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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039056
Receipt No. R000044541
Scientific Title An open label study of efficacy and safety of plant extracts given to individuals with anemia symptoms.
Date of disclosure of the study information 2020/01/06
Last modified on 2020/07/06

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Basic information
Public title An open label study of efficacy and safety of plant extracts given to individuals with anemia symptoms.
Acronym A study on efficacy of plant extract intake on anemia symptoms.
Scientific Title An open label study of efficacy and safety of plant extracts given to individuals with anemia symptoms.
Scientific Title:Acronym A study on efficacy of plant extract intake on anemia symptoms.
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of 8-week intake of test food in healthy females (aged 20-49) with anemia symptoms.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood tests (hemoglobin, ferritin, red blood cell count, serum iron, hematocrit)
Key secondary outcomes Two types of questionnaires about subjective symptoms.

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 Prevention
Type of intervention
Food
Interventions/Control_1 Take 4 test food tablets once daily with a glass of water or lukewarm water after having breakfast.
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
20 years-old <=
Age-upper limit
50 years-old >
Gender Female
Key inclusion criteria 1. 20 to 49 years old (at the time of submission of an informed consent document).
2. Japanese females.
3. Those who have subjective symptoms of anemia and are allowed to participate in this study by the principal investigator.
4. Those who can take test food for 8 weeks.
5. Smartphone or PC users (who can input their own data into the electronic diary).
6. Those who can receive sufficient explanation of the purpose and content of this study, who have ability to agree with the above explanation, who voluntarily participate in this study after coming to a better understanding, and who can give written informed consent.
7. Those who are regarded as not ill and allowed to participate in this study by the principal investigator or a sub-investigator.
Key exclusion criteria 1. Those who are currently receiving some types of drug and Chinese medical treatments (except for the drugs that are taken as needed).
2. Those who have or had a severe disease of the liver, heart, kidneys, gastrointestinal tract, respiratory system, endocrine, and metabolism (except for appendicitis).
3. Those who may have allergic reactions to test food.
4. Those who have a past medical history of treatment for heart failure, heart attack, etc.
5. Those who are currently taking health food (such as supplements or food products to maintain or restore health), except for those who can temporarily stop taking the above health food at the time of submission of an informed consent document and remain the same until the end of this study.
6. Those who have a past and current medical history of drug or food allergy.
7. Those who are currently participating in another clinical trial or who had participated in another clinical trial conducted within a month prior to the submission of an informed consent document.
8. Those who are currently pregnant or breastfeeding and who want to become pregnant.
9. Heavy drinkers.
10. Smokers.
11. Those who experienced a feeling of being unwell or deterioration of health condition when they had blood drawn.
12. Those who may undergo lifestyle changes (such as a long trip) during the study period.
13. Those who were determined by the principal investigator to be unsuitable for participation in this clinical trial.
Target sample size 8

Research contact person
Name of lead principal investigator
1st name Sofya
Middle name
Last name Suidasari
Organization Nutrition Act.Co.,Ltd.
Division name Nutraceuticals Research Office
Zip code 104-0061
Address 3F Office floor, Daiwa Royal Ginza Bldg.1-13-15 Ginza, Chuo-ku, Tokyo
TEL 03-3538-5811
Email sofya-s@n-act.co.jp

Public contact
Name of contact person
1st name Hirokuni
Middle name
Last name Kayama
Organization imeQ RD inc.
Division name Sales department
Zip code 169-0051
Address 2-14-6, Nishi-Waseda, Shinjyuku, Tokyo, Japan
TEL 03-6205-6222
Homepage URL
Email h-kayama@imeqrd.co.jp

Sponsor
Institute imeQ RD inc.
Institute
Department

Funding Source
Organization Nutrition Act.Co.,Ltd.
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
Tel 03-6205-6222
Email suda-clinic_irb@imeq.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
2020 Year 01 Month 06 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 8
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
2019 Year 12 Month 13 Day
Date of IRB
2019 Year 12 Month 16 Day
Anticipated trial start date
2020 Year 01 Month 21 Day
Last follow-up date
2020 Year 03 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 01 Month 05 Day
Last modified on
2020 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044541

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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