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CTRI Number  CTRI/2025/01/079335 [Registered on: 24/01/2025] Trial Registered Prospectively
Last Modified On: 22/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Exploring Anxiety Manifestations in Dermatological Diseases Among Children and Their Representations in Kents Repertory 
Scientific Title of Study   Exploring Various Expressions Of Anxiety In Dermatological Diseases In Paediatric Age Group And Finding Its Representations In Kents Repertory 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mustufa Akbar Naviwala 
Designation  M.D. Scholar part 2 
Affiliation  C D Pachchigar College Of Homoeopathic Medicine And Hospital 
Address  Department Of Paediatrics Division Of MD 2nd floor CD Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat
Department Of Paediatrics Division Of MD 2nd floor CD Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat
Surat
GUJARAT
395001
India 
Phone  9601283042  
Fax    
Email  mustufanaviwala12345@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aditya Garg 
Designation  Associate Professor Department Of Paediatrics 
Affiliation  C D Pachchigar College Of Homoeopathic Medicine And Hospital 
Address  Department Of Paediatrics Division Of MD 2nd floor CD Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat
Department Of Paediatrics Division Of MD 2nd floor CD Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat
Surat
GUJARAT
395001
India 
Phone  7249275743  
Fax    
Email  adityagarg7978@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aditya Garg 
Designation  Associate Professor Department Of Paediatrics 
Affiliation  C D Pachchigar College Of Homoeopathic Medicine And Hospital 
Address  Department Of Paediatrics Division Of MD 2nd floor CD Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat
Department Of Paediatrics Division Of MD 2nd floor CD Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat
Surat
GUJARAT
395001
India 
Phone  7249275743  
Fax    
Email  adityagarg7978@gmail.com  
 
Source of Monetary or Material Support  
Department Of Paediatrics Division Of MD 2nd floor CD Pachchigar College of Homoeopathic Medicine and Hospital Surat 395001 Gujarat 
 
Primary Sponsor  
Name  C D Pachchigar College Of Homoeopathic Medicine And Hospital 
Address  Department Of Paediatrics Division Of MD 2nd floor C D Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat 
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 
Mustufa Akbar Naviwala  C D Pachchigar College Of Homoeopathic Medicine And Hospital  Department Of Paediatrics Division Of MD 2nd floor CD Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat
Surat
GUJARAT 
9601283042

mustufanaviwala12345@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 Hopsital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic Medicine   Homoeopathic Medicine As Per Requirement Of Case Through Sublingual Mode Of Administration Within Time Duration Of 9 Months 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Those who are having chronic complaint 
 
ExclusionCriteria 
Details  Patient of age more than 18 years. Patient with irreversible pathological changes. Patient with behavioural and neurodevelopment disorders. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To Explore Whether There Is Any Correlation Between Anxiety And Its Expressions And Dermatological Diseases In Paediatric Age Group  To Explore Whether There Is Any Correlation Between Anxiety And Its Expressions And Dermatological Diseases In Paediatric Age Group manage within time period of 9 months. 
 
Secondary Outcome  
Outcome  TimePoints 
To Relief The Patients From Anxiety And Its Expressions And Dermatological Diseases And Also Relieving From Recurring Tendency Of Dermatological Diseases  To Improve The Patients Condition Within 3 Months And After that Will Assessed Recurrency Of Dermatological Diseases Within 9 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)   02/02/2025 
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  

Dermatological diseases represent some of the most common health concerns globally, affecting individuals across all age groups. The skin, being the largest and most exposed organ of the body, is particularly vulnerable to damage due to its constant interaction with the environment. Despite the wide prevalence of various skin conditions, many individuals may not recognize the extent of their skin-related issues, as conditions can range from mild irritations to chronic disorders. These dermatological diseases not only cause physical discomfort but also significantly impact an individual’s quality of life, contributing to increased absenteeism from work and school, especially in children.

The relationship between skin disorders and mental health is complex, as patients with dermatological issues often experience emotional distress. Among the various emotional conditions, anxiety is one of the most common psychological responses. While anxiety is a universal experience, the way it manifests can vary depending on age, individual temperament, and life circumstances. In children and adolescents, anxiety may present in unique ways compared to adults, making it essential for healthcare providers to understand these expressions fully. Anxiety in pediatric patients can range from transient symptoms to full-blown disorders, and it is often influenced by external factors such as physical illness, including dermatological diseases.

