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Study aim
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Evaluation of the effect of synbiotic supplementation on clinical manifestations, inflammatory and non-inflammatory markers in hospitalized Covid-19 patients compared with placebo
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Design
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Clinical trial with control group (placebo), with parallel groups, double-blind, randomly blocked, phase 3 on 60 patients.
The www.sealedenvelope.com was used to generate a blocked random allocation sequence.
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Settings and conduct
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This study is a randomized clinical trial and patients admitted with Covid 19 in Ghaem Hospital in Mashhad, after obtaining informed consent, patients are randomly placed in one of two intervention groups or placebo. Double-blind randomization will be done by packets in the package. According to the pre-designed checklist, patients in both groups will be followed up for 14 days from the time of admission, and clinical signs, inflammatory and non-inflammatory markers will be taken from patients on the first day and the fourteenth day of follow-up.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Conscious consent
Hospitalized patients with Covid 19
Age category 18 years and above
Exclusion criteria:
Pregnancy and lactation
Hospitalization in the ICU
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Intervention groups
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In the intervention group, patients, take two synbiotic daily for 14 days. In the placebo group, patients take two placebo daily for 14 days.
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Main outcome variables
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Levels of inflammatory factors CRP, ESR and IL-6 as well as ALT, AST, ALP, CBC, and Creatinine on the first and fourteenth day of follow-up.
Evaluation of clinical symptoms such as cough, fever, rapid breathing, sore throat, whole body pain, shortness of breath, SPO2 with and without oxygen, weakness and lethargy, abdominal pain, chest pain and gastrointestinal symptoms (diarrhea, vomiting and nausea) Daily until the end of the follow-up.