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CTRI Number  CTRI/2024/06/068645 [Registered on: 10/06/2024] Trial Registered Prospectively
Last Modified On: 14/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Retrospective Study 
Study Design  Other 
Public Title of Study   Understanding Mind Of Children Suffering From Attention Deficit Hyperactivity Disorder Of 5-18 Years, Providing More Effective Treatment Strategies For Treating The Child As a Whole. 
Scientific Title of Study   Exploring Various Mental States In Children Suffering From Attention Deficit Hyperactivity Disorder In Age Group Of 5-18 Years : A Retrospective Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Yashasvee Tinopalchandra Modi 
Designation  M D Scholar Part 1 
Affiliation  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

Surat
GUJARAT
395001
India 
Phone  9913891448  
Fax    
Email  yashasveemodi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Shilpa Sudhakar Mehkarkar 
Designation  Associate Professor And Head of Department of Pediatrics 
Affiliation  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 Gujarat India

Surat
GUJARAT
395001
India 
Phone    
Fax    
Email  drshilpraj21nov@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Yashasvee Tinopalchandra Modi 
Designation  M D Scholar Part 1 
Affiliation  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 395007 Gujarat India

Surat
GUJARAT
395001
India 
Phone  9913891448  
Fax    
Email  yashasveemodi@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 Gujarat 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 
Yashasvee Modi  C D Pachchigar College Of Medicine And Hospital  Department Of Pediatrics , Division of MD, 2nd floor
Surat
GUJARAT 
9913891448

yashasveemodi@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: F909||Attention-deficit hyperactivity disorder, unspecified type,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Diagnosed cases of attention deficit hyperactivity disorder  
 
ExclusionCriteria 
Details  1. Children below 5 years

2. Children having other behavioral disorders  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
This research aims to explore the individualized mental states in children with attention deficit hyperactivity disorder within the realm of homoeopathy Understanding these mental states is crucial for enhancing the overall wellbeing and potential of each child contributing to a better quality of life  9 Months 
 
Secondary Outcome  
Outcome  TimePoints 
This exploration fosters a deeper comprehension of the fundamental nature of attention deficit hyperactivity disorder and its intricate relationship with the disease producing phenomenon propelling us toward more effective treatment strategies  This exploration fosters a deeper comprehension of the fundamental nature of attention deficit hyperactivity disorder and its intricate relationship with the disease-producing phenomenon, propelling us toward more effective treatment strategies 
 
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)   19/06/2024 
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)  Open to Recruitment 
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
Modification(s)  

NAME  OF  THE CANDIDATE  AND  ADDRESS:

YASHASVEE TINOPALCHANDRA MODI

A-62, BHAGYALAXMI SOCIETY, PART-1, NEAR SURAJ HOSPITAL, PIPLOD, SURAT- 395007

NAME  OF  THE

INSTITUTION:

C. D. PACHCHIGAR COLLEGE OF HOMOEOPATHIC MEDICINE & HOSPITAL; NEAR NAVJIVAN CIRCLE, UDHANA MAGDALLA ROAD, SURAT- 395001

COURSE  OF  THE  STUDY  AND SUBJECT:

M.D. (HOMOEOPATHY)

PAEDIATRICS

DATE  OF ADMISSION  TO COURSE:

10TH APRIL 2023

TITLE  OF  THE TOPIC:

 

EXPLORING VARIOUS MENTAL STATES IN CHILDREN SUFFERING FROM ATTENTION DEFICIT HYPERACTIVITY DISORDER IN AGE GROUP OF 5-18 YEARS: A RETROSPECTIVE STUDY

BRIEF  RESUME  OF  INTENDED  WORK:

NEED  FOR  STUDY:

Ø  “Today’s children are tomorrow’s citizens” is a widely acknowledged truth, stating that the seeds of the future society are in the children of the present day. The American Academy of Paediatrics (AAP) Committee on Psychosocial Aspects of Child and Family Health highlights the need to understand the developmental history of new health challenges in children. They stressed the need to emphasize the growing impact of chronic physical and behavioral conditions in paediatric care. The American Academy of Paediatrics asserts that preventing, detecting early, and managing these health issues should be a key focus in paediatrics. (1) 