Despite the known correlation between anxiety and dermatological conditions, there is a gap in the literature concerning the specific manifestations of anxiety in pediatric dermatology. Previous research has mostly focused on anxiety disorders in general, often overlooking the nuanced ways in which anxiety is expressed in younger patients, particularly in relation to skin diseases. Additionally, there has been limited exploration into how these expressions of anxiety are reflected in classical homeopathic references, such as Kent’s Repertory.

This study aims to fill these gaps by examining how anxiety manifests in children and adolescents with dermatological diseases, identifying the factors that influence its expression, and exploring how these patterns are represented in Kent’s Repertory. By observing the finer details of anxiety’s manifestations in pediatric patients, this research seeks to provide valuable insights for more effective management and treatment strategies. Through this approach, it is hoped that clinicians will be better equipped to address both the physical and emotional needs of young patients, leading to more holistic and compassionate care.


BRIEF  RESUME  OF  INTENDED  WORK:

NEED  FOR  STUDY:

Ø  Dermatological diseases are among the most common health problem worldwide. Skin is extraordinary and largest organ of the body. It is frequently damaged because it is directly communicated with the environment. (1)

 

Ø  Skin disease is very common. However ‘healthy’ we think our skin is, it is likely that we will have suffered from some degree of skin disease and maybe one or other of the many common skin disorders. It is the second commonest cause of loss of work. Although it is not uncommon at any age. (1)

 

Ø  The child expresses his/her anxiety in different manner as compared to that of adult. Childhood and adolescence is the core risk phase for the development of symptoms and syndromes of anxiety that may range from transient mild symptoms to full-blown anxiety disorders. (2)

 

Ø  None of us are free from anxiety, although we do not suffer its consequences most of the time. That’s why physician needs to determine the nature, manner in which anxiety evolves in patient and the manner how it expresses to the observer (3). As there are varied expressions of anxiety, it becomes interest of this topic to explore such expressions through observation and case taking, so through this study it is easy to identify the pattern how it evolves, which factor affects the patient most and through this study it is easy for contributing valuable efforts for proper management.

 

Ø  Overviewing the previous researches it was observed that no study involved the expressions of anxiety especially in paediatric age group rather most researches include the anxiety disorders and so this study helps to explore finer anxiety expressions in paediatrics.

 

Ø  Moreover this study also focuses on finding the representation of various expressions of anxiety in Kent’s repertory

 

 

 

REVIEW  OF  LITERATURE:

 

Ø  Skin is an extraordinary structure. Skin or the integument is the largest organ of the body and constitutes 16% of the body weight (4). We are absolutely dependent on this barrier separating the potentially harmful environment from the body’s vulnerable interior (1). Approximately 30% of paediatric O.P.D attendance is accounted by dermatologic disorders as such or associates of other illness. Skin may also be an index of many systemic and genetic disorders. A vast majority of skin problems may be categorised as allergic, infective, vascular, pigmentary, scaly and hormonal.

 

Ø  Skin disorders though not frequently striking, can cause considerable discomfort and much disability. The disability caused is physical, emotional and socioeconomic, and patients are much helped by an appreciation of this and attempts by their physician to relieve the various problems that arise. The skin surface is the delineation between living processes and the potentially injurious outside world and has not only a symbolic importance because of this, but also the important task of preventing and controlling interaction between the outside and the inside (1).

 

Ø  Skin disorders may be generalized, localized to one or several sites of abnormality known as ‘lesions’, or eruptive, in which case many lesions appear spottily over the skin. Note that skin that appears normal to the naked eye may have structural abnormalities when inspected microscopically and may also demonstrate functional abnormalities (1).

 

Ø  WHAT IS ANXIETY?

