Efficacy and safety of "BioBoost" supplement on the incidence of COVID-19 symptoms of asymptomatic family members of COVID-19 patients
IRCT; 2021-01-12; TrialID: IRCT20200318046812N3
Clinical Trial Register
| ICTRP | ID: ictrp-IRCT20200318046812N3
ABSTRACT
Condition
COVID-19.COVID-19, virus identified;U07.1
Intervention
Intervention 1 ''Intervention group'' In this group, probiotics are given to the patients' families. Biomus supplement consists of 12 essential vitamins and minerals along with probiotics (a mixture of three native Iranian strains including Lactobacillus casei, L. rhamnosus and L. helveticus ). All these items are prepared in one capsule to strengthen the immune system and digestive system against viral and bacterial diseases.Three capsules of medicine/placebo are delivered daily to the participants after receiving informed consent and the eligibility of the cluster at the initial visit. In follow-up visits, after receiving the previous drug pack/placebo, the new treatment is sent to the patient's family using a courier. The amount of medicine/placebo delivered is enough until the next visit. Intervention 2 ''Control group'' Placebo is given to patients three times a day.Primary outcome:
?S?everity of cough. Timepoint The variable in the drug and placebo groups can be recorded at the end of the first, second and fourth weeks. Method of measurement Telephone followup.;?Severity of shortness of breath. Timepoint The variable in the drug and placebo groups can be recorded at the end of the first, second and fourth weeks. Method of measurement Telephone followup.Criteria
Inclusion criteria Confirmation of infection by PCR in a family memberInformed written consent
Living in Tehran
Number of family members between 2 and 5
Age between 18 to 63 years
No prognostic signs of Covid-19 disease two weeks before enrollment
Exclusion criteria Not participating in another clinical trial in the last three months
Do not use other supplements (containing vitamins, minerals, and probiotics)
No documented history of Covid-19 infection in healthy family members
Pregnancy / breastfeeding
Drug sensitivity to the compounds in the intervention
Temporary residence or immigration and consecutive relocation from Tehran
Use similar supplements
Collection:
Clinical trial registers
Database:
ICTRP
Year:
2021
Document Type:
Clinical Trial Register
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