| 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
|
|
|
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
|
|
|
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. |