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CTRI Number  CTRI/2025/02/080264 [Registered on: 10/02/2025] Trial Registered Prospectively
Last Modified On: 07/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Understanding And Managing Depression In Old Age With Homoeopathy 
Scientific Title of Study   Study On The Major Depressive Disorder In Geriatric Age And Its Homoeopathic Management 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Janki Rajeshbhai Vank  
Designation  MD Scholar Part-2 
Affiliation  C D Pachchigar College of Homoeopathic Medicine and Hospital 
Address  Department Of Psychiatry Division Of MD 2nd Floor C D Pachchigar College of Homoeopathic Medicine And Hospital Surat Gujarat Near Anand Mangal Road Surat Gujarat

Surat
GUJARAT
395001
India 
Phone  926530907  
Fax    
Email  vankjanki22@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arun Bhatia 
Designation  Assistant Professor 
Affiliation  C D Pachchigar College of Homoeopathic Medicine And Hospital 
Address  Department Of Psychiatry Division Of MD 2nd Floor C D Pachchigar College of Homoeopathic Medicine And Hospital Surat Gujarat Near Anand Mangal Road Surat Gujarat

Surat
GUJARAT
395001
India 
Phone  9033111464  
Fax    
Email  sunstarhc2012@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Arun Bhatia 
Designation  Assistant Professor 
Affiliation  C D Pachchigar College of homoeopathic Medicine And Hospital 
Address  Department Of Psychiatry Division Of MD 2nd Floor C D Pachchigar College of Homoeopathic Medicine And Hospital Surat Gujarat Near Anand Mangal Road Surat Gujarat

Surat
GUJARAT
395001
India 
Phone  9033111464  
Fax    
Email  sunstarhc2012@gmail.com  
 
Source of Monetary or Material Support  
C D Pachchigar College of Homoeopathic Medicine And Hospital Near Anand Mangal Society Udhana Magdalla Road Surat 395001 Gujarat India 
 
Primary Sponsor  
Name  C D Pachchigar college of homoeopathic Medicine and Hospital 
Address  C D Pachchigar College of Homoeopathic Medicine And Hospital Near Anand Mangal Society Udhana Magdalla Road Surat 395001 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Janki Rajeshai Vank  C. D. Pachchigar college of homoeopathic medicine and hospital  Department Of Psychiatry Division Of MD 2nd Floor C D Pachchigar college of homoeopathic medicine and hospital, near anand mangal society, Udhana Magdalla road, Surat
Surat
GUJARAT 
9265370907

vankjanki22@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee of C D Pachchigar College of Homoeopathic Medicine and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F30-F39||Mood [affective] disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic Medicine  Homoeopathic Medicine dose potency and repetition as per the requirement of the case through Oral mode of administration within time duration of 9 months 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients of all economic classes
Patients fulfilling the diagnostic criteria of Major Depressive Disorder according to the DSM-5. 
 
ExclusionCriteria 
Details  Age below 60 years
Patients with neurocognitive disorders
Patients already taking antidepressants 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To understand role of Homoeopathy on the Major Depressive Disorder in Geriatric Age Group   6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To identify risk factors influencing Major Depressive Disorder in Geriatric Age Group  6 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   18/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

6

BRIEF RESUME OF INTENDED WORK:

6.1

NEED FOR STUDY:

In India, there is a sustained rise in the elderly population, with 8.6% aged 60 years and older, according to the 2011 Census data. (1)

 

The prevalence of Major Depressive Disorder (MDD) in older adults is a critical concern due to its high incidence and associated risks. Overall, MDD carries a lifetime risk of 8.2 to 10.6 percent in older adults, surpassing the risks associated with other mood disorders. (2)A study by Baura et al. reported a median prevalence rate of 21.9% for depression among the elderly Indian population. (3)

 

Ageing is often accompanied by losses in physical capability, socio-economic conditions, and social life. Factors such as living arrangements, marital status, literacy, and morbidity have been identified as significant contributors to depressive mood and depression in older adults.

 

Additional studies by Reddy et al. identified various risk factors, including female gender, poverty, illiteracy, loneliness, widowhood, and dependency, highlighting the multifactorial nature of geriatric depression. (4) Studies conducted by Pilania et al. and Sengupta et al. identified specific risk factors in the Indian context, such as female gender, chronic morbidity, illiteracy, nuclear families, living alone, poverty, death of close relatives, and not working, etc. (5) (6) Understanding these factors is crucial for developing targeted interventions and support systems.

 

Depression often goes undiagnosed in older adults due to denial, stigma, and the misattribution of symptoms to normal aging or physical illnesses. Co-morbidity with physical illness and other mental disorders further complicates the diagnostic, preventive, and treatment aspects for healthcare professionals.

 

Due to age-related changes in organ functioning, the geriatric population demonstrates reduced tolerance to medications and is at a greater risk of side effects (2) which highlights the suitability of homoeopathy for geriatric age, given its none or minimal side effects. Homoeopathy emphasizes individualization, addressing the unique picture of each patient as a whole.

 


 

 

6.2

 

REVIEW OF LITERATURE:

 

INTRODUCTION

 

Depressive disorders are characterized by a depressive mood (e.g., sad, irritable, empty) or loss of pleasure accompanied by other cognitive, behavioral, or neurovegetative symptoms that significantly affect the individual’s ability to function. (7) Depressive disorders can take many forms, depending on their severity and chronicity. The disorder mostly associated with “classic” depression is major depressive disorder, and this is the disorder most often referred to when someone reports that they suffer from depression.

 

Major depressive disorder (MDD) (unipolar depression) is reported to be the most common mood disorder. It may manifest as a single episode or as recurrent episodes. Major Depressive Disorder has been ranked as the third cause of the burden of disease worldwide in 2008 by the WHO, which has projected that this disease will rank first by 2030. (8)

 

The main feature of major depressive disorder is the occurrence of at least one episode of major depression, which is significant depressive symptoms that last for a significant period of time.

 

DIAGNOSTIC CRITERIA

According to DSM-5, diagnostic criteria of Major depressive disorder are as following (9):

 

A. Five or more of the following symptoms that have been present during the same 2- week period and represent a change from previous functioning; at least one of the symptoms is either (1) depressed mood or (2) loss of interest or pleasure

1. Depressed mood

2. Markedly diminished interest or pleasure in all or almost all activities

3. Significant weight loss or weight gain

4. Insomnia or hypersomnia

5. Psychomotor agitation or retardation

6. Fatigue or loss of energy

7. Feeling of worthlessness or excessive or inappropriate guilt

8. Diminished ability to think or concentrate, or indecisiveness

9. Recurrent thoughts of death, recurrent suicidal ideation

 

B. Symptoms cause clinically significant distress or impairment in social, occupational, or other areas of functioning.

 

C. The episode is not attributable to the physiological effects of a substance or another medical condition.

 

 

D. At least one major depressive episode is not better explained by schizoaffective disorder and is not superimposed on schizophrenia, schizophreniform disorder, delusional disorder, or other specified and unspecified schizophrenia spectrum and other psychotic disorders.

 

E. There has never been a manic episode or hypomanic episode.

 

Major depressive disorder may be present with psychotic features, melancholic features, atypical features, catatonic features and seasonal pattern. (10)

 

RISK AND PROGNOSTIC FACTORS

 

Temperamental

Environmental

Genetic and physiological

Course modifiers (9)

 

RATING SCALES FOR DEPRESSION (2) (10)

 

Clinician administered scale- the Hamilton Rating Scale for depression (HRSD) and Montgomery-Asberg Depression Scale (MADRS) particularly useful in patients with melancholic depression.

