Protocol summary

Summary
We will discuss the effect of Medicago Sativa plant leaf on resolving anemia caused by the lack of iron. This plant has less side effects in comparison with other plants and strengthens stomach and whole body. It is claimed that this plant has twice as much iron than spinach.In this research, two thirty member group of male participants are used. The general characteristics of the member for being studied are being healthy, adult and male. The general characteristic of the member for being removed from the research group is not taking the drug on time. With the oral intake of two plant extract capsules by the participants and testing their blood parameters in time intervals, the effect of plant is studied. In this research blinding is done for the participants who take the capsules. In this research Method: 1-Collecting plant leaves and preparing capsules 2-Choosing two 30-member group of healthy men for using the drug and plasebo 3- Blood analysis before taking plasebo and drug and after two to four weeks after taking them 4- Statistical analysis of the results.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201408317803N2
Registration date: 2015-02-02, 1393/11/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-02-02, 1393/11/13
Registrant information
Name
Faraz Mojab
Name of organization / entity
Shahid Beheshty University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 0061
Email address
sfmojab@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research -Shahid Beheshti University of Medical Science faculty of pharmacy
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2014-12-06, 1393/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral intake of Medicago Sativa plant leaf on blood factors related to anemia
Public title
The effect of Medicago Sativa plant on anemia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Mature healthy person Exclusion criteria: Failure to use capsules
Age
No age limit
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
College of Pharmacy- Shahid Beheshti University
Street address
Niayesh high way, Valiasr ave
City
Tehran
Postal code
Approval date
2014-09-28, 1393/07/06
Ethics committee reference number
157

Health conditions studied

1

Description of health condition studied
anemia
ICD-10 code
D50
ICD-10 code description
Iron deficiency anaemia

Primary outcomes

1

Description
Hb
Timepoint
Blood sampling from test subjects, before taking capsules then two and four weeks after that
Method of measurement
analysis of blood samples

2

Description
Hct
Timepoint
Blood sampling from test subjects, before taking capsules then two and four weeks after that
Method of measurement
analysis of blood samples

3

Description
MCV
Timepoint
Blood sampling from test subjects, before taking capsules then two and four weeks after that
Method of measurement
analysis of blood samples

4

Description
MCH
Timepoint
Blood sampling from test subjects, before taking capsules then two and four weeks after that
Method of measurement
analysis of blood samples

5

Description
MCHC
Timepoint
Blood sampling from test subjects, before taking capsules then two and four weeks after that
Method of measurement
analysis of blood samples

Secondary outcomes

empty

Intervention groups

1

Description
500 miligram oral capsules should be taken twice a day for a period of one month
Category
Treatment - Drugs

2

Description
500 miligram starch oral capsules should be taken twice a day for a period of one month
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti University College of Pharmacy
Full name of responsible person
Faraz Mojab
Street address
Valiasr Ave. Niayesh high way
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Faraz Mojab
Street address
Valiasr Ave. Niayesh high way
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Faraz Mojab
Position
Phd Pharmacognosy
Other areas of specialty/work
Street address
Valiasr Ave. Niayesh high way
City
Tehran
Postal code
Phone
+98 21 8820 0120
Fax
Email
sfmojab@yahoo.com/ fatemehagaah@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Faraz Mojab
Position
Phd pharmacognosy
Other areas of specialty/work
Street address
Valiasr Ave. Niayesh high way
City
Tehran
Postal code
Phone
+98 21 8820 0120
Fax
Email
sfmojab@yahoo.comfatemehagaah@gmail.com/ fatemehagaah@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
fatemeh agah
Position
Generic pharmacy student
Other areas of specialty/work
Street address
Valiasr Ave. Niayesh high way
City
Tehran
Postal code
Phone
+98 21 2246 1200
Fax
Email
fatemehagaah@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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