Protocol summary

Summary
In patients with iron deficiency anemia who have been diagnosed by clinical symptoms and laboratoryAbout the study explained and justified them by the end of informed consent based on inclusion criteria (Obtaining the informed consent of the patient-Having iron deficiency anemia)After completing the questionnaire, patients 5cc blood was taken for testing base Then, patients randomly divided into 2 groups of 60 to 12 weeks cost them a herbal preparation Iron Plus 325 mg (3 tablets a day ) and one Ferfolic at a dose of 325mg (3 tablets a day ) will receiveAfter 12 weeks, blood tests every month Shvd.bymar repeated every 15 days in person and by telephone monitoredCheck prove possible complications , which are recorded in ADR formExclusion criteria from the study is that more than 3 weeks off the drug or herbal preparation not possible sensitivity. goals are determine the comparison of the efficiency and effectiveness and side effects of herbal products containing Fe ( Iron Plus) and tablet ferfolic possible complications in patients with iron deficiency anemiaInclusion criteria are Obtaining the informed consent of the patient؛Group of iron deficiency anemia.Primary outcome variables are TIBC levels, serum transferrin level , serum iron level ferritin proto- porphyrin levels of hematocrit, hemoglobin, MCV level is a level MCH RDW . Secondary variable consequences is drug side effects.

General information

Acronym
*
IRCT registration information
IRCT registration number: IRCT201506211165N6
Registration date: 2015-09-04, 1394/06/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-09-04, 1394/06/13
Registrant information
Name
Yunes Panahi
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8821 1524
Email address
yunespanahi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Private
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2015-07-21, 1394/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy and effectiveness of combined herbal preparations containing iron ( Iron Plus tablet) in treatment of anemia in patients with iron deficiency anemia
Public title
the effect of IRONPLUS treatment of iron deficiency anemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Obtaining the informed consent of the patient؛Group of iron deficiency anemia Exclusion criteria:Failure to complete the course of treatment or use instructions
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
*

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
BAQIATALLA HOSPITAL
Street address
TEHRAN.SHEYKH BAHAI.SARE MOLASADRA
City
TEHRAN
Postal code
1435915371
Approval date
2015-03-09, 1393/12/18
Ethics committee reference number
IR.BMSU.REC.1394.54

Health conditions studied

1

Description of health condition studied
IRON DEFICIENCY ANEMIA
ICD-10 code
D50
ICD-10 code description
Iron deficiency anaemia

Primary outcomes

1

Description
FERRITIN
Timepoint
BEFORE AND AFTER OF DRUG
Method of measurement
Questionnaire

2

Description
TIBC
Timepoint
BEFORE AND AFTER OF DRUG
Method of measurement
Questionnaire

3

Description
TRANSFERIN
Timepoint
BEFORE AND AFTER OF DRUG
Method of measurement
Questionnaire

4

Description
SERUM IRON
Timepoint
BEFORE AND AFTER OF DRUG
Method of measurement
Questionnaire

5

Description
RDW
Timepoint
BEFORE AND AFTER OF DRUG
Method of measurement
Questionnaire

6

Description
HCT HB
Timepoint
BEFORE AND AFTER OF DRUG
Method of measurement
Questionnaire

7

Description
MCV MCH
Timepoint
BEFORE AND AFTER OF DRUG
Method of measurement
Questionnaire

8

Description
PROTOPURPHIRIN
Timepoint
BEFORE AND AFTER OF DRUG
Method of measurement
Questionnaire

Secondary outcomes

1

Description
SIDE EFFECTS OF DRUG
Timepoint
AFTER Prescription OF DRUG
Method of measurement
Questionnaire

Intervention groups

1

Description
to 12 weeks cost intervention group a herbal preparation Iron Plus 325 mg (3 tablets a day ) will receiveBlood tests will be repeated after 12 weeks
Category
Treatment - Drugs

2

Description
to 12 weeks cost control group and one FERFOLIC at a dose of 325mg (3 tablets a day )will receiveBlood tests will be repeated after 12 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
CLINIC OF MR. DR JALALIAN
Full name of responsible person
MR. DR JALALIAN ONCOLOGIST
Street address
*
City
TEHRAN

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
NIAC Pharmaceutical Company
Full name of responsible person
Dr. Human Bayat
Street address
Golestan state.Gorgan.Agh ghola 5 km road.NIAC Pharmaceutical Company
City
Gorgan
Grant name
Grant code / Reference number
*
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
NIAC Pharmaceutical Company
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
Baqiatala Hospital
Full name of responsible person
Mr. Dr. Yunes Panahi
Position
Professor Pharmacotherapy
Other areas of specialty/work
Street address
TEHRAN Sheykhbahai at first Molasadra
City
Tehran
Postal code
1435915371
Phone
+98 88050435
Fax
*
Email
YUNESPANAHI@YAHOO.COM
Web page address
*

Person responsible for scientific inquiries

Contact
Name of organization / entity
Baqiyatallah HospitaL
Full name of responsible person
MR. Doctor Alireza Aaadat
Position
Assistant Professor
Other areas of specialty/work
Street address
Baqiyatallah Hospital
City
Tehran
Postal code
*
Phone
*
Fax
*
Email
*
Web page address
*

Person responsible for updating data

Contact

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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