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IRCT20200923048815N1 IRCT 2020-10-15 Esfahan University of Medical Sciences The effect of synbiotic on inflammatory markers and clinical manifestations in patients with C0VID-19 Evaluation of the complementary effect of synbiotic adjuvant on inflammatory markers and clinical manifestations in patients with COVID-19 2020-10-22 anticipated 80 Complete https://irct.ir/trial/51166 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A randomization method will be used to allocate participants to the groups with a 1:1 allocation using random allocation software (RAS). Similar sealed envelopes will be used to conceal the allocation in a sequentially numbered package, Blinding description: In this study, participants, patient's clinical caregiver, outcome assessor, and data analyst were unaware of drug or placebo use. 2-3 Coronavirus infection. Intervention 1: Intervention group: Patients in this group use Lactocar brand Synbiotic in the form of 250 capsules containing 7 probiotic strains. Two capsules are consumed every day after lunch for 8 weeks. Intervention 2: Control group: Patients in this group use placebo for 8 weeks. Yes - There is a plan to make this available What will be shared: Information about the main outcome is shared. When: The start of the information access period is after the results are published. To whom: Researchers working in academic institutions and artisans can access information. Conditions: The use of information in scientific articles is unrestricted. Where to obtain: After the article is published, the information is available through reputable scientific sites. How to obtain: After the article is published, the information is available through reputable scientific sites. Comments:
public Majid Aghadavood Marnani
Soffeh Blvd, Alzahra Hospital
Esfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 Majid.aghadavood@gmail.com Esfahan University of Medical Sciences scientific Masha Khodadoostan Shahraki
Soffeh Blvd, Alzahra Hospital
Esfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 mkhodadoostan@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Age 18-70 years old Basic literacy Writing ability and healthy memory Mental conditions for continuing to attend the study and completing the consent form 18 years 70 years Both Simultaneous participation in other clinical trial studies Having other acute and serious diseases Regular and periodic consumption of special dietary supplements or special diets Taking other probiotic supplements Receive corticosteroids in full dose People with pancreatitis, sepsis, dialysis, central venous and chronic diarrhea People waiting for abdominal surgery People with acute immune deficiencies such as AIDS People with short bowel syndrome or are at risk for mesenteric ischemia Pregnant women and mothers who are breastfeeding. B34.2 Coronavirus infection, unspecified Treatment - Drugs Placebo Intervention group: Patients in this group use Lactocar brand Synbiotic in the form of 250 capsules containing 7 probiotic strains. Two capsules are consumed every day after lunch for 8 weeks. Control group: Patients in this group use placebo for 8 weeks. Inflammatory markers. Timepoint: Before and 8 weeks after start of intervention. Method of measurement: Biochemical analysis. Clinical symptoms. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Comment by physician. Esfahan University of Medical Sciences Approved 2020-05-30 Ethics committee of Isfahan University of Medical Sciences Soffeh Blvd, Alzahra Hospital Esfahan Isfehan Iran (Islamic Republic of)