Investigating the effect of Syrup based on Naqu Fawakeh on liver enzymes in children with ALL undergoing chemotherapy ,a double blind randomized controlled trial.

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 106

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.