| CTRI Number |
CTRI/2026/02/104202 [Registered on: 18/02/2026] Trial Registered Prospectively |
| Last Modified On: |
17/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
To study the effectiveness of Homoeopathic treatment in children with Separation anxiety disorder |
|
Scientific Title of Study
|
A clinical study to assess the effectiveness of individualized Homoeopathic medicines in the treatment of Separation anxiety disorder in children using the scared questionnaire |
| 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 Madineni Manasa |
| Designation |
PG Scholar |
| Affiliation |
Dr B D Jatti Homoeopathic Medical College Hospital and PG Research Centre |
| Address |
Dr B D Jatti Homoeopathic Medical College Hospital and PG Research Centre DC Compound Dharwad
Dharwad
KARNATAKA
580001
India |
| Phone |
9606550760 |
| Fax |
|
| Email |
madinenimanasa26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monika Katti |
| Designation |
Professor |
| Affiliation |
Dr B D Jatti Homoeopathic Medical College Hospital and PG Research Centre |
| Address |
Dr B D Jatti Homoeopathic Medical College Hospital and PG Research Centre DC Compound Dharwad
Dharwad
KARNATAKA
580001
India |
| Phone |
9448530508 |
| Fax |
|
| Email |
monikakatti49183@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madineni Manasa |
| Designation |
PG Scholar |
| Affiliation |
Dr B D Jatti Homoeopathic Medical College Hospital and PG Research Centre |
| Address |
Dr B D Jatti Homoeopathic Medical College Hospital and PG Research Centre DC Compound Dharwad
Dharwad
KARNATAKA
580001
India |
| Phone |
9606550760 |
| Fax |
|
| Email |
madinenimanasa26@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Madineni Manasa
Dr BD Jatti Homoeopathic Medical College Hospital and PG Research Centre DC Compound Dharwad 580001 |
|
|
Primary Sponsor
|
| Name |
Dr Madineni Manasa |
| Address |
Dr BD Jatti Homoeopathic Medical College Hospital and PG Research Centre DC Compound Dharwad 580001 |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
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 Madineni Manasa |
Dr BD Jatti Homoeopathic Hospital Dharwad |
Dept of Organon of medicine Medicine division Opd no 1
Dr BD Jatti Homoeopathic Medical College Hospital and PG Research Centre Dharwad
Dharwad
KARNATAKA |
9606550760
madinenimanasa26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr B D Jatti Homoeopathic Medical College Hospital and PG Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F930||Separation anxiety disorder of childhood, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
All subjects will be followed up every 2 weeks and as per the need of each case for a period of 24 weeks
Medicine will be administered orally
Dose and potency are selected as per the susceptibility of each subject |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Subjects whose parents have signed the written consent and are willing to participate voluntarily.
Subjects satisfying the diagnostic criteria of Separation Anxiety Disorder according to DSM-5.
Subjects whose SCARED Questionnaire score for Separation Anxiety Disorder is greater than 5.
|
|
| ExclusionCriteria |
| Details |
Subjects suffering with any other mental disorders like generalized anxiety disorder, psychotic disorders and agoraphobia.
Subjects on active treatment for other systemic diseases.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in SCARED questionnaire score for Separation Anxiety Disorder |
From baseline to the end of 6 months of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in clinical symptoms of Separation Anxiety Disorder |
The follow-up of the cases would be done based on individual case preferably initially once in 15 days for a period of 6 months |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
28/02/2026 |
| 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="1"
Months="6"
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
|
The most prevalent mental illnesses among children are anxiety disorders, which are frequently overlooked. One of the most common childhood anxiety disorders to be diagnosed is Separation Anxiety Disorder. According to the DSM-5, Separation Anxiety Disorder is a level of fear or anxiety regarding separation from their parents or primary caregiver that is beyond developmental expectations. The DSM-5 criteria require the presence of at least three symptoms related to excessive worry about separation from a significant attachment figure for at least 4 weeks. The worries often take the form of refusal to go to school, fears, and distress on separation, repeated complaints of physical symptoms such as headaches and stomach aches when anticipating separation, and nightmares related to separation issues. Independent activities away from home or attachment figures are frequently restricted by them. Separation Anxiety Disorder is a pervasive disorder of childhood. Without proper diagnosis and intervention, a child may suffer from many negative effects including short-term educational and emotional or behavioral problems as well as long-term effects spanning into adulthood. So, with this high prevalence rate and negative impact on the quality of life of a child, this condition poses a great public and academic challenge. Homoeopathy treats an individual with a disease rather than a disease in an individual. It has a dynamic, holistic and individualistic approach to treating sickness. A remedy prescribed on the basis of Homoeopathic principles can effectively treat the sick. Modern medicine has now come to an understanding that disturbed mental health can produce physical manifestations, but Dr. Hahnemann described it many years ago in the Organon of Medicine under aphorism 225. Hence, here is a study to assess the effectiveness of individualized Homoeopathic medicines in the treatment of Separation Anxiety Disorder using the SCARED Questionnaire. NULL HYPOTHESIS: Homoeopathic medicines are not effective in the treatment of Separation Anxiety Disorder. RESEARCH HYPOTHESIS: Homoeopathic medicines are effective in the treatment of Separation Anxiety Disorder. ALTERNATIVE HYPOTHESIS: Homoeopathic medicines may be effective in the treatment of Separation Anxiety Disorder. |