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

Evaluateing the Effects of CoQ10, melatonin, vitamin B groups, vitamin D. and probiotic on reducing COVID-19 symptoms during recovery

80 participants (no=40 per group) are randomly assigned to intervention and placebo group using random digit table

This double blinded study will be performed in private clinic. At base line and after 30 days of intervention with supplement/placebo, Fatigue Severity Scale (FSS) for fatigue, Pittsburgh Sleep Quality Index (PSQI) for sleep, Hospital Anxiety and Depression Scale (HADS) for anxiety , Patient Assessment of Constipation‐Symptoms (PAC-SYM) for constipation will be completed. Severity (using visual analog scale-VAS), duration, and frequency of headache will be recorded.

Inclusion criteria: diagnosed with COVID-19 according to WHO criteria; willing to participate in the study; age 18 years and older. Exclusion criteria: 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.

Patients will receive CoQ10, melatonin, vitamin B groups, vitamin D and probiotic 1000 mg capsule (Viralian Group company) or placebo BD for 30 days. Placebo contains maltodextrine.

ُScore of Fatigue Severity Scale (FSS) for fatigue; Pittsburgh Sleep Quality Index (PSQI) for sleep; Hospital Anxiety and Depression Scale (HADS) for anxiety; Patient Assessment of Constipation‐Symptoms (PAC-SYM) for constipation Severity (using visual analog scale-VAS); duration, and frequency of headache

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

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

All data would be available to public

starting 6 months after publication

To all

No other critaria

Email to soodehrazeghi@gmail.com

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