 

Ø  Anxiety a normal (5) and natural human emotion, prompts a proactive and adaptive response to threatening or stressful situations (6). Anxiety is uneasy, fearful feeling Anxiety is a state of experience which is hazy, ill defined, vague, unrelated to any external object and therefore not specific no bounded. (3)

 

Ø  ANXIETY EVOLVES IN A DIFFERENT WAY:

 

Ø  Anxiety is a resultant of a faulty interaction between the individual and his life-situation. It expresses itself in diverse forms. (3)

 

Ø  From a physiological standpoint, anxiety is complexly linked to the autonomic nervous system [profuse perspiration, restlessness, etc.], the limbic system [poor memory, confusion, etc.], subcortical areas [stammering, loss of speech, etc.], and the hypothalamo-pituitary-suprarenal axis [nervous system disorders etc.]. Unresolved emotional conflicts and repressed thoughts contribute to effects at various levels of function and structure. The physician must navigate through these complexities, recognizing the mediating role of control mechanisms in the adaptation to stress, both physical and mental. (3)

 

Ø  The psychoanalytical model explains that anxiety often originates from early experiences like unwanted pregnancies, parental disapproval, separation, or loss during childhood. These events lay the foundation for adult anxiety, with adolescence adding new challenges such as sexual instincts and guilt complexes. Insecure and immature parents also play a role in creating anxiety during childhood and adolescence. (3)

 

Ø  Anxiety expresses in two ways:

Ø      [A] DIRECTLY

Ø      [B] INDIRECTLY

 

Ø  [A] ANXIETY EXPRESSES DIRECTLY: (3)

 

Ø  Anxiety may be anticipatory, agitational or depressive. This direct pathway of expression of Anxiety is often accompanied by other overflow symptoms resulting from the over-stimulation of the sympathetic nervous (3) system as follows :

1.     Psychomotor Expression: Nail biting, thumb sucking, etc.

2. Autonomic Expressions: Profuse perspiration, icy cold limbs, etc.

3. Impaired Intellectual Functioning:  Lack of concentration, lack of attention, etc,

4. Altered Perception:, A person’s perception can change, influencing how they interpret reality and experiences.

5. Emotional Accompaniments: Irritability, anger outbursts, etc.

     6. Impaired Relations with friends and family: Anxiety infiltrates into       interpersonal dynamics, affecting relationships with friends and family, often straining social connections.

 

Ø  [B] ANXIETY EXPRESSES INDIRECTLY : (3)

 

Ø  Anxiety, a complicated feeling, shows itself in various ways, often hidden behind how someone acts. As a physician, it is our duty to explore these indirect expressions for a thorough understanding and effective management of mental health. These expressions can fall into categories like neurotic, psychotic, and psychosomatic forms.

 

Ø  A] Neurotic Conversion: (3)

1.     Phobic Anxiety or Reactions: Claustrophobia.

2.     Obsessive-Anxiety or Obsessive-Compulsive Neurosis: Fixed ideas, etc.

3.     Hypochondriacal Anxiety: Excessive preoccupation with bodily functions, often focused on specific concerns like bowel movements.

4.     Iatrogenic Anxiety: Induced by medical professionals either intentionally or inadvertently, contributing to patient anxiety.

 

Ø  Anxiety also contributes to habit formation, especially in childhood, leading to conditions like stammering and facial tics. In childhood and adolescence, anxiety gives rise to personality disorders, behaviour disorders, habit disorders, psychosomatic disorders, and phobias. (3)

 

 

Ø   

Ø  B] Psychotic Conversion: (3)

Ø  In neurotic responses, the patient maintains contact with reality, but in psychotic responses, there is loss of contact. The patient turns inward,

isolates themselves, and withdraws from the environment, minimizing conscious anxiety.

 

Ø  C] Somatic Conversion { Somatization }: (3)

Ø  Anxiety expresses directly at the bodily level through functional and or structural alterations, termed as organ neurosis or psychosomatic disorders. Examples include tension headache, migraine, vertigo, genital, urinary, endocrine [PCOS], musculoskeletal, gastrointestinal, and nervous system disorders.

Ø  Sleep and Dreams- Disturbances in sleep, etc.

Dreams, the language of the subconscious, reflect the patient’s mental state.

 

Ø  KENT’S APPROACH FOR MAKING TOTALITY:

 

Ø  The key to understanding Kent’s contribution to the evolution of the Hahnemannian Totality lies in his assertion of the "Mind as the Key to the Man." According to Kent, mental symptoms, especially causative emotional modalities, hold the highest importance in symptomatology, followed by physical generals and characteristic particulars (6).

 

Ø  Kent dissected the mind into elements like will, understanding, memory, and affections, assigning the highest value to will and affections.

