Dementia is a progressive impairment of cognitive functions occurring in clear consciousness (i.e.in the absence of delirium). It is an acquired persistent and progressive deterioration in cognitive abilities that impairs the successful performance of activities of daily living. Memory is the most common cognitive ability lost with dementia. Currently more than 55 million people have dementia worldwide, over 60% of whom live in low-and middle-income countries. Every year, there are nearly 10 million new cases. Dementia is the seventh leading cause of death and one of the major causes of disability and dependency among older people globally. In 2019, dementia cost economies globally 1.3 trillion US dollars, approximately 50% of these costs are attributable to care provided by informal carriers (e.g. family members and close friends), who provide on average 5 hours of care and supervision per day. 

Dementia is a complex and multifaceted condition which in today’s society continues to affect millions of individuals worldwide, with numbers expected to tripled by 2025. The impact of dementia extends far beyond the individual, causing emotional and psychological distress for families and caregivers, while also placing a significant burden on healthcare systems and economies. This disease significantly impairs cognitive function and daily living activities, leading to a marked decline in quality of life of affected individuals. Despite its prevalence, dementia remains poorly understood, with no cure or effective treatment available for most types. Additionally, the conventional treatment available currently, fall short in proving long term benefits and also come with side effects that may further complicate the care of the elderly patients. Given this context, exploring alternative or complimentary approaches such as Individualized Homoeopathic Medicines with a holistic approach may be advantageous in managing conditions like dementia by acting on the vital force which is the basis of homoeopathy. Therefore, research in dementia is essential for developing early detection methods, effective treatments, and supportive care strategies, ultimately improving the quality of life for those affected. By studying dementia, we can gain deeper understanding of its causes, risk factors, and progression, driving progress towards a future with improved outcomes and hope for those impacted by this debilitating condition. Available data reveals that up to 23% of patients qualify for the group of ‘potentially reversible’ dementias  and that includes medication related dementia, psychiatric disorders specifically depressive disorders (pseudo-dementia), surgical brain lesions , i.e. normal pressure hydrocephalus, tumours, chronic subdural haematoma, metabolic disorders such as hypothyroidism, hypo- parathyroid, vitamin B12 deficiency, CNS infections (like late stage of neuro-syphilis, HIV, etc). In an Indian report 18% cases of dementia were found to be because of (untreated/poorly treated) neuro-infections and B12 deficiency. It is very important to look for these conditions as further damage can be minimised with proper and timely intervention. The findings could potentially influence clinical practice, guide future research, and offer new therapeutic options for patients suffering from dementia, hence it leaves a scope for the study.

study design: Single blind randomized parallel arm experimental controlled study

study type: experimental 

study setting: Patients will be recruited from OPD of the Research Centre

study population: Geriatric patients with Pre-diagnosed cases of Dementia as per 6CIT with a score below

inclusion criteria: 1 Cases belonging to all genders 2 Cases of age group above 65 years 3 Cases undergoing regular allopathic treatment for dementia 4 Cases with or without co-morbidities will be included

exclusion criteria: 1 Cases suffering from other Psychiatric illness 2 Cases suffering from Dementia due to head injury 3 Cases that are physically disabled 4 Cases that are Mentally retarded 5 Cases who are suffering from carcinoma 6 Cases of CKD who are on dialysis 7 Cases undergoing treatment other than Allopathic treatment

subject withdrawal criteria: 1 Cases not willing to continue the trial and want to withdraw the consent 2 Cases that do not follow up regularly 3 Cases requiring emergency medical or surgical intervention

sampling teachnique: Non Probability Deliberate sampling

data collection method: 1 Patients will be identified and pre diagnosed as per 6CIT scale 2 Written informed consent will be taken 3 The detailed homoeopathic case taking will be carried out on standard case proforma 4 Totality of symptoms will be formed and indicated homoeopathic medicine will be prescribed on the basis of Individualisation 5 Susceptibility will be assessed and appropriate posology will be 6 selected on the basis of assessment 7 MoCA scale will be ap plied at baseline, 6 and 12 8 DemQOL scale will be applied at baseline, 6 and 12

data analysis method: Data collected will be compiled on to a MS Office excel worksheet & will be subjected to statistical analysis using an appropriate package like SPSS software. Descriptive statistics like frequency (n) & percentage (%) of categorical data, mean & Standard deviation of numerical data in time interval will be depicted. Frequency (n) & percentage (%) of various categories in each time interval will be compared using chi square test / McNemar’s test. Intra group comparisons for a numerical continuous data following a normal distribution will be done using paired t test (for 2 observations) or repeated measures ANOVA for >2 observations, else a non-parametric substitute like Wilcoxon signed rank test (for 2 observations) or Friedman’s test for >2 observations will be used. Keeping alpha error at 5% and Beta error at 20%, power at 80%, p<0.05 will be considered statistically significant. Independent sample t-test for comparing continuous variables (like age, baseline cognitive scores) between the treatment and control groups Chi-square test for comparing categorical variables (like gender distribution, presence of comorbid conditions) between the treatment and control groups Repeated measures ANOVA for primary outcome measure to compare the changes in cognitive scores over time between the treatment and control groups accounting for within subjective correlations ANCOVA for secondary outcome measure to compare post treatment cognitive scores between treatment and control groups, adjusting for baseline scares and other covariates Paired t-test or Wilcoxon Signed-rank Test for within-group comparisons of pre and post treatment scores, depending on whether the data is normally distributed Fisher’s exact test to compare the proportion of responders who show a clinically significant improvement between the treatment and control groups

mechanism to assure the quality of study :The medicine from the sealed bottle from the same batch and from a good manufacturing practice (GMP) certified standard pharmacy will be administered orally

ethical consideration: ethical clearance obtained from ethics committee