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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026251
Receipt No. 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

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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
Email 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
Email kmatsuda@med.miyazaki-u.ac.jp

Sponsor
Institute University of Miyazaki
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030153

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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