Ø  In paediatric practice; attention deficit hyperactivity disorder is one of the most common serious psychosocial problems prompting parents to seek help for their children. Since the ability to pay attention and concentration is a basis prerequisite of child development, forming the foundation of all learning and thinking as well as of emotional and social interaction, the suffering of these children should be considerable. (2)

Ø  Centers for Disease Control and Prevention conducts research to expand on what is known about Attention deficit hyperactivity disorder. (3) When treating any illness, like Attention deficit hyperactivity disorder, it’s crucial to consider the patient’s overall life situation to ensure a comprehensive approach. Understanding how the condition impacts different aspects of a child’s life is essential for effective treatment.

Ø  Unlike just addressing the disease, homoeopathy focuses on treating the entire child, considering both physical symptoms and mental well-being. The mental state plays a key role in the origin, persistence, and progression of the disease. Homoeopathic practitioners analyze a child’s inner disturbances by observing their emotions, intelligence, and behavior. This detailed mental state assessment helps understand the child’s current condition, development, and how they relate to their suffering. (4)

Ø  This research aims to explore the individualized mental states in children with attention deficit hyperactivity disorder within the realm of homoeopathy. Understanding these mental states is crucial for enhancing the overall well-being and potential of each child, contributing to a better quality of life. 

Ø  Given the scarcity of research on mental states and Attention deficit hyperactivity disorder in the field of homeopathy, this study seeks to contribute valuable references for both the scientific community and practitioners dealing with its cases. This research can serve as a basis for developing expertise in using homoeopathic treatments specifically for children with attention deficit hyperactivity disorder.

 

REVIEW  OF  LITERATURE:

INTRODUCTION: (1) (5) (6) 

Ø  Attention-deficit/hyperactivity disorder (ADHD) is the most common neurobehavioral disorder of childhood, among the most prevalent chronic health conditions affecting school-aged children, and one of the most extensively studied neurodevelopmental disorders of childhood. It is characterized by inattention, including increased distractibility and difficulty sustaining attention; poor impulse control and decreased self-inhibitory capacity; motor over activity and motor restlessness. (1)

Ø  While attention deficit hyperactivity disorder was initially seen as a childhood condition, recent research indicates that it can persist into adolescence and adulthood. In addition to learning challenges, it can lead to increased risks such as traffic accidents, antisocial behaviour, and criminal involvement among adolescents, adversely affecting both families and society. (5) (6)

PREVALENCE : (6) (7)

Ø  It affects around 7.2% of children globally, but its prevalence varies widely across different countries, ranging from 0.1% to 10.2% among children and adolescents. (6)

Ø  A recent review on attention deficit hyperactivity disorder among children in India found: (7)

o   Its prevalence varies from 1.30% to 28.9%, with a pooled prevalence of 7.1%.

o   Male children have a 9.40% prevalence, while female children have a 5.20% prevalence.

o   The age range for prevalence is 8 to 15 years for males and 7.6 to 15 years for females.

o   These findings indicate that it is widespread among Indian children, aligning with global trends.

AETIOLOGY: (1) (2) (5) (8)

Ø  Attention deficit hyperactivity disorder is a complex condition with genetic, environmental, and neurological factors influencing its development. (1)

Ø  There’s a strong genetic link, associations have been reported with variations in genes for the dopamine receptors 4 (DRD4) and 5 (DRD5) and a dopamine transporter (DAT1). (2)

Ø  In studying attention deficit hyperactivity disorder, experts are looking closely at dopamine. They focus on the prefrontal cortex, an area that uses a lot of dopamine and connects with other brain parts responsible for attention, decision-making, memory, and control. This helps us understand how symptoms may arise. (8)

Ø  Brain abnormalities include dysregulation of frontal subcortical circuits, small cortical volumes, widespread brain volume reduction, and cerebellum abnormalities. Brain injury and attention deficit hyperactivity disorder may have a bidirectional relationship, with each potentially increasing the risk of the other. (1)

