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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000033381 |
Receipt No. | R000038003 |
Scientific Title | A clinical trial for 8 continuous weeks intake of HK1502 that are solid preparations blended with vitamin. |
Date of disclosure of the study information | 2019/08/01 |
Last modified on | 2019/09/10 |
Basic information | ||
Public title | A clinical trial for 8 continuous weeks intake of HK1502 that are solid preparations blended with vitamin. | |
Acronym | A clinical trial for 8 continuous weeks intake of HK1502. | |
Scientific Title | A clinical trial for 8 continuous weeks intake of HK1502 that are solid preparations blended with vitamin. | |
Scientific Title:Acronym | A clinical trial for 8 continuous weeks intake of HK1502. | |
Region |
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Condition | ||
Condition | Not applicable | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate efficacy and safety of HK1502 that are solid preparations blended with vitamin on 8 continuous weeks intake in japanese healthy adult male and female. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | *Skin AGE fluorometry
*Doctor's findings such as subjective or objective symptoms and medical observations after the clinical trial start |
Key secondary outcomes | *Questionnaire survey(five-point scale)
*Physical examinations such as height, body weight, blood pressure and others *Subject diary(doctor's findings such as expression presence or absence of adverse events) |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | NO |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Prevention | |
Type of intervention |
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Interventions/Control_1 | Each subjects consumed HK1502 that are solid preparations blended with vitamin for 8 continuous weeks. | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1)Subjects(japanese male and female) who are able to show their willingness of participating to the clinical trial, and who are able to obtain written consent to participate in the clinical trial after understanding explanation of the clinical trial.
2)Subjects who aged 35 years-old to 65 years-old. 3)BMI 18.5 more. 4)Subjects who are not regularly consuming supplements that are some possibility of having a negative influence on the clinical trial, or who are able to stop the supplements from two weeks before the clinical trial start to the end of the clinical trial. 5)The right hand is dominant hand. |
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Key exclusion criteria | 1)Subjects who suffer any disease at present and who are going to take continuous medical treatments during the clinical trial, or who are going to use the over-the-counter drug.
2)Subjects who have trauma on the middle fingertip of the left hand, and who have a negative influence on the skin AGE fluorometry. 3)Subjects who have hypersensitivity or allergic reaction to a certain drug medicine or food. 4)Subjects who have an operation career such as hepatectomy, gastrectomy, gastrointestinal suturesin, intestinal resection, transplanting and others in a digestive organ. 5)Subjects who have impaired respiratory and cardiovascular organ. 6)Subjects with experience of alcoholism, or who drink liquor excessively(pure alcohol conversion : over-60g per day). 7)Subjects who have participated in other clinical trials and use tests that apply foods and others within the last 12 weeks prior to the current clinical trial. 8)Subjects who apply to the following. (1)Male subjects who donated 400ml of blood within the last 12 weeks prior to the current clinical trial. In female, within the last 16 weeks. (2)Subjects who donated 200ml of blood within the last 4 weeks prior to the current clinical trial. (3)Subjects who donated components of blood such as blood platelet and blood plasma within the last 2 weeks prior to the current clinical trial. (4)Subjects who have had experiences of a blood collecting conforming to the above matters. 9)Subjects who are the pregnant or breast-feeding woman. 10)Subjects who are planning to become the pregnant woman during the clinical trial. 11)Others who have been determined ineligible or undesirable by investigator. |
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Target sample size | 23 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | DAIICHI SANKYO HEALTHCARE CO., LTD. | ||||||
Division name | R&D Department | ||||||
Zip code | 103-8234 | ||||||
Address | 3-14-10 Nihonbashi Chuo-ku, Tokyo 103-8234, JAPAN | ||||||
TEL | 03-5255-6330 | ||||||
yamaguchi.tomohiko.m6@daiichisankyo-hc.co.jp |
Public contact | |||||||
Name of contact person |
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Organization | Derma Labo, inc. | ||||||
Division name | headquarter | ||||||
Zip code | 060-0001 | ||||||
Address | 2 Kita 1-jo, Nishi 5-chome, Chuo-ku, Sapporo, Hokkaido 060-0001, JAPAN | ||||||
TEL | 011-205-0781 | ||||||
Homepage URL | |||||||
Y.Katsumata@dermalabo.co.jp |
Sponsor | |
Institute | Kojinkai, Association of Medical Corporation
Hosui General Medical Clinic. |
Institute | |
Department |
Funding Source | |
Organization | DAIICHI SANKYO HEALTHCARE CO., LTD.
R&D Department |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | Health Sciences Research Institute, Inc. |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Institutional Review Board of Hosui General Medical Clinic |
Address | 1-4, Nishi 2-chome, Minami 7-jo, Chuou-ku,Sappro 064-0807, Japan |
Tel | 011-530-0011 |
h.fujita@dermalabo.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 | デルマラボ株式会社(北海道)Derma Labo, inc.(Hokkaido prif.) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | 23 |
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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038003 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |