Study on oral syrup of extract Cichorium intybus root on decreasing liver enzymes in thalassemia patients in Mohammad Kermanshahi hospital of Kermanshah city.
The effect of oral administration of chicory extract on serum levels of AST and ALT in patients with thalassemia.
Design
Clinical trial with control group, with parallel, blinded and randomized groups
Settings and conduct
Patients are routinely referred for LFT and ferritin measurements every three months.
After obtaining written consent from patients, the level of ferritin and liver enzymes will be measured and recorded.
Then people with random allocation will be divided into two groups. In the first group (intervention) patients will receive chicory extract as a medicinal supplement. The amount of chicory extract will be evaluated based on the BMI of the patients. Containing 200 mg in 5 ml of chicory extract will be prescribed.
In the second group (control) patients will be given a placebo for three months
The chicory or placebo extract will be prescribed as a supplement.
Liver enzymes levels will be measured at baseline, one and a half months later, three months later, and six months later. Ferritin levels will be measured at baseline, three months, and six months later.
Participants/Inclusion and exclusion criteria
The study population will be patients with thalassemia referred to Dr. Mohammad Kermanshahi Hospital.
Entry requirements: AST and ALT impaired
Exclusion criteria: high ferritin 2, liver failure or viral hepatitis
Intervention groups
Intervention group: Blood transfusion-dependent thalassemic patients with abnormal liver enzymes are treated with chicory extract for three months and their liver enzymes are evaluated.
Control group: Blood transfusion-dependent thalassemia patients with impaired liver enzymes receive placebo in addition to their medications for three months and their liver enzymes are evaluated.
Main outcome variables
Amount of decrease liver enzymes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111001007677N6
Registration date:2020-02-13, 1398/11/24
Registration timing:registered_while_recruiting
Last update:2020-02-13, 1398/11/24
Update count:0
Registration date
2020-02-13, 1398/11/24
Registrant information
Name
Mohamadreza Golpayegani
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6331
Email address
golpayegani@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-20, 1398/10/30
Expected recruitment end date
2020-02-19, 1398/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study on oral syrup of extract Cichorium intybus root on decreasing liver enzymes in thalassemia patients in Mohammad Kermanshahi hospital of Kermanshah city.
Public title
Study on oral syrup of extract Cichorium intybus root on decreasing liver enzymes in thalassemia patients in Mohammad Kermanshahi hospital of Kermanshah city.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
major and intermediate thalassemic pations with abnormal AST and ALT
Exclusion criteria:
liver failure
viral hepatitis
ferritin level more than 3000
Age
From 2 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization and random assignment of people to two groups is done by generating random numbers using the random number table. That is, the participants in the study were divided into intervention and control groups by simple and individual randomization with the help of random number table. In this method, the person assigned to the first selected number (randomly) is placed in the intervention group and the person assigned to the next selected number (randomly) is assigned to the control group and this process until the end of assignment of people to two groups. Intervention and control continue.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants in the study and the data analyzer are blind for drug or placebo administration. Medication and placebo had the same packaging, taste, volume, and color.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Building No.2, Kermanshah University of Medical Sciences, Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6719851115
Approval date
2019-12-17, 1398/09/26
Ethics committee reference number
IR.KUMS.REC.1398.895
Health conditions studied
1
Description of health condition studied
thalassemia disease
ICD-10 code
D56
ICD-10 code description
Thalassemia
Primary outcomes
1
Description
Aspartate aminotransferase
Timepoint
At baseline, one and a half months later, three months later, six months later
Method of measurement
ELISA method and iranian science antibody kits
2
Description
Alanin aminotransferase
Timepoint
At baseline, one and a half months later, three months later, six months later
Method of measurement
ELISA method and iranian science antibody kits
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients will receive chicory extract as a medicinal supplement. The amount of chicory extract will be evaluated based on the BMI of the patients. Gram will be administered in 5 ml of chicory extract. The chicory extract is manufactured and standardized by the Razi University School of Pharmacy.
Category
Treatment - Drugs
2
Description
Control group:Patients in the control group will receive placebo at the rate of twenty-eight milligrams per kilogram of body weight. The placebo will be developed and standardized by Razi University School of Pharmacy.