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CTRI Number  CTRI/2022/10/046584 [Registered on: 18/10/2022] Trial Registered Prospectively
Last Modified On: 17/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Effectiveness of homoeopathy in specific phobia 
Scientific Title of Study   THE EFFECTIVENESS OF INDIVIDUALIZED HOMOEOPATHIC MEDICINE IN SPECIFIC PHOBIA 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jinu M Sunil 
Designation  Post graduate scholar 
Affiliation  Kerala University of Health Sciences 
Address  Department of Psychiatry National Homoeopathy Research Institute in Mental Health,Sachivothamapuram ,Kurichy,Kottayam

Kottayam
KERALA
686532
India 
Phone  7736786632  
Fax    
Email  drjinumsunil@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr DHANARAJ KUMAR RANA 
Designation  ASSISTANT PROFESSOR 
Affiliation  Kerala University of Health Sciences 
Address  Department of Psychiatry National Homoeopathy Research Institute in Mental Health,Sachivothamapuram, Kurichy,Kottayam

Kottayam
KERALA
686532
India 
Phone  9496470061  
Fax    
Email  drdkrana123@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr DHANARAJ KUMAR RANA 
Designation  ASSISTANT PROFESSOR 
Affiliation  Kerala University of Health Sciences 
Address  Department of Psychiatry National Homoeopathy Research Institute in Mental Health,Sachivothamapuram ,Kurichy,Kottayam

Kottayam
KERALA
686532
India 
Phone  9496470061  
Fax    
Email  drdkrana123@gmail.com  
 
Source of Monetary or Material Support  
NATIONAL HOMOEOPATHY RESEARCH INSTITUTE IN MENTAL HEALTH, KURICHY,KOTTAYAM 
 
Primary Sponsor  
Name  Dr JINU M SUNIL 
Address  POST GRADUATE SCHOLAR DEPARTMENT OF PSYCHIATRY NATIONAL HOMOEOPATHY RESEARCH INSTITUTE IN MENTAL HEALTH , SACHIVOTHAMAPURAM,KURICHY,KOTTAYAM,686532  
Type of Sponsor  Other [SELF] 
 
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 Jinu M Sunil  National Homoeopathy Research Institute In Mental Health  Department of Psychiatry National Homoeopathy Research Institute in Mental Health,Sachivothamapuram ,Kurichy,Kottayam
Kottayam
KERALA 
7736786632

drjinumsunil@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F402||Specific (isolated) phobias,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  HOMOEOPATHIC MEDICINES  Individualized Homoeopathic medicines prescribed on the basis of homoeopathic principles. Dose: according to homoeopathic principles Frequency: According to homoeopathic principles Route: oral. enrollment :6 month Intervention: 1 year  
Comparator Agent  Nil   Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Cases satisfying specific phobia (F40.2) diagnostic criteria of ICD 10, Age group between 18 to 65 years.
 
 
ExclusionCriteria 
Details  Cases with life-threatening Systemic illness, Cases with comorbid major psychiatric conditions, Subjects who are pregnant or lactating, Subjects who are under psychotropic medications. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the change in the intensity of specific phobia after individualized
homoeopathic medicine 
6 months for enrollment. One year for follow-up and intervention. 
 
Secondary Outcome  
Outcome  TimePoints 
To find out the change in quality of life of patients with specific phobia after
homoeopathic medicines. 
6 months for enrollment. One year for follow-up and intervention. 
 
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   Phase 3 
Date of First Enrollment (India)   21/10/2022 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Aim: 

 To find out the effectiveness of individualized homoeopathic medicine in reducing symptoms of specific phobia. 

Primary Objective: 

 To determine the change in the intensity of specific phobia after individualized homoeopathic medicine. 

Secondary objective

 To find out the change in quality of life of patients with specific phobia after homoeopathic medicines.

 HYPOTHESIS 

 Null Hypothesis (H0)

 Homoeopathic remedies are not effective in reducing symptoms of specific phobia 

Alternative Hypothesis (H1) 

 Homoeopathic remedies are effective in reducing symptoms of specific phobia

METHODS OF DATA COLLECTION AND OUTCOME MEASUREMENT 

All patients who present with fear, anxiety, and avoidance of certain situations at outpatient department of National Homoeopathy Research Institute in Mental Health, Kottayam & peripheral OPDs shall be screened with a preliminary verbal screening by OPD doctors followed by detailed screening by the investigator. After screening, the Psychiatrist will assess the case for diagnostic confirmation. Written informed consent will be taken from each subject. Basic routine investigations will be done at baseline. Appropriate investigations must be done to rule out other symptoms when required. Detailed case taking will be done on the case recording format made for the study. Cases will be assessed by using SEVERITY MEASURE FOR SPECIFIC PHOBIA - ADULT SCALE at baseline and at periodic intervals during monthly follow-ups. WHO QOL questionnaire will be assessed at baseline & every 6 months of the study. Individual totality will be erected on the basis of analysis and evaluation of the case. Repertorisation will be done with synthesis repertory using RADAR OPUS software version. Final selection of remedy will be done after comparison with Homoeopathic Materia Medica. The dose and repetition of medicine will be done based on Homoeopathic principles. The progress will be assessed for a period of 1 month. If improvement stops at a period, next higher potency will be given. If no change takes place at all, the case will be retaken and another remedy will be considered. If any acute complaints arise, acute totality will be taken and the appropriate remedy will be administered. If there are no follow-ups for 3 consecutive visits, telephonic follow-up will be done and if they are not responding or in the absence of further visit the case will be considered as dropped out. The drop out cases if returning for treatment will be given standard care but will not be included in the study. Those who have willingly withdrawn from the study also will be given general treatment in OPD but not considered for the study evaluation. The study will be conducted after the approval from institutional ethical committee and after registration in CTRI.
 
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