UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039023 |
|---|---|
| Receipt number | 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 10:48:43 |
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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
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
ferdousi.farhana.fn@u.tukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044500
