UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028857 |
|---|---|
| Receipt number | R000032928 |
| Scientific Title | A study of the synergy effects of BRM-A, the principal component of EF2001 lactic acid bacterium, and Byakkokaninjinto, for atopic dermatitis. |
| Date of disclosure of the study information | 2017/08/31 |
| Last modified on | 2019/03/31 17:10:22 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study of the synergy effects of BRM-A, the principal component of EF2001 lactic acid bacterium, and Byakkokaninjinto, for atopic dermatitis.
Acronym
A study of the synergy effects of lactic acid bacterium dietary supplement with Byakkokaninjinto for atopic dermatitis.
Scientific Title
A study of the synergy effects of BRM-A, the principal component of EF2001 lactic acid bacterium, and Byakkokaninjinto, for atopic dermatitis.
Scientific Title:Acronym
A study of the synergy effects of lactic acid bacterium dietary supplement with Byakkokaninjinto for atopic dermatitis.
Region
| Japan |
Condition
Condition
atopic dermatitis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparative evaluation of EF2001 Lactobacillus-based BRM-A and Byakkokaninjinto, and their synergy effects for atopic dermatitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Thymus and activationregulated chemokine (TARC)
Key secondary outcomes
Eosinophil count
Immunoglobulin E (IgE)
Lactate dehydrogenase (LDH)
C-reactive protein (CRP)
Leukocytes count
Gamma-Glutamyl Transferase (Gamma-GT)
Aspartate Aminotransferase (AST)
Alanine Aminotransferase (ALT)
Active-oxygen scavenging activity
Visual Analog Scale (VAS)
SCORing Atopic Dermatitis (SCORAD)
Concomitant drug
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine | Food |
Interventions/Control_1
BRM-A
Dosage regimen: 2 times a day. Takes 1 pack(1000mg) per each dose. To be taken between meals.
Administration period: 3 months
Interventions/Control_2
Byakkokaninjinto extract fine granule
Dosage regimen: 3 times a day. Takes 1 pack(4000mg) per each dose.To be taken between meals.
Administration period: 3 months
Interventions/Control_3
BRM-A and Byakkokaninjinto extract fine granule combined
Dosage regimen: To be taken between meals.
(BRM-A) 2 times a day. Takes 1 pack(1000mg) per each dose.
(Byakkokaninjinto) 3 times a day. Takes 1 pack(4000mg) per each dose.
Administration period: 3 months
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients with atopic dermatitis
2.Patients who agree to participate in this study with a written informed consent.
Key exclusion criteria
1.Patients with serious underlying disease.
2.Patients currently taking lactic acid bacterium or any Kampo medicine.
3.Patients with adverse reactions to blood sampling.
4.Pregnant Patients.
5.Patients deemed inappropriate for the study by the blood-collecting Doctor.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Iwai |
Organization
School of Pharmacy, Showa University
Division name
Department of Healthcare and Regulatory Science
Zip code
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8215
s-iwai@pharm.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Nishijima |
Organization
School of Pharmacy, Showa University
Division name
Department of Healthcare and Regulatory Science
Zip code
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8215
Homepage URL
heiwado@nr.catv.ne.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
Yokohama University of Pharmacy
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Maruyama Allergy Clinic
Name of secondary funder(s)
Heiwado Pharmacy
NIHON BERUMU CO.,LTD.
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 31 | 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
| 2017 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 28 | Day |
Last modified on
| 2019 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032928
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
