Evaluation the effect of Chicory in decreasing serum Ferritin and liver enzymes in major Thalassemia patients
Design
The clinical trial is one-sided blind from the analyst's side. We have a control group that is parallel to the intervention group. Phase 3 is a clinical trial conducted on 54 patients. Randomization is done in blocks and with cards. This study is one-sided blind. In this way, the researcher and the patient know about the received treatment and there is no possibility of blinding them, but in order to avoid bias in the analysis, the analyst will not know about the codes of the treatment group to which the patients belong.
Settings and conduct
Patients admitted to the hematology department of Amirkabir Arak Hospital and with the opinion of a hematology specialist who are treatment with Chelator (routine treatment) will be included in the study. This study is one-sided blind from the analyst's side. First, the patient's serum ferritin and liver enzyme levels were measured, then chicory extract was added to the treatment of the intervention group and they received 5 cc every twelve hours, and the control patients only received routine treatment. Again, after three months, the level of liver enzyme and Fertin of patients of two groups will be measured again.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with thalassemia major and Ferrtin above 500
Exclusion criteria : allergy and hepatitis
Intervention groups
The intervention group of this study is chicory plant extract with a concentration of 417 mg per 5 cc prepared from the Faculty of Traditional Medicine of Tehran University of Medical Sciences, which is given 5 cc every twelve hours for three months to the intervention group in addition to routine medication. The control group of this study only receives the routine medicine related to the disease.
Main outcome variables
Ferritin, ALT, AST, ALK
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230704058674N1
Registration date:2023-12-21, 1402/09/30
Registration timing:prospective
Last update:2023-12-21, 1402/09/30
Update count:0
Registration date
2023-12-21, 1402/09/30
Registrant information
Name
mozhgan jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3403 5290
Email address
mozhgaanjafari1994@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of Chicory in decreasing serum Ferritin and liver enzymes in major Thalassemia patients
Public title
Investigating the effect of chicory in the treatment of thalassemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consent of patients to participate in the study
thalassemia major patients treated with periodic pack cell transfusion
ferritin>500
Exclusion criteria:
disinclination to participate or continue studying
Occurrence of skin complications or other symptoms suggestive of sensitivity to chicory plant extract
Viral hepatitis or known liver disease
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
After the identification of the patient and his permission, he is officially included in the study. The researcher has used the random bock method. In this way, patients with two treatment models
c= consumption of chicory sweat
p = not consuming chicory
And he used the table of random numbers with 6 transformations using the https://www.sealedenvelope.com site.
The numbers 1 2 3 are specific to treatment c and 4 5 6 are specific to treatment p. Zero is also ignored. For example, using the table of six random transformations:
5 1 4 3 2 6
pccpcp
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is single-blind. In this way, the researcher and the patient know about the received treatment and there is no possibility of blinding them, but to avoid bias in the analysis, the analyst will not know about the codes of the treatment group to which the patients belong.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of arak university of medical science
Street address
forth floor,mehr3 bulding, no 5 negin ave, hepco street, arak town
City
arak
Province
Markazi
Postal code
3818989489
Approval date
2023-06-20, 1402/03/30
Ethics committee reference number
IR.ARAKMU.REC.1402.076
Health conditions studied
1
Description of health condition studied
Beta Thalassemia major
ICD-10 code
D56.1
ICD-10 code description
Beta thalassemia
Primary outcomes
1
Description
ferritin
Timepoint
Initial ferritin measurement (before the start of the intervention), 3 months after consumption of chicory
Method of measurement
Biochemistry blood test
Secondary outcomes
1
Description
liver enzyme
Timepoint
Liver enzyme measurement at the beginning of the study (before consuming chicory) and three months after consuming chicory
Method of measurement
Biochemistry blood test
Intervention groups
1
Description
Intervention group: Chicory herbal extract prepared from Tehran School of Traditional Medicine with a concentration of 417 mg per cc, 5 cc every 12 hours for 3 months.
Category
Treatment - Drugs
2
Description
Control group: Not consuming Chicory
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir Hospital
Full name of responsible person
dr Mozhgan Jafari
Street address
Amirkabir Hospital,Parastar square,Rah ahan street
City
Arak
Province
Markazi
Postal code
3818989489
Phone
+98 86 3403 5290
Email
mozhgaanjafari1994@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Shaghaiegh Khodaadi
Street address
Sardasht street,
City
Arak
Province
Markazi
Postal code
3818989489
Phone
+98 86 3403 5290
Email
mozhgaanjafari1994@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Medical science of Arak university
Proportion provided by this source
10
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
mozhgan jafari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Rahahan street,Nurse Square,Amirkabir Hospital
City
Arak
Province
Markazi
Postal code
3818989489
Phone
+98 86 3403 5290
Email
mozhgaanjafari1994@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mozhgan jafari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Rahahan street,Nurse square,Amirkabir Hospital
City
Arak
Province
Markazi
Postal code
3818989489
Phone
+98 86 3403 5290
Email
mozhgaanjafari1994@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mozhgan jafari
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Rahahan street,Nurse square,Amirkabir Hospital
City
Arak
Province
Markazi
Postal code
3818989489
Phone
+98 86 3403 5290
Email
mozhgaanjafari1994@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD