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CTRI Number  CTRI/2025/01/078884 [Registered on: 17/01/2025] Trial Registered Prospectively
Last Modified On: 17/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Behavioral disorder in children and their homoeopathic management. 
Scientific Title of Study   Study on the behavioural disorders among school going children 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  Dr Archit Mehta 
Designation  PG student 
Affiliation  C. D. Pachchigar college of homoeopathic medicine and hospital 
Address  Department of Psychiatry; C. D. Pachchigar college of homoeopathic medicine and hospital, near anand mangal society, Udhana Magdalla road, Surat

Surat
GUJARAT
395001
India 
Phone  9408821101  
Fax    
Email  architmehta98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deepti Yesade 
Designation  Professor 
Affiliation  C. D. Pachchigar college of homoeopathic medicine and hospital 
Address  Departmrnt of Psychistry,C. D. Pachchigar college of homoeopathic medicine and hospital, near anand mangal society, Udhana Magdalla 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 
Affiliation  C. D. Pachchigar college of homoeopathic medicine and hospital 
Address  Department of Psychiatry, C. D. Pachchigar college of homoeopathic medicine and hospital, near anand mangal society, Udhana Magdalla 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 homoeopathic medicine and hospital, near anand mangal society, Udhana Magdalla road, Surat, PIN: 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, PIN: 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 
Dr Deepti Yesade  C. D. Pachchigar college of homoeopathic medicine and hospital  Department of Psychiatry,C. D. Pachchigar college of homoeopathic medicine and hospital, near anand mangal society, Udhana Magdalla road, Surat
Surat
GUJARAT 
9403803599

deepti.yesade81@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: F91||Conduct disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic Medicine  Homoepathic medicines in Centicimal potencies as per requirement of cases via oral route, repetition is as per requirement of case and susceptibility of patient. Duration of intervention would be 3 to 6 months. 
Comparator Agent  not applicable  not applicable 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  GENETIC CONSTITUTE: genetically normal developed individuals.
Economical class: Patients of all economical class would be included.
DIAGNOSIS: subjects who meet DSM 5 TR criteria for behavioural
disorders of children mentioned in respective diseased condition.  
 
ExclusionCriteria 
Details  AGE: children below 5 years and above 16 years, or diagnosed after
the age of 12 years.
GENETIC CONSTITUTE: individuals with genetically maldeveloped
conditions.
OTHER DISEASED CONDITIONS: subjects with other
neurodevelopmental disorders will be excluded. Subjects with
behavioural disorders whose symptoms are better explained by other
systemic diseases will be excluded.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Homoeopathic medicines do not have any effect on behavioural disorders pf children.   6 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
homoeopathic medicines have effect on behavioural disorders of children.  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)   01/02/2025 
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:

It is crucial to understand and research behavioural disorders in children for several reasons. This includes the child’s overall well-being, family dynamics, and the broader impact on society.

Impact on Child Growth:

·       Behavioural disorders can seriously affect a child’s mental, emotional, and social growth.

·       Examining the causes these disorders and spotting them early is vital to put in place interventions that can help a child develop positively.

Family Relationships:

·       Behavioural disorders often bring stress to families.

·       Studying these disorders helps us come up with ways to support families better and improve.

School Challenges:

·       Behavioural disorders can make it tough for children to learn and do well in school.

·       Research helps create tools and programs that can support kids with behavioural disorders in their education.

Public Well-being:

·       Behavioural disorders in childhood have long-lasting effects on mental health.

·       Finding effective ways to prevent and manage these disorders benefits public mental health and lessens the impact on society.

Early Help:

·       Spotting behavioural disorders early means we can step in and help before things get worse.

·       Research guides the development of tools and programs to catch and address behavioural issues early on.

Training for Parents and Teachers:

·       Parents and teachers are key in supporting kids with behavioural disorders.

·        Research helps create training programs for them, giving them the tools and knowledge to manage and support affected children.

Reducing Stigma:

·       Research helps us understand the various factors contributing to behavioural disorders, reducing the stigma around them.

·       Being more aware helps us be more understanding and supportive of individuals and families dealing with these conditions.

