Investigation the effectiveness and non effectiveness of oral administration of chicory extract on the decrease of ferritin serum in patients with thalassemia major and intermedia
This study will be done with aim to investigate the effectiveness of oral administration of chicory extract on the decrease of ferritin serum in patients with thalassemia major an intermedia. This study is a single blind clinical trial. The study population will be included patients with thalassemia Major admitted to Mohammad Kermanshahi hospital, a total of 100 patients with thalassemia major will be selected in available method and randomly placed in two intervention and control groups. Patients in the intervention group will receive 200 mg of chicory syrup daily as a supplemental therapy along with iron chelation. In the control group 200 mg placebo will be prescribed in addition to iron chelation. Baseline, two months after the start of treatment and two months after the end of treatment, again ferritin levels will be measured in the laboratory. For measuring ferritin ELISA method and padtan elm manufactured in Iran will be used.
Inclusion criteria: Patients with thalassemia major; Patients with serum ferritin between 1000 and 3000.
Exclusion criteria: Patients with heart failure, hypertension and diabetes; Patients who have more than 3,000 ferritin in routine check
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016112514333N61
Registration date:2017-03-05, 1395/12/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-05, 1395/12/15
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
Expected recruitment start date
2017-02-03, 1395/11/15
Expected recruitment end date
2017-07-06, 1396/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effectiveness and non effectiveness of oral administration of chicory extract on the decrease of ferritin serum in patients with thalassemia major and intermedia
Public title
Study of Chicory per oral administration effect in decreasing serum Ferritin level in major and intermediate beta thalassemia patient.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with thalassemia major; Patients with serum ferritin between 1000 and 3000.
Exclusion criteria: Patients with heart failure, hypertension and diabetes; Patients who have more than 3,000 ferritin in routine check
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomly by tossing coin
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2017-02-08, 1395/11/20
Ethics committee reference number
kums.rec.1395.662
Health conditions studied
1
Description of health condition studied
Major Thalassemia
ICD-10 code
D56.1
ICD-10 code description
Beta thalassaemia
Primary outcomes
1
Description
Serum ferritin levels
Timepoint
Baseline, two months after the start of treatment and two months after the end of treatment
Method of measurement
Based on lab
Secondary outcomes
empty
Intervention groups
1
Description
Patients in the intervention group will receive 200 mg of chicory syrup daily as a supplemental therapy along with iron chelation.
Category
Treatment - Drugs
2
Description
In the control group 200 mg placebo will be prescribed in addition to iron chelation.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mohammad Kermanshahi Hospital
Full name of responsible person
Dr. Farzaneh Roostaei
Street address
Mohammad Kermanshahi Hospital, Crossroads of shirkhorshid
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farzaneh Roostaei
Position
Pediatrics Assistant
Other areas of specialty/work
Street address
Mohammad Kermanshahi Hospital, Crossroads of shirkhorshid
City
Kermanshah
Postal code
Phone
+98 83 3721 7206
Fax
Email
froosatei1985@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. mohammadreza Golpayegani
Position
Oncologyist and pediatric cancer
Other areas of specialty/work
Street address
Mohammad Kermanshahi Hospital, Crossroads of shirkhorshid
City
Kermanshah
Postal code
Phone
+98 83 3721 7206
Fax
Email
Golpayegani@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farzaneh Roostaei
Position
Pediatrics Assistant
Other areas of specialty/work
Street address
Mohammad Kermanshahi Hospital, Crossroads of shirkhorshid
City
Kermanshah
Postal code
Phone
+98 83 3721 7206
Fax
Email
froosatei1985@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)