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CTRI Number  CTRI/2025/01/079151 [Registered on: 21/01/2025] Trial Registered Prospectively
Last Modified On: 30/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Understanding the Management of Adjustment Disorder In Homoeopathy 
Scientific Title of Study   To Study On Adjustment Disorder In The Early Adulthood 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  Vishva chamanbhai patel 
Designation  M.D. Scholar Part - 2 
Affiliation  C.D. Pachchigar College of Homoeopathic Medicine and Hospital 
Address  Department of homoeopathic psychiatry division of MD 2nd floor C.D. Pachchigar College of Homoeopathic Medicine and Hospital Surat

Surat
GUJARAT
395001
India 
Phone  8401335091  
Fax    
Email  vishvapatel897@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 Gujrat India 395001

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 Gujrat India 395001

Surat
GUJARAT
395001
India 
Phone  9403803599  
Fax    
Email  deepti.yesade81@gmail.com  
 
Source of Monetary or Material Support  
C D Pachchigar Collage of Homoeopathic Medicine And Hospital Near Anand Mangal Society Udhana Magdalla Road Surat 395001 Gujrat India 
 
Primary Sponsor  
Name  C D Pachchigar Collage of Homoeopathic Medicine And Hospital  
Address  C D Pachchigar Collage 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 
Dr Vishva Chamanbhai Patel  C D Pachchigar Collage of Homoeopathic Medicine And Hospital  Department of Homoeopathic Psychiatry Division Of 2nd Floor, Surat, Gujrat
Surat
GUJARAT 
8401335091

vishvapatel897@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: F432||Adjustment disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic Medicines  Homoeopathic Medicine Dose As Per Requirement Of Case Through Sublingual Mode Of Administration Within Time Duration Of 9 Months  
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Patient Covering Diagnostic Criteria Of DSM-5 For Adjustment Disorder 
 
ExclusionCriteria 
Details  Patients with Critical Ill Condition, Any Mental Organic Disorder, Having Any Other Neuro-developing Disorder 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To Study The Homoeopathic Management In Adjustment Disorder.  9 Month 
 
Secondary Outcome  
Outcome  TimePoints 
Study of the Clinical Presentation Of Adjustment Disorder In Early Adulthood.  9 month  
 
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)   29/01/2025 
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  


NEED  FOR  THE  STUDY:

 

We live in a century where people more suffer from mentally disturbed state rather than physical conditions. Mental health includes our emotional, psychological, and social wellbeing. It affect how we think, feel, and act. It also helps determine how we handle stress, relate to others and make healthy choices.

The battle for existence and survival is a never ending series of events throughout life. If the results are not according to our expectations, we change our goal. After the initial failure living organisms likes shifting to more defensive position in order to face the challenges of circumstances. This feature of the living organism is called adjustment.

On the basis of relationship of living organisms with the environment and their relationship with self, they can be considered as maladjustment or adjusted. Maladjusted person cannot be able to adjust with his environment easily. If the living organisms face problem in adjustment with the environment or with the self then it will leads to stress.

Adjustment disorder is an unexpected strong emotional or behavioral reaction that occurs in response to an identifiable stressful life change that occurred within the previous three month.

The percentage of individuals in outpatient mental health treatment with a principal diagnosis of an adjustment disorder ranges from approximately 5% to 20%. In a hospital psychiatric consultation setting, it is often the most common diagnosis, frequently reaching 50%. (1)

Stressful events have significant negative impact on the individual, or a group of people taking in to consideration of external context and cultural factor.

Development of such emotional symptoms to particular stressful incidence might not that much intent for other but for that particular person this incidence may have mark psychological meaning which leads to adjustment disorder.

Homoeopathy could play greater role for an effective management of the symptoms of adjustment disorder is evident considering fact that it is a holistic treatment approach and had durable impact. Homoeopathy treats the patients on all levels, the spiritual, mental/emotional and physical plane; the planes on which the symptoms of adjustment disorder are manifest and express. The study aims to provide valuable insights in to clinical presentation of adjustments disorder and studying the management of it with homoeopathy.



REVIEW OF LITERATURE:

  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


 

 

 

 

 

 

 INTRODUCTION:

Those who has not mastered earlier development tasks take  

         Longer and harder to adjust. (2)

 

The adjustment disorders are a diagnostic category characterized by an emotional response to a stressful event. There are currently no such criteria for the stressor of an adjustment disorder. There is little specificity to qualify these symptoms other than an excess of what would be expected from the particular stressor or a significant social or occupational impairment. By definition, the symptoms must begin within 3 months of the stressor, and must remit within 6 months of removal of the stressor. (3)

 

 EPIDEMIOLOGY:

The prevalence of the disorder is estimated to be from 2 to 8 percent of the general population.

