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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039023
Receipt No. R000044500
Scientific Title Effects of Continuous Intake of Dried Olive Leaf Tea on Hematological Parameters -A Comparison Study Among Three Random Groups in Bangladesh-
Date of disclosure of the study information 2020/01/27
Last modified on 2020/01/16

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Basic information
Public title Effects of Continuous Intake of Dried Olive Leaf Tea on Hematological Parameters -A Comparison Study Among Three Random Groups in Bangladesh-
Acronym The Study of Continuous Intake of Dried Olive Leaf Tea
Scientific Title Effects of Continuous Intake of Dried Olive Leaf Tea on Hematological Parameters -A Comparison Study Among Three Random Groups in Bangladesh-
Scientific Title:Acronym The Study of Continuous Intake of Dried Olive Leaf Tea
Region
Asia(except Japan)

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

Objectives
Narrative objectives1 To investigate the effects of continuous intake of dried olive leaf tea in hematology parameters in healthy to mildly anemic young people in Bangladesh.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Change in hemoglobin (Hb) concentration 12 weeks after intervention
Key secondary outcomes 1) Change in Hb concentration 6 weeks after intervention
2) Change in red blood cell count (RBC) 6 and 12 weeks after intervention
3) Change in White blood cell count, hematocrit, MCV, MCH, MCHC, serum iron concentration, serum ferritin concentration, and lipid profile 6 and 12 weeks after intervention
4) Changes in score of each item of FAS questionnaire after 6 and 12 weeks of intervention

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Placebo(12weeks)
Interventions/Control_2 Low dose dried olive leaf tea(12weeks)
Interventions/Control_3 Normal dose dried olive leaf tea(12weeks)
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
15 years-old <=
Age-upper limit
59 years-old >=
Gender Male and Female
Key inclusion criteria 1) Those who are 15 to 59 years old.
2) Those who will provide written consent to participate in this research.
Key exclusion criteria 1) If you are currently pregnant or breastfeeding or have the possibility within 4 months.
2) For those with moderate to severe anemia (hemoglobin concentration less than 10 g / dL for women and less than 11 g / dL for men).
3) Those who have any of the medical conditions, such as hematological diseases, malignant tumors, aplastic anemia, uncontrolled hypertension, chronic kidney disease, irritable bowel syndrome, and cardiovascular diseases.
4) Those who are currently taking medicine for diabetes or hypertension drugs.
5) If you currently use iron or other supplements regularly.
6) If you are participating in other clinical trials.
7) Those who may move out of the research area within 4 months.
8) Those who are considered as ineligible by the study physician.
Target sample size 165

Research contact person
Name of lead principal investigator
1st name Hiroko
Middle name
Last name Isoda
Organization University of Tsukuba
Division name Faculty of Life and Environmental sciences
Zip code 305-8577
Address 1-1-1 Tennodai, Tsukuba, Ibaraki
TEL +81-029-853-7871
Email isoda.hiroko.ga@u.tsukuba.ac.jp

Public contact
Name of contact person
1st name Farhana
Middle name
Last name Ferudousi
Organization University of Tsukuba
Division name Research Center for Mediterranean and North African Studies
Zip code 305-8577
Address 1-1-1 Tennodai, Tsukuba, Ibaraki
TEL +81-029-853-7871
Homepage URL
Email ferdousi.farhana.fn@u.tukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
Name of secondary funder(s) Japan Science and Technology Agency (JST) and the Japan International Cooperation Agency (JICA) (SATREPS)

IRB Contact (For public release)
Organization Ethics Committee of University of Tsukuba Hospital
Address 2-1-1 Amakubo, Tsukuba, Ibaraki
Tel +81-029-853-3914
Email chiken@un.tsukuba.ac.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 International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)

Other administrative information
Date of disclosure of the study information
2020 Year 01 Month 27 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
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 Preinitiation
Date of protocol fixation
2019 Year 12 Month 18 Day
Date of IRB
Anticipated trial start date
2020 Year 01 Month 28 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 12 Month 27 Day
Last modified on
2020 Year 01 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044500

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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