UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033112 |
|---|---|
| Receipt number | R000037760 |
| Scientific Title | A verification study for improving unidentified complaints with the test food containing Korean ginseng in healthy subjects: a randomized, single-blind, placebo-controlled, parallel-group trial |
| Date of disclosure of the study information | 2018/06/22 |
| Last modified on | 2019/06/17 13:52:21 |
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Basic information
Public title
A verification study for improving unidentified complaints with the test food containing Korean ginseng in healthy subjects: a randomized, single-blind, placebo-controlled, parallel-group trial
Acronym
A verification study for improving unidentified complaints with the test food in humans
Scientific Title
A verification study for improving unidentified complaints with the test food containing Korean ginseng in healthy subjects: a randomized, single-blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym
A verification study for improving unidentified complaints with the test food in humans
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the unidentified complaints improvement with the test food containing Korean ginseng for 12 weeks in healthy Japanese adult subjects with experiencing unidentified complaints
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
A questionnaire about unidentified complaints
* Each item is assessed with a seven-point grading scale and the smaller number indicates more severe subjective symptoms. Furthermore, compared the results of the questionnaire at screening (before consumption) and at 4, 8, and 12 weeks after consumption, the grading scale is increased by 3 points and more indicating complete response, by 2 points indicating improvement, by 1 points indicating slight improvement, and by 0 points indicating maintaining health while the grading scale is decreased by 1 point and more indicating worsening.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test material: Capsule containing Korean ginseng
Dose: Take 2 capsules containing Korean ginseng per day
Administration: Take 2 capsules with water or warm water at any time during the day
* If you forget to take the capsules, take capsules as soon as you remember within the day.
Interventions/Control_2
Duration: 12 weeks
Test material: Capsule containing Korean ginseng and placebo
Dose: Take a total of 2 capsules per day (1 capsule for each test food)
Administration: Take a total of 2 capsules (one capsule for containing Korean ginseng and another capsule for placebo capsule) with water or warm water at any time during the day
* If you forget to take the capsules, take capsules as soon as you remember within the day.
Interventions/Control_3
Duration: 12 weeks
Test material: Placebo
Dose: Take 2 placebo capsules per day
Administration: Take 2 capsules with water or warm water at any time during the day
* If you forget to take the capsules, take capsules as soon as you remember within the day.
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. Healthy Japanese adult subjects with experiencing unidentified complaints such as being tired, inability to sleep, stiff shoulders, constipation, cold hands and feet, and others
2. Subjects who are considered as appropriate for the study by the physician based on the results of peripheral blood test (endocrine test)
3. Subjects who are considered as appropriate for the study by the physician based on the score on the Beck Depression Inventory
4. Within the subjects who met the 2nd and 3rd inclusion criteria, subjects who get 3-4 points in all of the 5 items, which are fatigue, sleeplessness, stiff shoulders, bowel movement, and cold hands and feet, on the questionnaire about unidentified complaints at screening (before consumption).
5. When subjects below the sample size, subjects who get 1-4 points in all of the 5 items are selected. In the case, we priority select subjects who obtained 1 point in relatively few items.
Key exclusion criteria
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, myocardial infarction, endometriosis, uterine myoma, and mental disorders
2. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver failure, kidney failure, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
3. Subjects who are undergoing medical treatment for erectile dysfunction (ED), prostatic hyperplasia, or a thyroid disorder
4. Subjects who have been diagnosed with a menopausal disorder and no treatment
5. Subjects who are on medication for any other diseases
6. Subjects who have suppurative inflammation (except for small cuts and scratches)
7. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily
8. Subjects who currently take sleeping pills or sleep-inducing drugs
9. Subjects who currently take painkillers such as loxoprofen (Loxonin) and others
10. Subjects who currently take other medications (including herbal medicines) and supplements
11. Subjects who are allergic to medicines and/or the test food related products
12. Subjects who are pregnant, breast-feeding, or planning to become pregnant
13. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial
14. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | YAMAMOTO |
Organization
ORTHOMEDICO Inc.
Division name
CEO
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
kazu@orthomedico.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | SUZUKI |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
KIM's Korean Ginseng Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel
03-5793-3623
info@takara-clinic.com
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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 22 | 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
48
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 | 06 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 22 | Day |
Last modified on
| 2019 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037760