(6)

Ø  Kent’s breakdown of the mind into intellectual nature and affections is evident in his lectures , where he emphasizes that affections, though hidden, play a crucial role in human behavior. (6)

 

Ø  In disease, this harmonious functioning becomes deranged, yet Kent acknowledged the interrelationship between the mind and body, as seen in the Correspondence of Organs and the Direction of Cure. Kent’s evaluation of mentals distinguished between high-grade or qualified mentals and low-grade mentals, with the former considered crucial for the evolution of totality. (6)

 

Ø  Kent’s groundbreaking perspective on the mind as the key to understanding an individual’s totality has significantly influenced homeopathic practice. His intricate analysis of mental symptoms, will, affections, and intellectual functions has provided a framework for a holistic approach to case analysis, emphasizing the interconnectedness of mental and physical aspects in health and disease. (6)

 

Ø  Kent’s Repertory contains the entire spectrum of anxiety - descriptive, causative and the ailments resulting there from. No single human emotion can be studied in isolation as it forms a complex mosaic in close relation to other emotions. (3)

 

Ø  As the mind is a co-ordinate system, when one component is affected, the other components are bound to be affected. The repertory contains all the symptoms of the mind from which the mental state is to be derived by reference to the Homoeopathic Materia Medica. (3) (8)

 

Ø  Kent’s approach highlights that anxiety can show up in both mental and physical symptoms. In homeopathy, it’s crucial to thoroughly assess these expressions for an accurate prescription. This emphasizes the need for a detailed evaluation to tailor a precise and effective homeopathic treatment. (7)

 

 

OBJECTIVE  OF  THE  STUDY:

·       To explore various expressions of anxiety in dermatological diseases and to find their representations in Kent’s repertory.

·       To explore whether there is any correlation between anxiety and it’s expressions and dermatological diseases in paediatric.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

material  and  methods:

SOURCES  OF  DATA:

 

Ø  Project site – Institutional Out Patient Door.

 

MATERIALS:

·       Cases according to proforma prepared by institute.

 

METHOD  OF  COLLECTION  OF  DATA:

1.     Study design – Observational study.

2.     Study type – Prospective study.

3.     Study population – Cases having complain of dermatological diseases who treated with homoeopathic medicine at our institution.

4.     Sample size – 30 cases.

5.     Sampling techniques- Simple randomization.

6.     Selection criteria.

Ø  Inclusion criteria.

 

1.     Patient of age 6 months to 18 years.

2.     Patient of both sexes.

3.     Those who are having chronic complaint.

 

Ø  Exclusion criteria.

 

1.     Patient of age more than 18 years.

2.     Patient with irreversible pathological changes.

3.     Patient with behavioural and neurodevelopment disorders.

 

 

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

NO

 

HAS  ETHICAL  CLEARENCE BEEN  OBTAINED  FROM  YOUR INSTITUTE?

YES

Bibliography:

 

1.

marks R. Roxburgh’s Common Skin Diseases. 17th ed. Joanna Koster AU, editor.: Arnold publisher; 2003.

2.

Katja Beesdo SKDSP. Anixety And Anxiety Disorders in Children And Adolescence developmental issues and implications for DSM-5. National Library Of Medicine. 2011 january.

3.

Dhwale DML. Hahnemanian Totality Symphosium. 3rd ed.: Dr. M.L dhwale memorial trust; 2003.

4.

Munjal Y. API -Textbook of Medicine. 9th ed. Munjal Y, editor.: The association of physician of India.

5.

J.K trivedi PKG. An overview of Indian Resaerch in Anxiety Disorders. National Library of Medicine/ Indian journal of Psychiatry. 2010 january.

6.

Anbarasi Muthusamy RGPT. anxiety disorders amomg students of adplescence age group in selected school of Tiruchirapalli, south India : An analytical Cross sectional Study. Journal of Indian association for child and adolescence mental health. 2022 september.

7.

Dhawale DML. Hahnemanian totality symphosium. 3rd ed.: Dr. M.L. Dhwale memorial trust; 2014.

8.

tiwari DS. Essentials Of Repertorization. 5th ed.

9.

dhwale DML. Principle And Practice Of Homoeopathy. 4th ed.: B.Jain publisher; 2014.

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