 

Self administered scale-The Zung self-Rating Depression Scale, The Beck depression scale, Geriatric depression scale (GDS), The Raskin Depression Scale, Center for Epidemiological Studies- Depression Scale (CES-D)

 

COMORBIDITY

 

Major depressive disorder frequently co-occurs with substance-related disorders, panic disorder, GAD (generalized anxiety disorder), PTSD (post traumatic stress disorder), OCD (obsessive compulsive disorder), anorexia nervosa, bulimia nervosa and borderline personality disorder. (9)

 

DIFFERENTIAL DIAGNOSIS(9)(10)

 

Manic episodes with irritable mood or mixed features

Bipolar disorders

Depressive disorder due to another medical condition

Substance/ medication induced depressive disorder

Persistent depressive disorder

Premenstrual dysphoric disorder

Disruptive mood dysregulation disorder

Schizophrenia

Attention-deficit hyperactivity disorder

Adjustment disorder

Bereavement

Sadness

Dementia

Parkinson disease

 

MAJOR DEPRESSIVE DISORDER IN GERIATRIC AGE:

 

In India, elderly or senior citizens have been defined in the National Policy for Older person 1999 as people with an age more than 60 years. (1)

Depressive symptoms are present in about 15 percent of all community residents and nursing home patients. (10) Older people are particularly vulnerable to major depressive episodes with melancholic features.

Major depression manifests somewhat differently in older compared to younger adults. Physical symptoms such as changes in appetite and body weight, constipation, and sexual dysfunction are more common in older adults; on the other hand, the physical symptoms in older adults could be a result of an undiagnosed physical illness. Depressive symptoms are common among older adults and are associated with functional impairment and decline, mortality, increased service utilization, and decreased quality of life.

 

Risk factors and correlates of depression in late life:

 

Being widowed or otherwise unmarried, impaired functional status, impaired social support, perceived loneliness, perceived poorer health, low internal locus of control, family history of depression, fewer years of education, living in an urban area, lower socioeconomic status, having one or more chronic physical illnesses, experiencing other recent stressful events. (2)

 

Psychological aspect: (11)

 

Old age carries special risks, not the least of which is poverty and fixed income. In addition, the aging body is highly vulnerable to disease. In the elderly, bleak circumstances and the internal state that Erikson referred to as despair can combine to make life seem not worth living and can produce psychological disturbances, including depression severe enough to provoke suicide. This happens especially to elderly people who are enfeebled and dependent at home or on nursing facilities that give little reinforcement for responsive, adaptive behavior.

 

 

HOMOEOPATHIC APPROACH

 

As per Dr. Hahnemann, mental diseases are one-sided diseases of chronic type affecting the whole psychosomatic entity, which manifest most of the symptoms on the mental aspect of the human organism. (Aphorism 210) (12)

Some of the homoeopathic medicines that are important for themanagement of depression from the homoeopathic repertory by William Boericke under mind, mood, disposition, melancholic, despondent, depressed, low spirited, gloomy, apprehensive, “blues” are Anacardium, Arsenic, Aurum met, Cimicifuga, Conium, Cyclamen,  Ignatia, Natrum Mur, Platina, Sepia, Staphysagria etc. (13)

 

6.3

 

OBJECTIVE OF THE STUDY:

To understand role of Homoeopathy on the major depressive disorder in geriatric age group.

To identify risk factors influencing Major Depressive disorder in Geriatric age group.

To reduce repeated attack and relapses in Major depressive disorder among the geriatric population.

 


7.1

SOURCES OF DATA:

OPD and IPD of C.D. Pachchigar General Hospital, Near navjivan circle, Udhana-magdalla road, Surat-395001

Peripheral OPD and regular camp visit of C. D. Pachchigar General Hospital

 

7.2

MATERIALS:

Case proforma of C. D. Pachchigar General Hospital

Textbook of Psychiatry and Geriatric Psychiatry, Psychology, book of Organon of Medicine, Materia Medica, Repertory, All homoeopathic books and literature related to the topic, Software & soft or hard research material.

Consent form of the patients.