Women are diagnosed with the disorder twice as often as men, and single women are generally overly represented as most at risk.

The disorders can occur at any age but are most frequently diagnosed in adolescents.

Among adolescents of either sex, common precipitating stresses are school problems, parental rejection and divorce, and substance abuse.

Among adults, common precipitating stresses are marital problems, divorce, moving to a new environment, and financial problems.

Adjustment disorders are one of the most common psychiatric diagnoses for disorders of patients hospitalized for medical and surgical problems. (4)

Stressors and symptoms may vary depending on cultural influences (5)

 

 

ETIOLOGY

By definition, an adjustment disorder is precipitated by one or more stressors. The severity of the stressor or stressors does not always predict the severity of the disorder; the stressor severity is a complex function of degree, quantity, duration, reversibility, environment, and personal context. (3)

Psychodynamic Factors Pivotal to understanding adjustment disorders is an understanding of three factors: the nature of the stressor, the conscious and unconscious meanings of the stressor, and the patient’s preexisting vulnerability. A concurrent personality disorder or organic impairment may make a person vulnerable to adjustment disorder (4)

 

 

 DIAGNOSIS AND CLINICAL FEATURE

Disorders follow a stressor, the symptoms do not necessarily begin immediately. Up to 3 months may elapse between a stressor and the development of symptoms. Symptoms do not always subside as soon as the stressor ceases; if the stressor continues, the disorder may be chronic. (3)

 

DISGNOSTIC CRITERIA FROM DSM-5

 

A.    The development of emotional or behavioral symptoms in response to an identifiable stressor occurring within 3 months of the onset of the stressor.

B.    These symptoms or behaviors are clinically evident, as evidenced by one or both of the following:

a.    Marked distress that is out of proportion to the severity or intensity of the stressor, taking into account the external context and the cultural factors that might influence symptom severity and presentation.

b.    Significant impairment in social, occupational, or other important areas of functioning.

C.   The stress-related disturbance does not meet the criteria for another Disorder

D.   Mental disorder and is not merely an exacerbation of a preexisting Mental Disorder.

E.     Do not persist for more than an additional 6 months. (1)

 

 SUB TYPES OF ADJUSTMENT DISORDER

1.    with depressed mood:

2.    with anxiety:

3.    with mixed anxiety and depressed mood:

4.    with disturbance of conduct:

5.    with mixed disturbance of emotions and conduct:

6.    Unspecified: (1)

 DIFFERENTIAL DIAGNOSIS:

Major depressive disorder.

Posttraumatic stress disorder and acute stress disorder.

Personality disorder.

Psychological factors affecting other medical conditions.

Normative stress reactions (3)

 

 COMORBIDITY

Adjustment disorders can accompany most mental disorders and any medical disorder. Adjustment disorders can be diagnosed in addition to another mental disorder only if the latter does not explain the particular symptoms that occur in reaction to the stressor. (1)

 

 COURCE AND PROGNOSIS:

With appropriate treatment, the overall prognosis of an adjustment disorder is generally favorable. Most patients return to their previous level of functioning within 3 months. Some persons (particularly adolescents) who receive a diagnosis of an adjustment disorder later have mood disorders or substance related disorders. Adolescents usually require a longer time to recover than adults. (3)

 

 GENERAL MANAGEMENT:

Supportive Psychotherapy is the most appropriate choice in the management of adjustment disorders.

Crisis intervention helps patients to efficiently solve their life situation that has led to the clinical condition of adjustment problems.

Stress management techniques and coping methods help the patients cope with their problems in a better way. (6)

 

HOMOEOPATHIC APPROACH

Homoeopathy recognizes the individuality of each patient or case. The entire examination of a patient is conducted with a view to discovering not only the general or common features of the case by which it may be classified diagnostically and pathologically, but the special and particular symptoms which differentiate the case from others of the same general class. It recognizes the fact that no two cases or patients, even with the same the disease, are exactly alike, and maintains that a true science of therapeutics must enable the practitioner to recognize these differences and find the needed remedy for each individual. In actual practice the “differences” are very often the deciding factor in the choice of remedy. To use frequently quoted epigram: “Homoeopathy does not treat disease. It treats the patients. (6)

 

According to aphorism 215-216 Hahnemann considers mental disease as one sided disease of the chronic type affecting the whole psychosomatic entity. (7)

 

 

 

 

SOME HOMOEOPATHIC MEDICINE SUITABLE FOR AD. (8)

 

 

1.    GELSEMIUM SEMPERVIRENS

2.    IGNATIA

3.    STAPHYSAGRIA

4.    ARUM METALLICUM

5.    SILICEA

6.    NATRUM MUR

7.    OPIUM

8.    PH-AC

 


 OBJECTIVES OF THE STUDY

 

TO ASSESS THE EFFECTIVENESS OF HOMOEOPATHIC MANAGEMENT IN CASES OF ADJUSTMENT DISORDER IN EARLY ADULTHOOD.

