Elevation of liver enzymes caused by chemotherapy. Toxic liver disease with hepatitis, not elsewhere classified
Conditions
Interventions
Intervention 1: Intervention group: Intervention group: Naqu Fawake syrup containing Bukhara plums, black plums, mangosteens, jujubes, jaggery, tamarinds, apricots, and red sugar, which is currently m
Sponsors
Shiraz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
5 Years to 17 Years
Inclusion criteria
Inclusion criteria: Patients with ALL based on bone marrow aspiration and immunophenotype, aged 5 to 17 years, in the maintenance phase of treatment by methotrexate and 6-mercaptopuril, with liver enzymes level 2 times or more higher than the maximum normal level Willingness to participate in the study .
Exclusion criteria
Exclusion criteria: The occurrence of any allergy and intolerance to the drug. Diagnosis of liver disease during planning. The patient's unwillingness to continue treatment. Taking drugs that interfere with the herbs in the composition. history of drug sensitivity to the plants in the syrup:Prunus cerasus,Prunus domestica,Alhagi pseudalhagi ,Zizyphus jujube,Cordia myxa ,Tamarindus indica,Prunus armeniaca,Saccharum officinarum The patient has diarrhea. (CTCAE questionnaire)[39] history of liver disease, viral hepatitis, HIV, diabetes, other malignancies, and chronic intestinal disease. Taking drugs with the risk of cholestatic liver damage or damaging liver cells: drugs causing liver cholestasis: amoxicilline and clavulanic acid with consumption of more than 90 mg per kilogram per day, anabolic steroids, chlorpromazin, clopidogrel, erythromycin, irbesartan, mirtazapine, estrogen , terbinafine, drugs that damage liver cells and cause liver cholestasis, amitriptyline, azathioprine: captopril, carbamazepine, clindamycin, co-trimoxazole, cyproheptadine, enalapril, flutamide, nitrofurantoin, phenobarbital, phenytoin, sulphonamide, trazodone, verapamil
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alanine transaminase (ALT). Timepoint: before the start of the intervention and 28, 84, 56 days after the start of the drug. Method of measurement: Blood test.;Aspartate transaminase(ASP). Timepoint: before the start of the intervention and 28, 84, 56 days after the start of the drug. Method of measurement: Blood test.;Alkaline Phosphatase( ALP ). Timepoint: before the start of the intervention and 28, 84, 56 days after the start of the drug. Method of measurement: Blood test. | — |
Secondary
| Measure | Time frame |
|---|---|
| Constipation. Timepoint: At the beginning of the study (before the start of the intervention) and 28, 56, 84 days after the start of the drug. Method of measurement: Criteria Terminology Common For Adverse Events (CTCAE) version4 ,questionnaire.;Nausea and Vomiting. Timepoint: At the beginning of the study (before the start of the intervention) and 28, 56, 84 days after the start of the drug. Method of measurement: MAT questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactYasman Vazani
Shiraz University of Medical Sciences
Outcome results
None listed