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Study aim: The effect of Silybum marianum on methotrexate-induced hepatotoxicity and its analgesic effect in the patients with rheumatoid arthritis history Design: Patients will be randomly divided into intervention and control groups (30 patients in each group). The study will be Double-blind and with parallel groups .The intervention group consisted of rheumatoid arthritis patients who received 280 mg of oral silymarin daily for 2 months.The control group consisted of rheumatoid arthritis patients who received of placebo tablets the shape and packaging are quite similar to Silymarin daily for 2 months. Settings and conduct: The study will be conducted in the Rheumatology units of Amir al-Momenin hospitals. The study will be Double-blind and with parallel groups .The intervention group consisted of rheumatoid arthritis patients who received 280 mg of oral silymarin daily for 2 months.The control group consisted of rheumatoid arthritis patients who received of placebo tablets the shape and packaging are quite similar to Silymarin daily for 2 months. Participants/Inclusion and exclusion criteria: Inclusion Criteria: 1-Age between 16 and 85 2-No history of liver disease 3-taking methotrexate 4- Diagnosis of rheumatoid arthritis with criteria American Collage of Rhematology Exclusion Criteria: 1-Abnormal liver function tests at admission 2- Dissatisfaction of the patient 3- Pregnancy and lactation Intervention groups: The intervention group consisted of rheumatoid arthritis patients who received 280 mg of oral silymarin daily for 2 months.The control group consisted of rheumatoid arthritis patients who received placebo tablets the shape and packaging are quite similar to Silymarin daily for 2 months. Main outcome variables: The impact of Silybum marianum on methotrexate-induced hepatotoxicity and its analgesic effect in the patients with rheumatoid arthritis history patients will be assessed.
IRCTID: IRCT20180519039711N4
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