In this study, it is hypothesized that administration of 5-ALA-Phosphate + SFC in subjects vaccinated against Covid-19 could contribute in enhancing the targeted function of the immune system, which might lead to re-activation and/or increase of the vaccination response. Thus, in the present study, we will be evaluating the safety and efficacy of 5-ALA-Phosphate + SFC in subjects receiving the Covid-19 vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
200
2 capsules in the morning after breakfast (before 11 AM) and 1 capsule in the evening after a snack or after dinner (before 8 PM) orally with water for 21 days.
No Description for the intervention
BAJ RR Hospital and Research Centre
Dombivali, Maharashtra, India
Leelawati Care Hospital-Nasik (SMO)
Nashik, Maharashtra, India
Ranka Hospital
Pune, Maharashtra, India
JNU Institute for Medical Sciences and Research Centre
Jaipur, Rajasthan, India
Adverse product reaction
To determine the safety of 21 days oral administration of 5-ALA-Phosphate + SFC in subjects vaccinated with COVID-19 vaccine.
Time frame: Day 0
Adverse product reaction
To determine the safety of 21 days oral administration of 5-ALA-Phosphate + SFC in subjects vaccinated with COVID-19 vaccine.
Time frame: Day 1
Adverse product reaction
To determine the safety of 21 days oral administration of 5-ALA-Phosphate + SFC in subjects vaccinated with COVID-19 vaccine.
Time frame: Day 7
Adverse product reaction
To determine the safety of 21 days oral administration of 5-ALA-Phosphate + SFC in subjects vaccinated with COVID-19 vaccine.
Time frame: Day 21
Absolute change in GMT of IgG levels against Covid-19 spike protein
Elecsys Anti-SARS-CoV-2 S kit will be used to measure the levels of IgG post vaccination on baseline and at the end of the study (day 21).
Time frame: Day 0 and Day 21
European Quality of Life Five Dimension Five level questionnaire
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The subject is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the subject's health state. The Lower level is denoted as 1 and the highest level is denoted as 5. The EQ-5D-5L QoL questionnaire will be completed by the subject.
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Time frame: Day 0 , Day 1, Day 7 and Day 21
World Health Organization Well-Being Index questionnaire
The 5-item World Health Organization Well-Being Index (WHO-5) is a short and generic global rating scale measuring subjective well-being.
Time frame: Day 0 , Day 1, Day 7 and Day 21
Visual Analogue Scale for pain and fatigue
The subjects is asked to place a line perpendicular to the VAS line at the point that represents their current situation for pain and fatigue (question 4). Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity
Time frame: Day 0 , Day 1, Day 7 and Day 21