JMIR Publications

ABSTRACT

Background:

Coronavirus disease (COVID-19) is a recent major public health concern caused by the Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2), with around 4.46 crore COVID-19-positive cases and 5.30 lakh deaths in India (as on 1st February 2023). The COVID-19 vaccination drive in India was initiated in January 2021; however, an effective preventive strategy with high efficacy and immunological safety is still elusive.

Objective:

The immunogenic responses of Aresenicum album 30CH (AA30CH) in COVID-19 prophylaxis will be assessed by determining the antigen density and modulation in immunological markers and lymphocyte subsets CD3, CD4, CD8, CD24, CD27, CD-38, CD4 IFN-γ, CD4 CD17, CD4 CD25 (activated T lymphocytes), T-cells, B-cells, DCs (mature and immature) and NK cells on day 1, 5, 23,27, 45, 49 and 66. The innate and acquired immune responses will also be evaluated by a real-time reverse-transcriptase polymerase chain reaction (real-time RT-PCR) Array profiler (having 84-gene sets) before and after the study interventions. The toxicity status of study participants through hepatotoxicity, renal output, hematological parameters, and peripheral smears on days 1, 5, 23, 27, 45, 49, and 66 will be evaluated. The number of participants developing COVID-19-like symptoms as per National Centre for Disease Control (NCDC) guidelines and the number of participants testing positive for COVID-19 in RT-PCR during follow-ups in any of the three intervention schedules will be identified. Moreover, a sub-group analysis will also assess the COVID-19 antibody responses between vaccinated and un-vaccinated participants.

Methods:

This randomized controlled clinical trial (RCT) with two parallel comparator groups of Arsenicum album 30CH (AA30CH) and placebo, having an allocation ratio of 1:1, was proposed in the Pathanamthitta district of Kerala, India. Based on the inclusion and exclusion criteria, 112 participants per arm (with an expected dropout of 20%) will be screened.

Results:

The current RCT protocol has been approved by various committees and funded by the Central Council for Research in Homoeopathy (CCRH), Ministry of Ayush, Government of India. The project has been implemented in collaboration with the Department of Homoeopathy, Government of Kerala. The RCT was rolled out on 25th January 2023, and the enrolment has been completed as of 3rd April 2023. The immunological assays will be conducted at DBT-THSTI, Faridabad, India.

Conclusions:

For the first time, this current study will evaluate the immunological efficacy and safety of AA30CH in an RCT and may significantly impact the evidence-based medicine approach in Homoeopathy. Clinical Trial: The trial has been prospectively registered in the Clinical Trial Registry - India (CTRI) with Registration No. CTRI/2022/08/045089 dated 30/08/2022.