Ø  Some factors linked to it include birth complications like toxaemia, prolonged labor, complicated delivery, premature birth, low birth weight. (1)

Ø  Maternal drug use, including smoking, alcohol consumption during pregnancy, and exposure to lead, may contribute to attention difficulties in children with attention deficit hyperactivity disorder (1)

Ø  Food coloring and preservatives inconsistently show a connection to increased hyperactivity. (1)

Ø  Psychosocial family stressors like poverty, unwanted pregnancy, family structure, parental psychiatric disorders, low parental education, mother’s occupation, low socioeconomic status, male gender, birth order, single parenthood, prolonged use of mobile phones, exposure to violence and undernutrition or malnutrition can contribute or worsen symptoms. (1) (5)

SYMPTOMS  &  DIAGNOSTIC  CRITERIA: (6) 

Ø  Many children may have struggle in sitting still, waiting their turn, paying attention, being fidgety, and acting impulsively. However, children who meet DSM-5 Diagnostic Criteria for Attention-Deficit/Hyperactivity Disorder, their hyperactivity, impulsivity, organization, and/or inattention are more than expected for their age or developmental level. These symptoms can cause a lot of trouble at home, school, or in relationships. 

Ø  There are three main types:

o   F90.0 Predominantly inattentive presentation

o   F90.1 Predominantly hyperactive/impulsive presentation

o   F90.2 Combined presentation 

Predominantly inattentive type : 

Ø  Inattentive refers to challenges with staying on task, focusing, and organization. 

Ø  For a diagnosis of this type of attention deficit hyperactivity disorder, six (or more) (or five for individuals who are 17 years old or older) of the following symptoms of inattention have persisted for ≥6 months to a degree that is inconsistent with development level and that negatively impacts directly on social and academic/occupational activities: 

a.  Often fails to give close attention to details or makes careless mistakes in schoolwork, at work, or during other activities (e.g., overlooks or misses details, work is inaccurate).

b.     Often has difficulty sustaining attention in tasks or play activities.

c.     Often does not seem to listen when spoken to directly.

d.  Often does not follow through on instructions and fails to finish schoolwork, chores, or duties in the workplace (not due to oppositional behaviour or failure to understand instructions).

e.     Often has difficulty organizing tasks and activities.

f.    Often avoids, dislikes, or is reluctant to engage in tasks that require sustained mental effort (e.g., schoolwork, homework).

g. Often loses things necessary for tasks or activities (e.g., toys, school assignments, pencils, books, tools).

h.  Is often easily distracted by extraneous stimuli. I.e. is often forgetful in daily activities.

Predominantly hyperactive/impulsive type:

Ø  Hyperactivity refers to excessive movement such as fidgeting, excessive energy, not sitting still, and being talkative. Impulsivity refers to decisions or actions taken without thinking through the consequences.

Ø  For a diagnosis of this type of attention deficit hyperactivity disorder, six (or more) (or five for individuals who are 17 years old or older) of the following symptoms have persisted for at least 6 months to a degree that is inconsistent with developmental level and that negatively impacts directly on social and academic/occupational activities:

a.     Often fidgets with hands or feet or squirms in seat.

b.     Often leaves seat in classroom or in other situations in which remaining seated is expected.

c.      Often runs about or climbs excessively in situations in which it is inappropriate (in adolescents or adults, may be limited to subjective feelings of restlessness).

d.     Often has difficulty playing or engaging in leisure activities quietly.

e.     Is often “on the go” or often acts as if “driven by a motor.”

f.       Often talks excessively. Impulsivity.

g.     Often blurts out answers before questions have been completed.

h.     Often has difficulty awaiting turn.

i.       Often interrupts or intrudes on others (e.g., butts into conversations or games). 

Combined type:

Ø  This type of attention deficit hyperactivity disorder is diagnosed when both criteria for both inattentive and hyperactive/impulse types are met.

