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CTRI Number  CTRI/2025/01/079303 [Registered on: 23/01/2025] Trial Registered Prospectively
Last Modified On: 21/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Study On Development Of Depression In Working Adults And Its Homoeopathic Management 
Scientific Title of Study   Study On The Development Of Depressive Disorders In Employed Adults 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  Shobhana Nagjibhai Vala 
Designation  MD Scholar Part-2 
Affiliation  C D Pachchigar College Of Homoeopathic Medicine And Hospital 
Address  C D Pachchigar College Of Homoeopathic Medicine And Hospital Near Anand Mangal Road Surat

Surat
GUJARAT
395001
India 
Phone  9016543343  
Fax    
Email  shobhanavala44@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deepti Yesade 
Designation  Professor of Homoeopathy Psychiatry 
Affiliation  C D Pachchigar College of Homoeopathic Medicine And Hospital 
Address  C D Pachchigar College of Homoeopathic Medicine And Hospital Near Anand Mangal Road Surat

Surat
GUJARAT
395001
India 
Phone  9403803599  
Fax    
Email  deepti.yesade81@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Deepti Yesade 
Designation  Professor of Homoeopathy Psychiatry 
Affiliation  C D Pachchigar College of Homoeopathic Medicine And Hospital 
Address  C D Pachchigar College of Homoeopathic Medicine And Hospital Near Anand Mangal Road Surat

Surat
GUJARAT
395001
India 
Phone  9403803599  
Fax    
Email  deepti.yesade81@gmail.com  
 
Source of Monetary or Material Support  
C D Pachchigar college of Homeopathic Medicine And Hospital Near Anand Mangal Society Udhana Magdalla Road Surat 395001 Gujrat India 
 
Primary Sponsor  
Name  C D Pachchigar college of Homeopathic Medicine And Hospital 
Address  C D Pachchigar college of Homoeopathic Medicine And Hospital Near Anand Mangal Society Udhana Magdalla Road Surat 395001 Gujrat India 
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 
Shobhana Vala  C D Pachchigar College Of Homeopathic Medicine And Hospital  Department Of Psychiatry, Division Of MD, 2nd Floor C D Pachchigar College Of Homoeopathic Medicine And Hospital Surat Gujrat
Surat
GUJARAT 
9016543343

shobhanavala44@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee of C D Pachchigar 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  not applicable  not applicable 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details   Patient covering DSM-5 criteria for depressive disorder
 Adults who is employed 
 
ExclusionCriteria 
Details   Patient already on antidepressants.
 Patients with known case of serious medical illness, co-morbidity.
 Patients having depression due to any neurological, endocrinological, metabolic, medication and substance related disorders
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Homoeopathic Medicine Has No effect On Depressive Disorders of Employed Adults  6 Months 
 
Secondary Outcome  
Outcome  TimePoints 
Homoeopathic Medicine Has effect On Depressive Disorders of Employed Adults  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   N/A 
Date of First Enrollment (India)   03/02/2025 
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:

Depressive disorder is most common psychiatry illness and leading cause of disability world wise. More than half the world’s population are currently in work and 15% of working age adults live with a mental disorder. (1)

Work stress appears to precipitate diagnosable depression and anxiety in previously-healthy young workers. Helping workers cope with work stress or reducing work stress levels could prevent the occurrence of clinically-significant depression and anxiety. (2)

Assessing the extent of depressive disorders among employed adults  directly impacts workplace productivity, absenteeism, and overall job performance (3) and this study aims to identify employment- related risk factors precipitates depressive disorders, such as work related stress and job satisfaction and it helps in prevention of depression and intervention.

Homoeopathy is based on the principle “like cures like,” also known as Law of Similars. (4)Homoeopathy places a strong emphasis on individualization in treatment, aiming to identify the characteristics of each person’s symptoms rather than solely focusing on symptom management. The approach seeks to understand and address the underlying causes of symptoms, aligning with a holistic perspective of treatment. Exploring the effectiveness of homoeopathic management in treatment of depression, ultimately benefiting the homoeopathic fraternity.

6.2

REVIEW OF LITRATURE:

INTRODUCTION

Depression is characterized by persistent sadness and a lack of interest or pleasure in previously rewarding or enjoyable activities. (5)

Globally, the total number of people with depression was estimated to exceed 300 million in 2015, equivalent to 4.3% of the world’s population. (1)

The National Mental Health Survey of India (NMHS), 2015-16 has reported that India is home to an estimated 57 million people suffering from depression which is 18% of the global estimate. Nearly 15% Indian adults need active intervention for one or more mental health issues and one in 20 Indians suffers from depression. (6)

There are more prevalence of depression in people younger than 45 years of age. (7)

CLINICAL PRESENTATION :

A depressed mood and a loss of interest or pleasure are the key symptoms of depression. Patients may say that they feel blue, hopeless, in the dumps, or worthless.

