Immunological Responses of Arsenicum album 30CH to Combat COVID-19: Protocol for a Double-Blind, Randomized, Placebo-Controlled Clinical Trial in the Pathanamthitta District of Kerala
Notice bibliographique
Résumé
BACKGROUND: COVID-19 is a recent major public health concern caused by the SARS-CoV-2 virus, with approximately 44.6 million COVID-19-positive cases and 530,000 deaths in India (as of February 1, 2023). The COVID-19 vaccination drive in India was initiated in January 2021; however, an effective preventive strategy with high efficacy and immunological safety remains elusive. OBJECTIVE: The aim of this study is to assess the immunogenic responses of Arsenicum album 30CH (AA30CH) as COVID-19 prophylaxis, including assessment of immunological markers, innate and acquired immune responses, COVID-19 symptoms, and its associated antibody responses. METHODS: This randomized controlled clinical trial (RCT) will include two parallel comparator groups of AA30CH and placebo with an allocation ratio of 1:1 conducted in the Pathanamthitta district of Kerala, India. The placebo or AA30CH will be administered in three intervention schedules and blood samples will be collected before and after each of the intervention schedules. Based on the inclusion and exclusion criteria, 112 participants per arm (with an expected dropout of 20%) will be screened. Immunogenic responses will be evaluated by determining the antigen density and modulation in immunological markers and lymphocyte subsets CD3, CD4, CD8, CD24, CD27, CD38, CD4 interferon-γ, CD4 CD17, CD4 CD25 (activated T lymphocytes), T cells, B cells, dendritic cells (mature and immature), and natural killer cells on days 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 (RT-PCR) array profiler (84-gene set) before and after the study interventions. The toxicity status of AA30CH in study participants will be evaluated through hepatic, renal, and hematological parameters and peripheral smears on days 1, 5, 23, 27, 45, 49, and 66. The number of participants developing COVID-19-like symptoms per National Centre for Disease Control 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 subgroup analysis will be used to assess the COVID-19 antibody responses between vaccinated and unvaccinated participants. RESULTS: This RCT protocol has been approved by various committees and funded by the Central Council for Research in Homoeopathy, 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 January 25, 2023, and enrollment was completed April 3, 2023. The immunological assays will be conducted at the Department of Biotechnology-Translational Health Science and Technology Institute, Faridabad, India. CONCLUSIONS: This study will represent the first evaluation of the immunological efficacy and safety of AA30CH in an RCT, which may significantly impact the use of homeopathy as an evidence-based medicine approach. TRIAL REGISTRATION: Clinical Trials Registry-India CTRI/2022/08/045089; https://tinyurl.com/mryrpkvk. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/48479.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,016 | 0,013 |
| Méta-épidémiologie (sens strict) | 0,006 | 0,003 |
| Méta-épidémiologie (sens large) | 0,011 | 0,004 |
| Bibliométrie | 0,002 | 0,002 |
| Études des sciences et des technologies | 0,003 | 0,004 |
| Communication savante | 0,003 | 0,003 |
| Science ouverte | 0,003 | 0,002 |
| Intégrité de la recherche | 0,007 | 0,007 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,037 | 0,007 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».