6.2

REVIEW OF LITRATURE:

 

To quote the American Psychology Association, behavioural disorders are any persistent and repetitive pattern of behavior that violates societal norms or rules, seriously impairs a person’s functioning, or creates distress in others. The term is used in a very general sense to cover a wide range of disorders or syndromes. Also called behavioral disorder. (1)

In the context of children, common behavioural disorders include conduct disorders, oppositional defiant disorder, the hyperactivity type of Attention-Deficit/Hyperactivity Disorder (ADHD), disruptive behaviour disorders, and certain forms of obsessive-compulsive disorders. These disorders can manifest in various ways, impacting a child’s daily life and interactions. Recognising and understanding such behavioural disorders is crucial for effective intervention and support to enhance the well-being of the individuals involved.

 

Having some degree of problem behaviour is normal for most children and adolescents. It can be a normal part of growing. Only children and adolescents with a moderate to severe degree of psychological, social, educational or occupational impairment in multiple settings should be identified as having behavioural disorders. Community studies have identified that more than 80% of pre-schoolers have mild tantrums sometimes but a smaller proportion, less than 10% will have daily tantrums, regarded as normative misbehaviours at these Challenging behaviours and emotional difficulties are more likely to be recognized as "problems" rather than "disorders" during the first 2 years of life. (2)

 

Challenging behaviours has been defined as: “Culturally abnormal behaviour (s) of such an intensity, frequency or duration that the physical safety of the person or others is likely to be placed in serious jeopardy or behaviour which is likely to seriously limit or deny access to and use of ordinary community facilities”. (3)

 

Aggression is a common, yet complex, challenging behaviour, and a frequent indication for referral to child and adolescent Psychiatrists. It commonly begins in childhood, with more than 58% of preschool children demonstrating some aggressive behaviour. Aggression has been linked to several risk factors, including individual temperaments; the effects of disturbed family dynamics; poor parenting practices; exposure to violence and the influence of attachment disorders. No single factor is sufficient to explain the development of aggressive behaviour. Aggression is commonly diagnosed in association with other mental health problems including ADHD, CD, ODD, depression, head injury, mental retardation, autism, bipolar disorder, PTSD, or dyslexia. (3)

 

ADHD is a neuropsychiatric condition affecting preschoolers, children,

adolescents, and adults around the world, characterized by a pattern of

diminished sustained attention, and increased impulsivity or hyperactivity. (4)

 

In DSM-5, subtypes have been replaced by the following three specifiers, which largely denote the same groups: 1. combined presentation, 2. predominantly inattentive presentation, and 3. predominantly hyperactive/impulsive presentation. (5)

 

Oppositional defiant disorder describes enduring patterns of negativistic, disobedient, and hostile behavior toward authority figures, as well as an inability to take responsibility for mistakes, leading to placing blame on others. (4)

 

Children with conduct disorder engage in severe, repeated acts of aggression that can cause physical harm to themselves and others and frequently violate the rights of others. (4)

 

In a study conducted by Dr. Justina M Steefan et al. in the International Journal of Homoeopathic Sciences (2023, Vol. 7 Issue 1, Part H), the authors underscore the efficacy of homoeopathy in treating paediatric patients with common behavioural disorders. The study emphasizes the success of homoeopathic interventions in managing disorders such as ADHD, ODD, and Conduct Disorder, showcasing the potential of homoeopathy in addressing the distinctive features of these disorders. (6)

 

A study by Shamsah Jamal and PR Sisir (International Journal of Homoeopathic Sciences, 2022, Vol. 6 Issue 4, Part A) investigates the management of ADHD-related behaviours in children using homoeopathic medicines selected based on prenatal maternal mental states. The study not only explores the effectiveness of homoeopathic intervention in improving ADHD-related behaviours but also delves into the analysis of maternal prenatal mental states contributing to the pathogenesis of ADHD. This study highlights the importance of considering the prenatal period in managing ADHD through homoeopathic treatment. (7)

 

Dr. Ankit Dubey and Dr. Bainu Sharma, in their prospective observational study (International Journal of Homoeopathic Sciences, 2022, Vol. 6 Issue 3, Part C), contribute valuable insights into the role of an individualized homoeopathic approach in managing ADHD. The study, focusing on children aged 5-12, emphasizes the principles of individualization in prescribing homoeopathic medicines. Results indicate significant improvement in ADHD symptoms, reinforcing the potential of homoeopathy in addressing neurobehavioral disorders in children. (8)

 

a case series conducted by Deepthi Gilla et al. (2023, Vol. 22, Homoeopathy for Reducing Disruptive Behavioural Symptoms in Children with Conduct Disorder: A Case Series. International Journal of High Dilution Research, 22(cf), 39–50) focuses on the effectiveness of individualized homoeopathic medicines in reducing disruptive behavioural symptoms in children diagnosed with Conduct Disorder. The study highlights a marked reduction in disruptive behaviour and an improvement in the general condition of the children, presenting preliminary evidence for the usefulness of homoeopathic interventions in the management of CDs. (9)

 

These studies collectively suggest that homoeopathy holds promise in the management of behavioural disorders in children. The individualized approach, consideration of prenatal factors, and integration with auxiliary therapies emerge as key aspects contributing to the success of homoeopathic interventions. However, further research and clinical trials are warranted to solidify the evidence base and establish homoeopathy as a credible therapeutic option for paediatric behavioural disorders.

