty
| Psychosomatic Internal Medicine | Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Primary dysmenorrhea is painful menstrual cramps without any evident pathology to account for them, and causes significant disruption in quality of life. Lactoferrin is a glycoprotein often occurred in mammalian grand such as cow's milk. Bovine lactoferrin shows analgestic effect via central nerve system in rodents and a few pilot studies in human. The aim of this trial is to investigate the effectiveness of the iron-lactoferrin complex on subjective symptoms associated with menstruation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome is a combination of subjective measurements (Moos menstrual distress questionnaire, Visual rating scale, and Verbal rating scale) and an objective measurement (Finger-tip accelerated plethysmography) during a menstruating period.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
In a crossover design, two tablets containing the iron-lactoferrin complex are orally administrated daily during the menstruating period, followed by the wash-out period until the next menstruating period. In the next menstruating period, two placebo tablets are administrated.
Interventions/Control_2
In a crossover design, two placebo tablets are orally administrated daily during the menstruating period, followed by the wash-out period until the next menstruating period. In the next menstruating period, two tablets containing the iron-lactoferrin complex are administrated.
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
Females from 20 years old to 49 years old having pain sensation during menstrual phase
Key exclusion criteria
1) Subject having medical treatment in a hospital or clinic
2) Subject having treatment or previous history for serious cardiovascular, respiratory, endocrine, or metabolic disorders
3) Subject having any infectious diseases or their possibility
4) Subject who ended participation in another clinical trial less than 3 months before
5) Subject having cedar or cypress pollen allergy
6) Subject having a food allergy, specially dairy products
7) For female subjects: pregnancy or possibility of pregnancy, or intending to become pregnant during the study.
8) Subject who has had a blood sample of 200 ml or more taken (e.g., donated blood) within 1 month, or 400 ml or more within 3 months of the start of the present study
9) Subject deemed unsuitable by the investigator
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osami Kajimoto |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Medical Science on Fatigue
Zip code
Address
1-4-3 Asahimachi, Abeno-ku, Osaka
TEL
06-6645-6171
kajimoto@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiro Sugino |
Organization
Soiken Inc.
Division name
R&D Division
Zip code
Address
Senri Life Science Center 13F, 1-4-2 Shinsenri-higashimachi, Toyonaka, Osaka
TEL
06-6871-8888
Homepage URL
sugino@soiken.com
Sponsor or person
Institute
Soiken Inc.
Institute
Department
Personal name
Funding Source
Organization
Megmilk Snow Brand 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
ふくだ内科クリニック（大阪府）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | Month | 22 | 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
| 2011 | Year | 10 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 14 | 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
| 2014 | Year | 02 | Month | 22 | Day |
Last modified on
| 2014 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015014