Ø  A diagnosis is based on the presence of (A) persistent symptoms that have occurred over a period and are noticeable over the past six months. While attention deficit hyperactivity disorder can be diagnosed at any age, this begins in childhood. When considering the diagnosis, (B) the symptoms must be present before the individual is 12 years old and (C) must have caused difficulties in more than one setting. Evidence suggests that (D) the symptoms interfere or reduce the quality of, social, academic, or occupational functioning, & (E) symptoms do not occur exclusively during the course of schizophrenia or another psychotic disorder and are not better explained by another mental disorder. However, it can be present in mild, moderate, or severe form. 

ASSOCIATED  DIFFICULTIES   IN CHILDREN  WITH  attention deficit hyperactivity disorder: (1)

Ø  Children with attention deficit hyperactivity disorder display several other difficulties in addition to their core symptoms. If not handled properly, it can be tough for parents, and the child may deal with issues like struggling in school, underachievement, behaviour and emotional problems, difficulty making relations & employment difficulties as they grow older. 

Ø  About 15-25% of children with attention deficit hyperactivity disorder have learning disabilities, 30-35% have language issues, 15-20% have mood disorders, and 20-25% also experience anxiety. It can also come with other conditions like sleep problems, memory issues, and reduced motor skills. 

EVALUATION AND MANAGEMENT OF A CHILD WITH attention deficit hyperactivity disorder: (1) (9)

Ø  Diagnosing and treating a child with this disorder requires a team of experts. A physical check-up and some tests may be done if needed based on the child’s history or symptoms. A thorough psychiatric evaluation is essential to identify any other problems that may seem like it.

Ø  Several well-known behaviour rating scales effectively distinguish between children with attention deficit hyperactivity disorder and those without. These include the Vanderbilt ADHD Diagnostic Rating Scale, Conner Rating Scales (for parents and teachers). Additionally, broader checklists like the Behavioral Assessment Scale for Children (BASC) are helpful, especially when a child may have other issues like anxiety, depression, or conduct problems.

Ø  According to the American Academy of Paediatrics (AAP) guidelines (2011) behaviour therapy is recommended as the first line of treatment for attention deficit hyperactivity disorder in young children and should be tried before medical therapy. The most widely used medications for the treatment are the psychostimulant medications, including methylphenidate, dexmethylphenidate, amphetamine, and various amphetamine and dextroamphetamine preparations. A combination of stimulants and psychosocial interventions in which the parents and teachers work as partners with the paediatrician and clinical psychologist, can help a vast majority of children with this disorder.

HOMOEOPATHY &  MENTAL STATES:

ADDRESSING ATTENTION DEFICIT HYPERACTIVITY DISORDER : (4) (10) (11) (12)

Ø  Human growth, studied in developmental psychology, involves the interplay of nature and nurture. It encompasses physical, behavioral, cognitive, and personality changes from conception through childhood and beyond. A child’s expressions, influenced by both inherited biological characteristics and environmental influences, forms the canvas upon which their personality is painted. (10)

Ø  From the very inception of life, a child’s emotional palette begins to unfold, which closely tied to their physical and biological needs. The primal expressions of basic emotions, rooted in the pursuit of physical protection or survival. As children mature, their emotional palette broadens to include more complex sentiments like sadness, anger, and fear. These emotional reactions, often transient in nature, may crystallize into more enduring ’states’ and eventually mold into persistent ’moods,’ shaping the child’s perception and interaction with the world. (10)

Ø  The culmination of these emotions forms what is termed a ’mental state’- A mosaic of symptoms shaped by environmental circumstances and individual disposition. This mental state serves as a barometer, providing insights into the individual’s present phase, evolution, and relationship to suffering. (4) Recognizing the significance of mental states, especially in childhood, is crucial for a homeopathic physician. Proficiency in identifying common emotional traits allows physician to distinguish ’normal’ from ’abnormal’ symptoms, paving the way for precise and successful prescriptions. 

Ø  Reflection in Aphorism 211 “the state of disposition of the patient often chiefly determines the selection of homoeopathic remedy, as being characteristic symptom which can least of all remain concealed from the accurately observing physicians” brings the idea that the characteristic state of disposition cannot escape the keen observation of a skilled physician. (12) Understanding the precise state of mind generating symptoms, guiding the selection of an appropriate remedy. So far the efforts at curing patients depends on one’s ability in hunting through the mass of symptoms. (11) Establishing a precise hierarchy of mental states, Kent emphasized the paramount importance of prioritizing them.

