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Study aim:
Evaluation of the effect of silymarin nanomicels as adjuvant therapy on Covid patients 19
Design:
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 50 patients. random.org was used for randomization.
Settings and conduct:
This research will be conducted in Imam Reza Hospital of Mashhad and Imam Reza Hospital of AJA. The clinical trial research will be performed on 50 patients in a double-blind manner, and the placebo will be exactly the same as the main drug in terms of shape and color. Patients, physicians, and nurses who evaluate the outcomes will be blind to the groups studied.
Participants/Inclusion and exclusion criteria:
inclusion criteria:
- patients with the clinical diagnosis or laboratory of covid-19, and have an indication for hospitalization.
age between 18 to 75
-Signing an informed consent form
exclusion criteria:
- Pregnancy and lactation
- Active liver disease
- Severe renal failure GFR <30 ml/min
- Inability of the patient to swallow oral medication
Intervention groups:
Intervention group: COVID-19 pneumonia receiving standard of care as per Ministry of Health Protocol of Treatment + Silymarin nanomicelles 70 mg from Nano Exir Sina Company/ three times a day
control group: COVID-19 pneumonia receiving standard of care as per Ministry of Health Protocol of Treatment + placebo which is the same in shape and taste from Nano Exir Sina Company/ three times a day
Main outcome variables:
1.time to clinical improvement
2.length of Hospitalization
3.mortality rate