| Depression is a major global mental health concern, affecting over 300 million people worldwide, and is a leading cause of disability and disease burden. Despite the availability of effective treatments, over 75% of individuals in low- and middle-income countries remain untreated due to factors like stigma, lack of awareness, and inadequate mental health infrastructure. Mild depression, though often overlooked, can significantly impair an individual’s emotional and functional well-being. The COVID-19 pandemic has further intensified the prevalence of depression due to psychosocial stressors like isolation, fear, and financial instability. In developing countries like India, societal stigma often deters people from acknowledging or seeking help for mental health issues. Many families turn to homoeopathy as a safe, natural, and holistic alternative, believing in its potential for long-term cure without side effects. Homoeopathy views depression not just as a symptom-based illness but as a reflection of an individual’s overall imbalance in vital force. By focusing on individualized treatment and addressing both mental and physical aspects of the patient, homoeopathy aims to restore emotional harmony and overall health. This study aims to evaluate the effectiveness of individualized homoeopathic medicines in managing mild depression using a placebo-controlled experimental design. The research is expected to provide evidence-based insight into the role of homoeopathy in mental health care, especially in resource-constrained settings. EPIDEMIOLOGY Prevalences. An estimated 3.8% of the population experience depression, including 5% of adults (4% among men and 6% among women), and 5.7% of adults older than 60 years. Depression is about 50% more common among women than among men. Worldwide, more than 10% of pregnant women and women who have just given birth experience depression Geographical Variation: Prevalence often reported in high-income countries. Europe and North America often report higher prevalence rates of depression compared to other continents. North America. High prevalence rates of depression, with the United States reporting around 7.1% of adults experiencing major depression. Continent estimated prevalence of depression (1)-Africa4.4%, Asia4.2%,Europe5.2%,NorthAmerica5.1%,South America5.0%,Australia/Oceania5.9% The prevalence of depression varies Asian countries. (1) China 4.2%, India 4.5%, Japan 3.1%, South Korea 6.7%, Indonesia 3.7%, Pakistan 4.2%, Philippines 3.3%, Vietnam 2.8%, Malaysia 3.9%, Thailand 3.2%, Age-wise distribution of the prevalence of depression (1) Typically observed in population studies :Age group estimated prevalence of depression Children (6-12)2-3%Adolescents (13-18)11-12%Young Adults (18-25)13-15%Adults (26-49)7-10%Older Adults (50-64)6-7%Seniors (65+)3-5% Clinical features and sign and symptoms 1. Depressed mood almost every day for most of the day. 2 Markedly reduced interest or pleasure in all, or almost all activities almost every day for most of the day. 3 Significant wt. loss or wt. gain when not dieting, or increased or decreased appetite almost every day. 4. Insomnia or hypersomnia almost every day. 5 Agitation or retardation almost every day. 6. Fatigue or loss of energy almost every day. 7 Feelings of worthlessness or excessive or Inappropriate guilt almost every day. 8 Reduced ability to think or concentrate Or Indecisiveness almost every day. 9 Recurrent thoughts of death or suicide 10 No delusions or hallucinations in absence of mood symptoms for as long as 2 weeks during the course of the illness. 11 Not superimposed on schizophrenia or other psychoses. A)INCLUSION CRITERIA 1) The patient having PHQ-9 Score: 5-9 indicates mild depression. 2) Adults aged above 18 yrs.(24) 3) All the genders. 4) All socioeconomic status. B) EXCLUSION CRITERIA: I) Patient suffering from or history of other psychiatric illness. II) Pregnancy or lactating womans. III) Patient having any co-morbidity. IV) Patient taking other mode of treatment. V)Patient with suspected immunocompromised disease and medical and surgical emergencies . C) SUBJECT WITHDRAWAL CRITERIA- I) Development of moderate to severe depression during the study. II) If any medical or surgical emergency arises. III) Non-compliance with study procedures. IV) Withdrawal of consent by the participant. V) Patient required medical and surgical interventions. Study design A single -blind randomized placebo -controlled experimental study Study setting Cases from institute OPD. Study population Diagnosed Cases of mild- depression by psychiatrist from institute OPD. Sampling technique Simple random sampling technique. Participant will be divided in to two groups using computer generated sequences. Trial group (T group) and control group (C group).Every even case shall go in group T and every odd case shall go in group C. Statistical analysis: 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 each group / subgroup will be depicted. Frequency (n) & percentage (%) of various categories in each group / subgroup will be compared using chi square test. Normality of numerical data will be checked using Shapiro Wilk test or Kolmogorov-Smirnov test. Depending on the normality of data, statistical tests will be determined. For a numerical continuous data following a normal distribution, inter group comparison (2 groups) will be done using t test, else a non parametric substitute like Mann Whitney U test will be used. 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 Friedmans test for >2 observations will be used. Frequency (n) & percentage (%) of various responses in each time interval will be compared using chi square test / McNemars test. Keeping alpha error at 5% and Beta error at 20%, power at 80%, p<0.05 will be considered statistically significant. DATA COLLECTION METHODS Self-reported questionnaires -Patient health questionnaire (PHQ) Clinical interviews- A detailed case taking according to the case report format and clinical examination will be done. Before participation in the study, a patient information sheet written in local vernacular marathi will be provided to all patients/parents and written consent will be taken from each. Data collection instrument Data Collection tools 1. Patient health questionnaire (PHQ-9) 2. Written Informed Consent will be taken and also approved by IEC. 3. Standardized Case Record. 4. Medical certificate given by psychiatrist indicating diagnosis as a mild- depression . mechanism to assure the quality of the study The study quality will be assured by: Self check, self monitoring and standard tools will be used and written procedure by the primary researcher and the other team including lab technician and laboratory staffs will be done. 2. The selection bias will be minimized by a random allocation through computer generated sequences. 3. Blood investigation will be done by standard authentic laboratory . 4. Transparent project planning documentation, processing and analysis of the data: we documented data and usage of the standardized case record. 5. Data will be stored in physical as well as electronic forms in more than one device to assure the safety of storage of records.6.Placebo group safety: They can take symptomatic treatment during the research study. Eg. They can consult psychiatrist /psychologist if sleeplessness suffering , or any exagarreted mental symptoms .Particent can take medicine for acute illness.
ethical consideration - Ethical Consent from Institutional Ethical Committee has been obtained |