 

7.3

METHOD OF COLLECTION OF DATA:

1. Study design - Experimental study.

2. Study type - Prospective study.

3. Study population - Patients from OPD of C. D. Pachchigar General Hospital and from Peripheral OPD fulfilling the inclusion criteria.

4. Sample size - 30 cases.

5. Sampling techniques - Simple random sampling.

6. Study duration - 9 months.

7. Selection criteria.

Inclusion criteria

 

Age: above 60 years

Sex: both sexes

Patients of all economic classes

Patients fulfilling the diagnostic criteria of Major Depressive Disorder according to the DSM-5.

 

 

Exclusion criteria

 

Age: below 60years

Patients with neurocognitive disorders

Patients already taking antidepressants

 

Data analysis and methods:

 

Improved: Patients showing clinically significant decrease in intensity and severity of disease and less recurrence of disease episodes during the study period. Geriatric patients with improved scores in their respective scoring scales.

Not improved: No clinically favorable improvement after homoeopathic medicinal interventions. Geriatric patients with maintained or aggravated score in their respective scoring scales.

Left the treatment: Patients who will not maintain regular follow-up or leave the treatment in between the study period.

 

7.4

DOES THE STUDY REQUIRING ANY INVESTIGATION TO BE CONDUCTED ON PATIENTS OR OTHER HUMANS OR ANIMALS?

As per requirement of the case

7.5

 

HAS ETHICAL CLEARENCE BEEN OBTAINED FROM YOUR INSTITUTE?

 

YES


8

BIBILIOGRAPHY:

1.

Jain R, Malik C, Khanna S, Jain Y. Geriatric population in India: Demography, vulnerabilities, and healthcare challenges. Journal of Family Medicine and Primary Care. 2021; 10(1): 72.

2.

Sadock BJ, Sadock VA, Ruiz P. Kaplan & Sadock’s comprehensive textbook of psychiatry. 10th ed. Philadelphia: Wolten Kluwer; 2017.

3.

Barua A, Ghosh MK, Kar N, Basilio MA. Prevalence of depressive disorders in the elderly. Annals of Saudi Medicine. 2011 Nov; 31(6).

4.

Reddy N, Pallavi M, Reddy N, Reddy C, Singh R, Pirabu R. Psychological morbidity status among the rural geriatric population of Tamil Nadu, India: A cross-sectional study. Indian Journal of Psychological Medicine. 2012; 34(3): 227.

5.

Pilania M, Bairwa M, Khurana H, Kumar N. Prevalence and predictors of depression in community-dwelling elderly in rural Haryana, India. Indian Journal of Community Medicine. 2017; 42(1): 13.

6.

Sengupta P, Benjamin A. Prevalence of depression and associated risk factors among the elderly in urban and rural field practice areas of a tertiary care institution in Ludhiana. Indian Journal of Public Health. 2015; 59(1): 3.

7.

Organization WH. WHO. [Online].; 2022. Available from: https://icd.who.int/browse11/l-m/en.

8.

Bains N, Abdijadid S. Pubmed. [Online].; 2023. Available from: https://www.ncbi.nlm.nih.gov/books/NBK559078/.

9.

Association AP. Diagnostic and statistical manual of mental disorders. 5th ed.: American Psychiatric Association; 2022.

10.

Boland RJ, Verduin ML, Ruiz P. Kaplan & Sadock’s synopsis of psychiatry. 12th ed. Philadelphia: Wolters Kluwer; 2021.

11.

Morgan CT, King RA, Weisz JR, Schopler J. Introduction to Psychology. 7th ed. New Delhi: McGraw Hill Education (India) Private Limited; 2017.

12.

Hahnemann S, Boericke W. Organon of medicine New Delhi: B. Jain; 2016.

13.

Boericke W. Boericke’s new manual of homoeopathic materia medica with repertory : including Indian drugs, nosodes, uncommon rare remedies, mother tinctures, relationships, sides of the body, drug affinities, & list of abbreviations New Delhi: B. Jain Publishers; 2007.

 

 

 

 
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