Comparative Evaluation of Effectiveness of Standard of Care Alone and in Combination With Homoeopathic Treatment in COVID-19–Related Rhino-Orbito-Cerebral Mucormycosis (ROCM): Protocol for a Single Blind, Randomized Controlled Trial
Bibliographic record
Abstract
BACKGROUND: Rhino-orbital-cerebral mucormycosis (ROCM) is the most common (45%-74%) mucormycosis in India. With contemporary medical care, ROCM has a mortality rate of 40%-50% and 70% of survivors are left with residual defects. Recently, several cases of mucormycosis in people with COVID-19 have been increasingly reported worldwide, from India, due to immune dysregulation caused by SARS-CoV-2. To reduce the high mortality rate and residual defect in most survivors under the guidelines of the Ministry of AYUSH, the Government of India recommended homoeopathy as an add-on therapy to maximize the effectiveness of standard treatment in conventional therapy. OBJECTIVE: This study aimed to evaluate the role of existing homoeopathic treatment as an adjuvant therapy in patients with COVID-19-related ROCM and enhancing the survival of the patients hospitalized due to COVID-19 infection and to access the initial treatment response and duration required for significant or complete recovery in patients receiving adjuvant treatment. METHODS: This superiority, randomized controlled clinical trial would include two parallel comparator groups A and B. Group A would be the experimental group and would receive homoeopathic treatment along with the standard line of treatment as per investigational medicinal product (IMP) and group B would be the control arm and would receive standard line of treatment as per IMP along with identical placebo. Allocation would be 1:1 through randomization. Based on the inclusion and exclusion criteria, 36 participants per arm would be screened. Participants would be assessed clinically twice a day and magnetic resonance imagery or endoscopy cum-biopsy would be assessed on days 1, 14, and 28. Laboratory investigations may vary as per demand of disease conditions. RESULTS: In India, the COVID-19 pandemic, particularly during the second wave, resulted in a surge of mucormycosis cases among patients with COVID-19. At the time this protocol was being developed, there was a significant spike in mucormycosis cases in India, particularly in Mumbai (June 2021). However, by the time the Central Council for Research in Homoeopathy obtained the necessary approvals and ethical clearance for the study, the incidence of mucormycosis had drastically declined (September 2021). As a result, the study was not initiated and registered. The authors feel it is their ethical responsibility to share the reviewed protocol with the medical community as a reference for future work. CONCLUSIONS: This study aims to evaluate the role of existing homoeopathic medicines as an adjuvant therapy in managing COVID-19-related ROCM, potentially contributing to the use of homoeopathy as an evidence-based medical approach. The protocol can also serve as a valuable resource for clinicians and researchers addressing mucormycosis cases unrelated to COVID-19, particularly in immunocompromised patients. It would help ensure preparedness, whether or not sufficient evidence is available, in the event of a future health emergency. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/57905.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.016 | 0.018 |
| Meta-epidemiology (narrow) | 0.005 | 0.002 |
| Meta-epidemiology (broad) | 0.012 | 0.006 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.002 | 0.003 |
| Scholarly communication | 0.003 | 0.003 |
| Open science | 0.003 | 0.001 |
| Research integrity | 0.006 | 0.005 |
| Insufficient payload (model declined to judge) | 0.030 | 0.003 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".