6.3

OBJECTIVES OF STUDY

1.               Assess the impact of homoeopathic management on paediatric behavioural disorders.

2.               To identify individual and environmental factors that significantly contribute to the risk and development of behavioural disorders in children.

3.               To explore the Impact of Early Intervention Strategies on Behavioural Disorders in Children.

 


 

7

MATERIALS AND METHODS

7.1

SOURCE 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

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.

Case Performa of C. D. Pachchigar general hospital.

Consent form of patient.

7.3

METHOD OF COLLECTION OF DATA:

v Study type: clinical.

v Study design: Experimental. 

v Study population: children from OPD of C. D. Pachchigar Homoeopathic Hospital and from peripheral OPDs. 

v Sample size: 30 patients. 

v Sample techniques: simple random sampling. 

v Study duration: 9 months.

v Inclusion criteria: 

Ø  AGE: Between 5 to 16 years.

Ø  SEX: Both sexes. 

Ø  GENETIC CONSTITUTE: genetically normal developed individuals.  

Ø  Economical class: Patients of all economical class would be included.

Ø  DIAGNOSIS: subjects who meet DSM 5 TR criteria for behavioural disorders of children mentioned in respective diseased condition. 

v Exclusion criteria: 

Ø  AGE: children below 5 years and above 16 years, or diagnosed after the age of 12 years.

Ø  GENETIC CONSTITUTE: individuals with genetically maldeveloped conditions. 

Ø  OTHER DISEASED CONDITIONS: subjects with other neurodevelopmental disorders will be excluded. Subjects with behavioural disorders whose symptoms are better explained by other systemic diseases will be excluded. 

v Data analysis and methods:

Ø  Improved: Subjects showing a clinically marked increase in good behavioural control and clinically significant improvement in personal, social and academic life. Children showing improvement in respected psychological scoring scales. Patients with increased periods of remission. 

Ø  Not Improved: no clinically favourable behavioural improvement after medicinal interventions. Children 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.

 


 

8.

BIBILOGRAPHY

1.

APA DoP. American Psychological Association. [Online].; 2018 [cited 2024 JANUARY 2nd. Available from: https://dictionary.apa.org/behavior-disorder.

2.

Organization WH. National Center for Biotechnology Information (NCBI). [Online].; 2016 [cited 2024 January 16. Available from: https://www.ncbi.nlm.nih.gov/books/NBK390829/.

3.

MO O. World Journal of Clinical Pediatrics. [Online].; 2018 [cited 2024 January 17. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5803568/#:~:text=Mental%20health%20disorders%20(MHD)%20are,(speech%2Flanguage%20delay%2C%20intellectual.

4.

Benjamin James Sadock VASPR. Kaplan & Sadock’s Synopsis of Psychiatry. 12th ed. Marcia L. Verduin RJB, editor. China: Lippincott Williams & Wilkins; 2021.

5.

Association AP. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). Fifth Edition ed. Arlington, VA: American Psychiatric Association; 2013.

6.

Justina M Steefan D,SGDLMPMSSNS. International Journal of Homoeopathic Sciences. [Online].; 2023 [cited 2024 january 14. Available from: https://doi.org/10.33545/26164485.2023.v7.i1h.790.

7.

Shamsah Jamal PS. International Journal of Homoeopathic Sciences. [Online].; 2022 [cited 2024 January 5. Available from: https://doi.org/10.33545/26164485.2022.v6.i4a.635.

8.

Ankit Dubey D,BS. International Journal of Homoeopathic Sciences. [Online].; 2022 [cited 2023 December 27. Available from: https://doi.org/10.33545/26164485.2022.v6.i3c.610.

9.

Deepthi Gilla MNKSNKaSNK. International Journal of High Dilution Research. [Online].; 2023 [cited 2024 January 21. Available from: https://www.highdilution.org/index.php/ijhdr/article/view/1273.

 

 


 
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