| CTRI Number |
CTRI/2025/07/091335 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Understanding And Management Of Disruptive Mood Dysregulation Disorder In Primary School Going Children With Homoeopathy |
|
Scientific Title of Study
|
Study On Disruptive Mood Dysregulation Disorder In Primary 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 |
Mansi Bharatbhai Narola |
| Designation |
PG Scholar |
| Affiliation |
C D Pachchigar College of Homoeopathic Medicine and Hospital |
| Address |
Department Of Psychiatry Post Graduation Division 2nd Floor C D Pachchigar College of Homoeopathic Medicine and Hospital Near Navjivan Circle Udhana Magdalla Road Surat
Surat
GUJARAT
395001
India |
| Phone |
7285087548 |
| Fax |
|
| Email |
mansinarola77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Bhatia |
| Designation |
Assistant Professor |
| Affiliation |
C D Pachchigar College of Homoeopathic Medicine and Hospital |
| Address |
Department Of Psychiatry Post Graduation Division 2nd Floor C D Pachchigar College of Homoeopathic Medicine and Hospital Near Navjivan Circle Udhana Magdalla Road Surat
Surat
GUJARAT
395001
India |
| Phone |
9033111464 |
| Fax |
|
| Email |
sunstarhc2012@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arun Bhatia |
| Designation |
Assistant Professor |
| Affiliation |
C D Pachchigar College of Homoeopathic Medicine and Hospital |
| Address |
Department Of Psychiatry Post Graduation Division 2nd Floor C D Pachchigar College of Homoeopathic Medicine and Hospital Near Navjivan Circle Udhana Magdalla Road Surat
Surat
GUJARAT
395001
India |
| Phone |
9033111464 |
| Fax |
|
| Email |
sunstarhc2012@gmail.com |
|
|
Source of Monetary or Material Support
|
| C D Pachchigar College of Homoeopathic Medicine and Hospital Near Navjivan Circle Udhana Magdalla Road Surat India 395001 |
|
|
Primary Sponsor
|
| Name |
C D Pachchigar College of Homoeopathic Medicine and Hospital |
| Address |
C D Pachchigar College of Homoeopathic Medicine and Hospital Near Navjivan Circle Udhana Magdalla Road Surat |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mansi Bharatbhai Narola |
C D Pachchigar College of Homoeopathic Medicine and Hospital |
Department Of Psychiatry Post Graduation Division 2nd Floor C D Pachchigar College of Homoeopathic Medicine and Hospital near Navjivan circle Udhana Magdalla road Surat 395001 Gujarat India
Surat
GUJARAT |
7285087548
mansinarola77@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F34||Persistent mood [affective] disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicines |
Individualized Homoeopathic Medicine and its dose potency and frequency of repetition will be prescribed on the basis of totality of symptoms and individual susceptibility The medicine will be administered orally within time duration of 9 months |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Patients of all economical class
Genetically normal developed individuals
Patients who meet DSM 5 criteria for Disruptive mood
dysregulation disorder |
|
| ExclusionCriteria |
| Details |
Age below 6 years and above 10 years
Individuals with genetically maldeveloped
conditions
Individuals on any psychiatric medications
Other disorders like
Oppositional defiant disorder, Intermittent explosive disorder, or Bipolar
disorder or any systemic disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess the role of homoeopathy in children with Disruptive mood dysregulation disorder |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To identify individual and environmental factors that significantly
contribute to the risk and development of Disruptive mood dysregulation disorder in 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)
|
01/08/2025 |
| 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: It is crucial to understand and research Disruptive Mood Dysregulation Disorder (DMDD) in children for several reasons. This includes the child’s overall well-being, family dynamics, and the broader impact on society. DMDD can seriously affect a child’s mental, emotional, academic and social growth. So, examining the causes of these disorder and spotting them early is vital for positive growth of child as an adult.
DMDD often bring stress to families i.e. Studying these disorder helps us come up with ways to support families better and improve.
DMDD can make it tough for children to learn and do well in school. Research helps to create tools and programs for better education of children.
DMDD in childhood have marked effects on mental health as an adult. Finding effective ways to prevent and manage this disorder is beneficial for public mental health and create better impact on society.
Parents and teachers are key in supporting kids with DMDD. Research helps awareness to them regarding the disorder and supporting children.
INTRODUCTION: Disruptive Mood Dysregulation Disorder (DMDD) (ICD10 – F34.81) was introduced as a new diagnosis in the 5th edition of the Diagnostic and Statistical Manual (DSM-5). The core feature of DMDD is chronic, severe persistent irritability accompanied by severe temper outbursts, at least 3 times per week, that are out of proportion to provocation and inconsistent with the patient’s developmental level.
HOMOEOPATHIC MANAGEMENT: Homoeopathy is one of the most suitable options for managing behavioral disorders, as they have a significant emotional component. Mainly, aphorisms 215, 221, 224 and 225 pertain to the various types of mental illnesses that Dr Hahnemann perceived.
OBJECTIVE OF STUDY: To reduce recurrent episodes and chances of comorbidities.
SOURCE OF DATA: O.P.D and I.P.D of C.D. PACHCHIGAR Homoeopathic college & hospital.
DATA ANALYSIS AND METHODS: Improved: Subjects showing a clinically marked increase in good irritability control and clinically significant improvement in personal, social and academic life. Not Improved: No clinically favorable improvement after medicinal interventions. Children with aggravated scores in their respective scoring scales. Left the treatment: subjects who will not maintain follow-ups till advised to discontinue treatment. |