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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.