TO STUDY THE CLINICAL PRESENTATION OF ADJUSTMENT DISORDER IN EARLY ADULTHOOD.

 


MATERIALS AND METHODS

 


SOURCES OF DATA:

O.P.D &I.P.D of C.D Pachchigar homoeopathic medical college and hospital.

Peripheral Centre and regular camp visit of C.D. Pachchigar homoeopathic medical college and hospital.      


MATERIAL

Materials utilized in study consist of –

1.    Collage O.P.D standard case taking format.

2.    Homoeopathic computer software: RADAR10.

3.    BOOKS – psychiatry, psychology, organon of medicine, material medica, & repertory, all homoeopathic books & literature related to topic, soft and hard research material.


METHODS OF COLLECTION OF DATA:

Study design – Prospective Experimental study.

Sample size –   30 cases.

Sample technique – simple randomized.

Study duration- 9 month.

Selection criteria –

1.    Inclusion criteria-

                                 Age group 18 to 40.

                      Both sexes will be considered irrespective of socio-economic condition & religion.

                     Patients covering diagnostic criteria of DSM-5TR for adjustment disorder.

2.    Exclusion criteria-

                                      Critically ill patients.

                                      Patients with organic mental disorder.

                                    Patients undergoing treatment for any other chronic disease.

                                  Patients having other neuro-developmental disorder.

 

Case Taking Will Be Done according To Guidelines Mentioned by Dr. Hahnemann in aphorisams 83-104.

After proper analysis and evaluation of symptoms, totality of symptoms will be formed.

Totality formation will be done as per the instruction given by Dr. Hahnemann in organ on of medicine.

The remedy will be selected on basis of totality of symptoms and either from reportorial or non-reportorial approach.

Potency selection and repetition are done according to principles laid down in organon of medicine.

 

RESPONSE WILL BE ANALYSED IN TO FOLLOWING 3 CRITERIA

 

IMPROVED- patients showing a clinically marked improvement in personal, social, academic life. Marked improvement in respected psychological scoring scales.

NOT IMPROVED – no clinically improvement after medicinal interventions. Scoring scales may increase or may remain same as previous.

LEFT THE TREATMENT-patients who will not maintain follow –ups.

 


DOES THE STUDY REQUIRE ANY INVESTIGATION TO BE CONDUCTED ON PATIENTS OR OTHER HUMAN 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.


HAS ETHICAL CLEARANCE BEEN OBTAIN FROM YOUR INSTITUTE?

Yes


 



BIBLIOGRAPHY:

 

 

1.

Association AP. Diagnosis and Statistical Manual of Mental Disorder. 5th ed. WASHINGTON,DC,USA: American Psychiatry Association; 2013.

2.

Tamboli DMP, editor. Foundation of Psychology & Homoeopathy. 1st ed. Palghar: Dr. M.L.Dhawle memorial trust; 2023.

3.

Benjamin James Sadock MVAS. Kaplan& Sadock’s Synopsis of Psychiatry Behavioural Science/clinical Psychiatry. 11th ed. New York: Wolters Kluwer; 2015.

4.

Benjamin James Sadock MVAS. Kaplan&Sadock’s Comprehensive Textbook of Psychiatry. 10th ed. Benjamin J. Sadock MVAS, editor. New York: Wolters Kluwer; 2017.

5.

Agrawal DSA. Review on Adjustment Disorder with Various Aspect. Research Paper. Vadoddra: Parul Univercity, M.D,Hom,PHD; 2023.

6.

Lalithaa Dk. Efficacy of Homoeopathic Medicine in Adjustment Disorder among Collage freshers. International Journal of Homoeopathic Science. 2019 December; 1: 3.

7.

Hhnemann S. Organon of Medicine. 6th ed. Boericke W, editor. India; 2008.

8.

Boericke W. Pocket Manual of Homoeopathic Materia Medica. 9th ed. Oscar E. Boericke.a.b M, editor. Naw Delhi: Indian Books&Periodicals; 2011.

 

 

 

 

 

 

 

 

 

 


 
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