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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025400
Receipt No. R000029238
Scientific Title A verification study of effective on anti-aging: A open trial
Date of disclosure of the study information 2016/12/26
Last modified on 2017/11/16

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Basic information
Public title A verification study of effective on anti-aging: A open trial
Acronym A verification study of effective on anti-aging
Scientific Title A verification study of effective on anti-aging: A open trial
Scientific Title:Acronym A verification study of effective on anti-aging
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the effects of the concentration of serum IGF-1 and DHEA-S
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. Blood test
The concentration of serum IGF-1
Key secondary outcomes 1. Blood test
The concentration of serum DHEA-S

2. CT scan
Take CT scan images of the abdomen and an upper arm

3. Physical examination
Weight, BMI, body fat percentage, abdominal circumference, and bust, hips, and waist measurement

4. Degree of glycation
Measure AGEs at a lower arm

5. Subjective symptoms
Likert scale

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Duration: 8 weeks
Test materials: HGH crystal MD
Dose: 1 pack, three times a day
Administration: Take 1 pack in mouth for 40 seconds and swallow it before each meal
*If you forget ingestion HGH crystal MD, take it as soon as you remember.
Interventions/Control_2
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
30 years-old <=
Age-upper limit
50 years-old >
Gender Female
Key inclusion criteria 1. Healthy Japanese women

2. BMI level is more than 25 kg/m2

3. Those who feel fatigue, look older, and need to prevent aging
Key exclusion criteria 1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction

2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases

3. Those who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily

4. Currently taking medicines and/or herbal medicines

5. Those who are allergic to medicines and/or the test food related products

6. Those who had nip and tuck such as breast implants

7. Those who are pregnant, breast-feeding, and plan to become a pregnant

8. Those who had participated another clinical test for three months when you signed the informed consent form for this trial

9. Others considered as inappropriate for the study by the physician
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo YAMAMOTO
Organization ORTHOMEDICO Inc.
Division name R&D Department
Zip code
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL 03-3818-0610
Email kazu@orthomedico.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoko SUZUKI
Organization ORTHOMEDICO Inc.
Division name R&D Department
Zip code
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL 03-3818-0610
Homepage URL
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization Autobahn Co. Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Seishin-kai Medical Association Inc, Takara Medical Clinic
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 医療法人社団 盛心会 タカラクリニック (東京都)
Seishin-kai Medical Association Inc, Takara Medical Clinic (Tokyo)

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 26 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Tanaka M, Matsuyama J, Suzuki N, Yamashita S, Takara T. Anti-aging Effects of HGH Crystal MD, a Supplement Containing Amino Acids, in Healthy Women-An Open-label Trial-. Jpn Pharmacol Ther. 2017; 45 (10): 1697-1708.
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
2016 Year 12 Month 14 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 27 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
2016 Year 12 Month 26 Day
Last modified on
2017 Year 11 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029238

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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