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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033112
Receipt No. 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

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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
Email 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
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037760

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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