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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  
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 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  
Status 
Not Applicable 
 
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.

 
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