| CTRI Number |
CTRI/2025/11/097630 [Registered on: 18/11/2025] Trial Registered Prospectively |
| Last Modified On: |
18/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy
Behavioral |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Study to compare effect of Homoeopathic medicines given along with Cognitive Behavioural Therapy for Attention Deficit Hyperactive Disorder in adults |
|
Scientific Title of Study
|
A study on the efficacy of Individualized Homoeopathic Medicines combined with Cognitive Behavioural Therapy in Adult ADHD |
| 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 Soubhagya S S |
| Designation |
Junior Resident, Department of Organon of Medicine |
| Affiliation |
White Memorial Homoeo Medical College and Hospital |
| Address |
Department of Organon of Medicine, White Memorial Homoeo Medical College and Hospital, Attoor, Veeyanoor PO, Kanniyakumari
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9074552100 |
| Fax |
|
| Email |
soubhagyasoubhagam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indu P |
| Designation |
Head of Department, Professor |
| Affiliation |
White Memorial Homoeo Medical College and Hospital |
| Address |
Department of Organon of Medicine, White Memorial Homoeo Medical College and Hospital, Attoor, Veeyanoor PO, Kanniyakumari
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9495704030 |
| Fax |
|
| Email |
indusujan9495@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Indu P |
| Designation |
Head of Department, Professor |
| Affiliation |
White Memorial Homoeo Medical College and Hospital |
| Address |
Department of Organon of Medicine, White Memorial Homoeo Medical College and Hospital, Attoor, Veeyanoor PO, Kanniyakumari
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9495704030 |
| Fax |
|
| Email |
indusujan9495@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Organon of Medicine, White Memorial Homoeo Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Department of Organon of Medicine, White Memorial Homoeo Medical College and Hospital |
| Address |
White Memorial Homoeo Medical College and Hospital, Attoor, Veeyanoor PO Kanniyakumari, Tamil Nadu 629177 |
| 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 Soubhagya SS |
White Memorial Homoeo Medical College and Hospital |
Department of Organon of Medicine, White Memorial Homoeo Medical College and Hospital Attoor Veeyanoor PO Kanniyakumari 629 177
Kanniyakumari
TAMIL NADU |
9074552100
soubhagyasoubhagam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| WHITE MEMORIAL HOMOEO MEDICAL COLLEGE & HOSPITAL ETHICS COMMITTEE WMHMC-EC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F90-F98||Behavioral and emotional disorders with onset usually occurring in childhood and adolescence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cognitive Behavioural Therapy |
Cognitive Behavioural Therapy will be administered through structured monthly sessions focusing on organization skills, emotional regulation and coping strategies following standard therapeutic guidelines for Adult ADHD. Total duration of intervention is 1 year. |
| Intervention |
Individualized Homoeopathic Medicine |
Case taking, selection and administration of medicine will be according to the Homoeopathic principles. Analysed cases will be repertorised and suitable medicine will be selected according to susceptibility of the patient. Follow up will be done once a month. Total duration of intervention is 1 year. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Adults between the ages 18 to 45 years
Diagnosis of ADHD or positive screening on ASRS v1 1
Willingness to undergo either homeopathic treatment or with CBT
Ability to provide informed consent
Able to participate in follow-up over 12 months.
|
|
| ExclusionCriteria |
| Details |
Age below 18 and above 45.
Presence of major psychiatric disorders (bipolar disorder, schizophrenia).
Autism spectrum disorder (ASD) (unless ADHD symptoms are clearly present and separate).
Currently under pharmacological treatment for ADHD.
Current substance dependence.
Unwillingness or inability to commit to follow-up.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in total ADHD symptom severity scores (Quantified ASRS) from baseline to 12 months. |
Assessment is done at beginning of study, at 6th month and at 12th month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Quality of life score assessed by WHOQOL- BREF scale. |
Assessment is done at beginning of study and at 12th month. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/12/2025 |
| 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="1"
Months="0"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - All data will be provided when needed through email soubhagyasoubhagam@gmail.com
- For how long will this data be available start date provided 01-01-2028 and end date provided 01-01-2035?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Attention-deficit/hyperactivity disorder
(ADHD), a neurodevelopmental disorder was first identified in children but is now more widely acknowledged in
adults. Risks of untreated ADHD may result in difficulties with impulse control,
attention, and executive functions, impacting various aspects of an
individual’s life. Adult ADHD symptoms are similar to those of
childhood ADHD, albeit over time, the severity of some symptoms, particularly
hyperactivity, may lessen. There is a lack of scientific research on
psychosocial treatments, however there is some initial evidence that cognitive behavioural
therapy and medicine work well together. Cognitive Behavioural Therapy
(CBT) is evidence-based and effective in improving coping mechanisms,
emotional control, and functional skills. The long-term use of
pharmacological agents may be associated with side effects, dependency
concerns, and poor adherence. The need to investigate safe,
cost-effective, and integrative treatment options that improve quality of life
and functional outcomes is urgent, given the growing number of adults
experiencing symptoms of ADHD and the shortcomings of pharmaceutical treatments. A potentially comprehensive
and patient-centred strategy is provided by combining homeopathy with
structured Cognitive Behavioural Therapy. Through the
use of standardized instruments (such as the ASRS v1.1) and a scientifically
sound format, this study seeks to close a substantial research gap by comparing
the efficacy of individualized homeopathic treatment with CBT. This study will evaluate whether homeopathy can effectively manage ADHD in
addition to or instead of traditional treatment by comparing changes in symptom
severity over a 12-month period. The study also aims to compare Quality of life before and after the study using WHOQOL- BREF Scale. |