Ø  Children with attention deficit hyperactivity disorder might find themselves struggling in school tasks and activities, leading to a cycle of perceived failure. This cycle can contribute to a sense of shame, as they may feel inadequate compared to their peers. It’s essential to approach such disorder from an individualized perspective too, as each child’s experience with attention deficit hyperactivity disorder is unique.

Ø  Thus, delving into the psyche of attention deficit hyperactivity disorder children unveils the foundations of their mental states, providing a comprehensive perspective for treating the child as a whole. This exploration fosters a deeper comprehension of the fundamental nature of attention deficit hyperactivity disorder and its intricate relationship with the disease-producing phenomenon, propelling us toward more effective treatment strategies.

OBJECTIVE  OF  THE  STUDY:

•   To explore various mental states in patients suffering from Attention Deficit Hyperactivity Disorder.

material  and  methods:

SOURCES  OF  DATA:

Ø  PROJECT SITE:

•        Institutional Out Patient Door.

•        Camps arranged by the institute.

MATERIALS:

•      Case records from institute.

METHOD  OF  COLLECTION  OF  DATA:

1.     Study Design: Observational study 

2.     Study Type: Retrospective study

3.     Study Population: Children suffering attention deficit hyperactivity disorder recorded in institute.

4.     Sample Size:30 Cases 

5.     Sample Techniques: Simple Random Sampling

6.     Selection Criteria:

Ø  Inclusion criteria: 

1.     Age group of 5-18 years 

2.     Sex : Male & Female 

3.     Diagnosed cases of attention deficit hyperactivity disorder 

Ø  Exclusion criteria: 

1.     Children below 5 years 

2.     Children having other behavioral 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.

Kliegman SGBSTW. NELSON TEXTBOOK OF PEDIATRICS. 21st ed.: Elsevier; 2020.

2.

Panchal DN. Role of Homoeopathic Remedies in Treatment of ADHD. The International Journal of Indian Psychology. 2016; 3(4): 33.

3.

Prevention CfDCa. Research on ADHD. [Online].; 2024 [cited 2024 Jan. Available from: https://www.cdc.gov/ncbddd/adhd/research.html.

4.

Dhawale ML. I.C.R. Operational Mannual: The Art and the science of Standardized Homoeopathic Practice, Education and Training Mumbai: Dr. M.L. Dhawale Memorial Trust; 2003.

5.

Aby Dany Varghese GMCX. Attention Deficit Hyperactivity Disorder and Use of Mobile Phones among Children- Need for Concern? Journal of Clinical and Diagnostic Research, India. January,2023; 17(6): SC01-SC04.

6.

Association AP. Diagnostic and statistical manual of mental disorders : DSM-5-TR / American Psychiatric Association. Fifth edition, text revision. ed. Washington, DC: American Psychiatric Association; 2022.

7.

Joseph JK, Devu BK. Prevalence of Attention-Deficit Hyperactivity Disorder in India. Indian Journal of Psychiatric Nursing. February,2019; 16(2): 118-125.

8.

Benjamin James Sadock VASPR. Kaplan & Sadock’s Synopsis of Psychiatry : behavioral Sciences/Clinical Psychiatry. 11th ed.: Wolters Kluwer; 2015.

9.

Psychiatry.org - What is ADHD? [Online].; 2024 [cited 2024 January 28. Available from: https://www.psychiatry.org/patients-families/adhd/what-is-adhd.

10.

Master FJ. Clinical Observations of Children’s Remedies. Third Expanded ed.: Lutra; 2006.

11.

Dhawale ML. Symphosium on Hahnemannian Totality. 3rd ed. Mumbai: Dr.M.L. Dhawale Trust; 2014.

12.

B. K. Sarkar RED. Hahnemann’s Organon Of Medicine. 20162017th ed.: Birla Publications Pvt. Ltd..



I have initiated the recruitment process for cases in my study. Screening and selection of eligible participants are currently underway, with strict adherence to the inclusion and exclusion criteria. 
 
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