| CTRI Number |
CTRI/2025/08/092979 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Testing If Personalized Homoeopathic Treatment Can Help People With Long Term Anxiety |
|
Scientific Title of Study
|
A study on the effectiveness of Individualised Homoeopathic medicine in treating of Generalised Anxiety Disorder assessed using Hamilton anxiety scale |
| 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 Ajitha I |
| Designation |
Pg Scholar |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
Room Number 513
4th floor
Department of Psychiatry
Sarada Krishna Homoeopathic Medical College
kulasekharam
kanniyakumari
Kanniyakumari TAMIL NADU 629161 India |
| Phone |
7358833900 |
| Fax |
|
| Email |
ajithaiyyathurai@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Diana R |
| Designation |
Associate Professor and Head Department of Psychiatry |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
Room Number 510
4th floor
Department of Psychiatry
Sarada Krishna Homoeopathic Medical College
kulasekharam
kanniyakumari
Kanniyakumari TAMIL NADU 629 161 India |
| Phone |
9663475174 |
| Fax |
|
| Email |
dr.diana.r@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Diana R |
| Designation |
Associate Professor and Head Department of Psychiatry |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
Room Number 510
4th floor
Department of Psychiatry
Sarada Krishna Homoeopathic Medical College
kulasekharam
kanniyakumari
Kanniyakumari TAMIL NADU 629 161 India |
| Phone |
9663475174 |
| Fax |
|
| Email |
dr.diana.r@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institution sarada Krishna homoeopathic medical college
Kulasekharam
kanniyakumari
Tamilnadu 629161 |
|
|
Primary Sponsor
|
| Name |
Post graduate research funded by sarda Krishna homoeopathic medical college |
| Address |
Sarda Krishna homoeopathic medical college
Kulasekharam
Kanniyakumari
Tamilnadu 629161
Kanyakumari
Tamilnadu 629161 |
| 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 Ajitha I |
Sarada Krishna homoeopathic medical college |
Room number 513
4th floor
Department of Psychiatry
Sarada Krishna homoeopathic medical college
Kulasekharam
Kanniyakumari TAMIL NADU |
7358833900
ajithaiyyathurai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sarada Krishan Homoeopathic Medical College Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F411||Generalized anxiety disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised Homoeopathic Medicine |
Patients present with symptoms 0f generalised anxiety disorder will be screened and diagnosed according to ICD-10.
Patient will receive homoeopathic treatment to the symptom and individualised based.
Medicine will be based on totality of symptom.
Patient will be followed up at regular interval (monthly) for a specific 1year duration to monitor treatment progress and assess outcome measures.
The patient is assessed with HAMILTON ANXIETY RATING SCALE for knowing the severity of generalized anxiety disorder before homeopathic intervention.
|
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with generalised anxiety disorder according to ICD 10 criteria |
|
| ExclusionCriteria |
| Details |
Patients with comorbid psychiatric disorders requiring immediate attention (e.g., psychosis, severe depression, bipolar disorder)
Patients with a history of substance abuse
Those unable to understand or comply with the study procedures
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Primary outcome measure will be the change in scores on the Hamilton Anxiety Rating scale |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The change in scores on the Hamilton Anxiety Rating scale from baseline to the end of the study. Assessment is done every month of medications and the case is followed up to a period of 1 year |
1 year |
|
|
Target Sample Size
|
Total Sample Size="28" Sample Size from India="28"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/08/2025 |
| 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="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Generalised anxiety disorder (GAD) is a mental and behavioural disorder. Which is characterised by excessive anxiety and worry, which is very difficult to control together with impaired physical, social, occupational or other areas of functioning. Persons with generalised anxiety disorder are anxious and worried about almost everything in their life There is a need to identify and treat generalised anxiety disorder patients in order to cause significant distress or impairment in personal, family, social, educational, occupational, or other important areas of functioning The interventions used will vary for every patient as we are administering individualized homeopathic medicine in generalized anxiety disorder to improve outcomes and a better quality of life for those disorders. PROCEDURE Medicine will be based on totality of symptom Patient will be followed up at regular interval (monthly) for a specific duration to monitor treatment progress and assess outcome measures The patient is assessed with HAMILTON ANXIETY RATING SCALE for knowing the severity of generalized anxiety disorder before homeopathic intervention. OUTCOME The primary outcome measure will be the change in scores on the Hamilton Anxiety Rating scale (HAM-A) from baseline to the end of the study. Assessment is done every month of medications and the case is followed up to a period of 1 year. |