The most typical somatic symptoms of depression are called the neurovegetative symptoms of depression and typically include a variety of physical symptoms. Decreased energy, tiredness, and fatigue are common.

Many individuals report impaired ability to think, concentrate, or make even minor decisions. (8) They may appear easily distracted or complain of memory difficulties. Thoughts of death, suicidal ideation, or suicide attempts  are common. Psychomotor agitation may occur, including such behaviours as hand wringing and hair pulling. Many depressed patients have a decreased rate and volume of speech; they respond to questions with single words and exhibit delayed responses to questions. (8)

TYPES OF DEPRESSIVE DISORDERS:

·       Major Depressive Disorder:

The primary features of major depressive disorder is the occurrence of at least one episode of major depression, which is significant depressive symptoms that last for significant time (>2weeks)   Diagnostic criteria of MDD is given in DSM-5.

Common Symptoms of major depressive disorder  is following (8)       

-       Dysphoria or feeling depressed

-       Anhedonia

-       Increased or decreased weight or appetite

-       Increase or decrease sleep

-       Increase or decrease activity

-       Decreased energy

-       Depressing thoughts: worthlessness, guilt

-       Decreased concentration

-       Suicidal ideation/plan

Major depressive disorder may presented with psychotic symptoms, with melancholic symptoms, with Atypical features with catatonic features.

·       Dysthymic disorder:

Dysthymia is not severe than a major depressive disorder, it is often more chronic. The most typical feature of dysthymia, also known as persistent depressive disorder, is the presence of a depressed mood that lasts most of the day and is present almost continuously. There are associated feelings of inadequacy, guilt, irritability, and anger; withdrawal from society; loss of interest; and inactivity and lack of productivity.

Other Diagnoses:

·       Minor Depressive Disorder. Minor depressive disorder consists of episodes of depressive symptoms that are less severe than those seen in major depressive disorder. The difference between dysthymia and minor depressive disorder is primarily the episodic nature of the symptoms in the latter.

·       Recurrent Brief Depressive Disorder: Recurrent brief depressive disorder consists of brief periods (less than 2 weeks) during which depressive episodes are present.

·       Double Depression: An estimated 40% of patients with major depressive disorder also meet the criteria for dysthymia, a combination often referred to as a double depression.

o   Neurotransmitter Deficits Are Involved. (5)

Norepinephrine

Serotonin

Dopamine

Acetylcholine

Stress is usually defined as a state of disturbed homeostasis inducing somatic and mental adaptive reactions, globally defined as “stress response,” aiming to reconstitute the initial homeostasis or a new level of homeostasis after successful adaptation, i.e., allostasis. There is wide consensus and support from preclinical and clinical data that stress exposure conceivably plays a causal role in the etiology of MD and depression-like disorders. (9)

o   Objective Rating Scales for Depression:

Clinician Administered Scales: The Hamilton Rating Scale

Self-Administered Scales: The Zung Self-Rating Depression Scale.

DIFFERENTIAL DIAGNOSIS

Schizophrenia

Manic episode with irritable mood or mixed features

Uncomplicated bereavement

Bipolar disorder

Substance use disorder

THE PSYCHOLOGY OF DEPRESSION

Stress and Depression : Some clinicians believe that life events play the primary or principal role in depression; others suggest that life events have only a limited role in the onset and timing of depression. (5)

If stressors are maintained, long-term emotional effect occur which leads to emotional disorders like chronic depression and anxiety, phobias, personality changes, and other mental illness which causes decreased productivity, decreased enjoyment and decreased intimacy. (10)

Relationship between stress and depression is to focus not on specific life events, per se, but rather on the effects of chronic stress. Studies in this genre are few, but those that do exist tend to support a relationship between chronic stress and the propensity for major depression. (10)

HOMOEOPATHIC APPROACH

Mental diseases of Psychosomatic type (§225): Mental diseases that arise as a result of prolonged emotional disturbances and different psychological depressions like continued anxiety, worry, vexation, wrongs and frequent occurrence of greater fear and fright. Such diseases may be of recent origin and may not have developed fully into corporeal diseases. But if left untreated they may damage the body. (4)

According to aphorism 215-216 Hahnemann considers mental disease as one sided diseases of the chronic type affecting the whole psychosomatic entity.

