UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035480 |
|---|---|
| Receipt number | 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 | 2024/05/17 17:18:09 |
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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
Name of lead principal investigator
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Nakamura |
Organization
Higashi Koganei Sakura Clinic
Division name
Chairman
Zip code
184-0011
Address
4-37-26,Higashicho,Koganei-shi,Tokyo,Japan
TEL
042-382-3081
clinical-trial@imeqrd.co.jp
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co., Ltd
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd
Institute
Department
Personal name
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
Suda Clinic institutional review board
Address
2-8-14, Takadanobaba, Shinjyuku, Tokyo, Japan
Tel
03-6704-5968
jimukyoku@imeqrd.co.jp
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
81
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
| 2018 | Year | 11 | Month | 13 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 16 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
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
| 2024 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040428
