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

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 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

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

Value
https://center6.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