UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026251 |
|---|---|
| Receipt number | R000030153 |
| Scientific Title | The effect of Lumbricus rubellus for tinnitus control: randomized double-blind placebo-controlled clinical trial |
| Date of disclosure of the study information | 2017/03/01 |
| Last modified on | 2019/02/06 13:54:35 |
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Basic information
Public title
The effect of Lumbricus rubellus for tinnitus control: randomized double-blind placebo-controlled clinical trial
Acronym
The effect of Lumbricus rubellus for tinnitus control
Scientific Title
The effect of Lumbricus rubellus for tinnitus control: randomized double-blind placebo-controlled clinical trial
Scientific Title:Acronym
The effect of Lumbricus rubellus for tinnitus control
Region
| Japan |
Condition
Condition
Bilateral tinnitus in patients with age-associated hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the effect of Lumbricus rebellus on control of bilateral tinnitus in patients with age-associated hearing loss
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tinnitus Handicap Inventory (THI-25), 4 weeks after medication
Key secondary outcomes
1) Pure Tone Audiometry, Speech Audiometry
2) Pitch match test
3) GTT test(coagulation time,lysis time)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Lumbricus rubellus 600mg per day, 4 weeks
Interventions/Control_2
placebo 4 weeks
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients show age-related hearing loss
2) Patients have bilateral tinnitus
Key exclusion criteria
1) Tinnitus derived from inner ear diseases (sudden hearing loss, acoustic tumor, acoustic trauma, otosclerosis)
2) unilateral tinnitus
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiji Matsuda |
Organization
University of Miyazaki
Division name
Department of Otorhinolaryngology, Head and Neck Surgery
Zip code
Address
5200 Kihara, Kiyotake, Miyazaki city
TEL
0985-85-2966
kmatsuda@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiji Matsuda |
Organization
University of Miyazaki
Division name
Department of Otorhinolaryngology, Head and Neck Surgery
Zip code
Address
5200 Kihara, Kiyotake, Miyazaki city
TEL
0985-85-2966
Homepage URL
kmatsuda@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
None
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
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
宮崎大学病院（宮崎県）
Other administrative information
Date of disclosure of the study information
| 2017 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 02 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 21 | Day |
Last modified on
| 2019 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030153
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
