JMIR Publications

ABSTRACT

Background:

Rhino-orbital-cerebral Mucormycosis (ROCM) is the commonest form (45–74%) of mucormycosis seen in India. With the availability of 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 COVID19 have been increasingly reported world-wide, from India, due to immune dysregulation caused by the Coronavirus. To reduce the high mortality rate and residual defect in most of the survivors under the guidelines of the Ministry of AYUSH, Govt. of India recommended Homoeopathy as an add-on therapy to maximize the effectiveness of the standard line of treatment in conventional therapy.

Objective:

The aim of this study is to evaluate the role of existing homoeopathic treatment as an adjuvant therapy in covid-related ROCM patients as well as enhancing the survival of the patients hospitalized due to Covid-19 and to access the initial treatment response and duration required for significant/complete recovery in patients of adjuvant treatment group as compared to control group.

Methods:

The randomized controlled clinical trial (RCT) will include two parallel comparator groups A and B. Group A will be the experimental group and will receive Homoeopathic treatment along with the standard line of treatment as per IMP and Group B will be the control arm and will receive standard line of treatment as per IMP along with identical placebo. Allocation will be 1:1 through randomization. Based on the inclusion and exclusion criteria, 36 participants per arm will be screened. Participants will be assessed clinically twice a day and MRI/Endoscopy cum-biopsy will be assessed on Day 1, 14 and 28, Laboratory investigations may vary as per demand of disease conditions.

Results:

Due to the rapid decline in covid cases, we couldn’t initiate the study though this protocol was approved by the scientific advisory and ethical committees. However, the expected outcome of the study was to validate the efficacy of homoeopathy in covid-related ROCM as an adjuvant therapy and for enhancing the survival time of the hospitalized patients. Along with this, the changes were planned to be assessed through standard imaging or other laboratory parameters for the same. We expect that if this study could have materialized, it could have shown the road ahead for such an integrated approach in ROCM cases, which usually have a limited scope in the treatment of any kind of modality.

Conclusions:

This study will be helpful in evaluating the role of existing homoeopathic medicines as an adjuvant therapy in the management of covid-related ROCM which may significantly impact the use of homoeopathy as an evidence-based medicine approach. Clinical Trial: The clinical trial registration was not done as the mucormycosis cases started declining. However, ethical clearance was granted to the study by the study site committee.