Common suitable homeopathic drugs for depression: (11)

Avena sativa

Causticum

Cimicifuga racemosa

Ignatia

Kali phosphoricum

Natrum muriaticum

Pulsatilla

Sepia

Aurum metallicum

6.3

OBJECTIVES OF STUDY

1. To identify stressors precipitates development of depression in employed adults.

2. To access the effect of homoeopathic management in treatment of depressive disorder in adults with work stressors.

3. To reduce recurrent attack and relapses.

 

 


 

7

MATERIALS AND METHODS

7.1

SOURCE OF DATA

·       O.P.D of C.D. PACHCHIGAR Homoeopathic college & hospital.

·       Peripheral centre, and regular camp visit of C.D. PACHCHIGAR Homeopathic medical college & hospital.

·       Data will be collected via interview processes, this process includes guidelines mentioned in the organon of medicine, and case-taking will be done with reference to aphorisms number 83 to 104 as explained by Dr. Sammuel Hahnemann.

7.2

MATERIAL:

Textbooks of Psychiatry, Book of organon of medicine, philosophy, Materia medica, repertory, all homoeopathic books & literature related to topic, software & soft or hard research material.

7.3

METHOD OF COLLECTION OF DATA:

1. Study type: Experimental study

2. Study design: Prospective study

3. Study population: patients from OPD of C. D. Pachchigar Homoeopathic Hospital and from peripheral OPDs. 

4. Sample size: 30 patients. 

5. Sampling techniques: simple random sampling. 

6. Study duration: 9 months.

7. Selection criteria.

v  Inclusion criteria: 

Ø  Patient covering DSM-5 criteria for depressive disorder.

Ø  Patient of 25 to 45 year age group.

Ø  Adults who is employed.

Ø  Both sex will be included.

v  Exclusion criteria: 

Ø  Below 25 and above 45 year of age group is excluded.

Ø  Patient already on antidepressants.

Ø  Patients with known case of serious medical illness, co-morbidity.

Ø  Patients having depression due to any neurological, endocrinological, metabolic, medication and substance related disorders.

v  Data analysis and methods:

Ø  Improved: Subjects showing a clinically marked increase in productivity of work and decrease in intensity and severity of disease.

Ø  Not Improved: No clinically favourable improvement after medicinal interventions. Adults with aggravated scores in their respective scoring scales.

Ø  Left the treatment: subjects who will not maintain follow-ups till advised to discontinue treatment.

 

7.4

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

 

The diagnosis of the case will be done on the basis of the case history and

clinical findings. Special investigations will be done as and when required.

7.5

HAS ETHICAL CLEARANCE BEEN OBTAIN FROM YOUR  INSTITUTE?

Yes, ethical clearance has been obtained from the institution.

 

 

 

 

 

 

 

.

 

Bibliography

1.

www.who.int. [Online]. Available from: https://www.who.int/teams/mental-health-and-substance-use/promotion-prevention/mental-health-in-the-workplace#:~:text=An%20estimated%2015%25%20of%20working,cost%20the%20global%20economy.

2.

Melchior M, AVSHALOM C, BARRY J M, ANDREA D, RICHIE P, TERRIE E. M. Work stress precipitates depression and anxiety in young, working women and men. 2007 Apr; 37(8).

3.

jake. gemini TMS. [Online]. [cited 2022 5 23. Available from: https://www.geminitms.com/how-depression-affects-work-performance/.

4.

hahnemann S. Organon of medicine: B. Jain; 2016.

5.

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

6.

Ministry of Health and Family Welfare. [Online]. Available from: http://main.mohfw.gov.in.

7.

sadock VA, Pedro R, Benjamin J S. Kaplan & Sadock’s Comprehensive Textbook of Psychiatry: Lippincott, Wiliams & Wilkins; 2017.

8.

Association AP. Diagnostic and statistical manual of mental disorders. 5th ed.: American Psychiatric Association; 2013.

9.

Bartolomucci A, Rosario L, Bernhard B. stress and depression: Preclinical Research and Clinical Implications. PLoS ONE. 2009 Jan; 4(1): e4265.

10.

Clifford T M, Richard A K, John R. W, John S. Introduction to psychology. 7th ed.: Mcgraw-hill; 2017.

11.

Boericke W. Boericke’s Materia Medica with Repertory; 1991.

12.

Joseph R. Kaplan & sadock’s synopsis of psychiatry. 12th ed. philadelphia: Wolters Kluwer; 2021.

13.

King MA. Introduction to psychology: New york [U.A.]; 1971.

 

 


 
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