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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035480
Receipt No. R000040428
Scientific Title Validating the effects of long-term intake of Dr's Lumbricus supplement on serum uric acid levels.
Date of disclosure of the study information 2019/01/11
Last modified on 2019/01/08

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Basic information
Public title Validating the effects of long-term intake of Dr's Lumbricus supplement on serum uric acid levels.
Acronym Validating the effects of long-term intake of Dr's Lumbricus supplement on serum uric acid levels.
Scientific Title Validating the effects of long-term intake of Dr's Lumbricus supplement on serum uric acid levels.
Scientific Title:Acronym Validating the effects of long-term intake of Dr's Lumbricus supplement on serum uric acid levels.
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine QOL improvement after healthy men with slightly higher levels of uric acid take supplements for 12 weeks to reduce uric acid.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Serum uric acid
Key secondary outcomes SF-8(QOL questionnaire)

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 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Take 4 tablets of Dr's Lumbricus supplement s.i.d. before meals.
Interventions/Control_2 Take 4 tablets (2 for Dr's Lumbricus supplement and 2 for placebo) s.i.d. before meals.
Interventions/Control_3 Take 4 tablets of placebo s.i.d. before meals.
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
65 years-old >
Gender Male
Key inclusion criteria 1. 20 to 64 years old (at the time of submission of an informed consent document)
2. Healthy adults (who were judged as healthy individuals by the principal investigator)
3. Men
4. Body mass index (BMI) of less than 30 kg/m2
5. Non-smokers
6. Uric acid levels of 6.0-7.0mg/dl
7. Those who can take supplements for 3 months
8.Those who can provide their written informed consent.
Key exclusion criteria 1. Those who currently need to take medications (except for drugs that are taken as needed) or who need to visit a doctor regularly.
2. Those with one of the following: gouty arthritis, gouty node, and a past medical history of gout attack.
3. Those who have participated in another clinical trial within a month prior to submission of an informed consent document for this trial.
4. Those with a past and current medical history of drug or food allergy.
5. Those who currently take health food (such as food products to maintain or restore health and supplements).
6. Those who were determined by the principal investigator to be unsuitable for participation in this clinical trial.
Target sample size 81

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Kiyoshi Nakamura
Organization Higashi Koganei Sakura Clinic
Division name Chairman
Zip code
Address 4-37-26,Higashicho,Koganei-shi,Tokyo,Japan
TEL 042-382-3081
Email higashikoganeisakura-clinic@imeq.co.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Naomi Yuzawa
Organization imeQ RD inc.
Division name Sales department
Zip code
Address 2-14-6, Nishi-Waseda, Shinjyuku, Tokyo, Japan
TEL 03-6205-6222
Homepage URL
Email n-yuzawa@imeqrd.co.jp

Sponsor
Institute imeQ RD inc.
Institute
Department

Funding Source
Organization Joyful Life Inc.
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

Other administrative information
Date of disclosure of the study information
2019 Year 01 Month 11 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 Preinitiation
Date of protocol fixation
2018 Year 11 Month 13 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 16 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
2019 Year 01 Month 08 Day
Last modified on
2019 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040428

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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