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IRCT20140804018677N21 IRCT 2022-06-26 Shahid Beheshti University of Medical Sciences Effects of CoQ10, melatonin, vitamin B groups, vitamin D. and probiotic on reducing COVID-19 symptoms during recovery Evaluating the Effects of CoQ10, melatonin, vitamin B groups, vitamin D. and probiotic on reducing COVID-19 symptoms during recovery- A randomized double blind controlled Clinical Trial 2022-05-05 anticipated 80 Complete https://irct.ir/trial/63195 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will have equal chance to be assigned to studied groups. We will use random digits table to make random sequence. After determining the first number, we will continue downward and allocate even numbers to cases and odd numbers to placebo. As in small sample sizes, it would be probable that one group be completed earlier, if one group completed earlier, we will allocate the other assigned numbers to other group. A person out of study group will put her figure on one digit of the table with closed eyes and according to assumed agreement will go downward through the table and write the numbers down until completing the sample size in each group. Code "A" will allocated to even numbers and considered as "intervention group" and code "B" will allocated to odd numbers and considered as "placebo group". At the end we will have the sequence of 80 specific numbers and A&B codes. A person out of study team will put the numbers in sealed packets till the time of sampling, Blinding description: It is a double blind study. A third person out of study team have the sequence of codes that provide the team with sealed pockets containing allocation code (supplement and placebo) at the time of sampling. The following groups of people: participants, research team including principle investigator, data collectors, and outcome assessors will be blind. 3 COVID-19. Intervention 1: Intervention group: 1000 mg capsul of CoQ10, melatonin, vitamin B groups, vitamin D. and probiotic capsule (Viralian Group company) BD for 30 days. Intervention 2: Control group: 1000 mg capsul of placebo (Viralian Group company) BD for 30 days. Yes - There is a plan to make this available What will be shared: All data would be available to public When: starting 6 months after publication To whom: To all Conditions: No other critaria Where to obtain: Email to soodehrazeghi@gmail.com How to obtain: sending email to me Comments:
public Soodeh Razghei Jahromi
No. 7, West Arghavan St., Farahzadi Blv., Qods Town
Tehran Iran (Islamic Republic of) 193954741 +98 21 2235 7483 soodehrazeghi@gmail.com Nutrition and food science faculty, Shahid Beheshti University of Medical Sciences scientific Soodeh Razghei Jahromi
No. 7, West Arghavan St., Farahzadi Blv., Qods Town
Tehran Iran (Islamic Republic of) 193954741 +98 21 2235 7483 soodehrazeghi@gmail.com Nutrition and food science faculty, Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Diagnosed with COVID-19 according to WHO criteria Willing to participate in the study Age 18 years and older 18 years no limit Both Discharged with positive PCR test for COVID-19 Pregnancy Lactation Vitamin D deficiency based on lab test (<30 ng/ml) Enteral or parental nutrition requirement after discharge U07.1 COVID-19, virus identified Treatment - Other Placebo Intervention group: 1000 mg capsul of CoQ10, melatonin, vitamin B groups, vitamin D. and probiotic capsule (Viralian Group company) BD for 30 days Control group: 1000 mg capsul of placebo (Viralian Group company) BD for 30 days Fatigue Severity. Timepoint: Baseline and at the end of the study. Method of measurement: Fatigue Severity Scale (FSS). Sleep Quality. Timepoint: Baseline and at the end of the study. Method of measurement: Pittsburgh Sleep Quality Index (PSQI). Anxiety. Timepoint: Baseline and at the end of the study. Method of measurement: Hospital Anxiety and Depression Scale (HADS). Constipation. Timepoint: Baseline and at the end of the study. Method of measurement: Patient Assessment of Constipation‐Symptoms (PAC-SYM). Headache severity. Timepoint: Baseline and at the end of the study. Method of measurement: Visual analog scale-VAS. Headache duration. Timepoint: Baseline and at the end of the study. Method of measurement: Headache diary. Headache Frequency. Timepoint: Baseline and at the end of the study. Method of measurement: Headache diary. Shahid Beheshti University of Medical Sciences Approved 2022-02-27 Research Ethics comittees of vice-cancellor in Research Affairs-Shahid Beheshti University of Medica 7th Floor, Bldg No.2, Shahid Beheshti University of Medical Sciences, Arabi Ave, Daneshjoo Blvd, Velenjak Tehran Tehran Iran (Islamic Republic of)