UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039056 |
|---|---|
| Receipt number | 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 09:50:46 |
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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
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
h-kayama@imeqrd.co.jp
Sponsor or person
Institute
imeQ RD inc.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044541
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| Registered date | File name |
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