| CTRI Number |
CTRI/2024/07/069709 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to understand role of homoeopathic medicine in treating adult person with adjustment problem |
|
Scientific Title of Study
|
A Prospective study on the effectiveness of homoeopathic medicine in managing of Adjustment disorder assessed using the Adjustment disorder new module 20 |
| 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 JENIFA S |
| Designation |
PG Scholar |
| Affiliation |
Sarada krishna homoeopathic medical college |
| Address |
4th floor, Department of psychiatry,Sarada Krishna homoeopathic medical college,Kulasekharam,Kanniyakumari district,Tamilnadu,pin-629161
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
8015197014 |
| Fax |
|
| Email |
dr.jenifaselvaraj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR DIANA R |
| Designation |
Associate professor and Head of the Department |
| Affiliation |
Sarada krishna homoeopathic medical college |
| Address |
4th floor, Department of psychiatry,Sarada Krishna homoeopathic medical college,Kulasekharam,Kanniyakumari district,Tamilnadu,pin-629161
Kanniyakumari
TAMIL NADU
629161
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 of the Department |
| Affiliation |
Sarada krishna homoeopathic medical college |
| Address |
4th floor, Department of psychiatry,Sarada Krishna homoeopathic medical college,Kulasekharam,Kanniyakumari district,Tamilnadu,pin-629161
TAMIL NADU
629161
India |
| Phone |
9663475174 |
| Fax |
|
| Email |
dr.diana.r@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institution-Sarada krishna homoeopathic medical college,Kulasekharam,Kanniyakumari district,Tamilnadu,India,pin-629161 |
|
|
Primary Sponsor
|
| Name |
Post graduate research funded by college |
| Address |
Sarada krishna homoeopathic medical college,kulasekharam,Kanniyakumari district,tamilnadu,pin-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 Jenifa S |
Sarada krishna homoeopathic medical college |
Department of Psychiatry,Room no.510Sarada krishna homoeopathic medical college,Kulasekhram,Kanniyakumari district,Tamilnadu,pin-629161
Kanniyakumari
TAMIL NADU |
8015197014
dr.jenifaselvaraj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE SARADA KRISHNA HOMOEOPATHIC MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F432||Adjustment disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Individualized Medicine |
Selection of cases with the symptoms of adjustment disorder. Patient will be prescribed with individualized homoeopathic medicine based on totality of symptoms and dose will be assessed based upon the Individuality, repetition of medicine based on their improvement of symptoms. Pre and Post assessment will be done by using Adjustment disorder new module 20 scale |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with adjustment disorder according to ICD-10 criteria.
Age 19 to 64 years
Both genders |
|
| 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 |
| Effectiveness of homoeopathic medicine in managing of Adjustment disorder will be assessed by the changes in the scores on the ADNM-20 from the baseline to the end of the study |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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/ Phase 4 |
|
Date of First Enrollment (India)
|
10/07/2024 |
| 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="2"
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
|
Adjustment disorder Defines it is a maladaptive reaction to an identifiable psychosocial Stressor or multiple stressors (e.g., divorce, illness or disability, socio-economic Problems, conflicts at home or work) that usually emerges within a month of the Stressor. The disorder is characterized by preoccupation with the stressor or its consequences, including excessive worry, recurrent and distressing thoughts about the stressor, or constant rumination about its implications, as well as by failure to Adapt to the stressor that causes significant impairment in personal, family, social, Educational, occupational or other important areas of functioning. Homeopathy’s emphasis on treating the whole person, including their mental and emotional state, makes it a promising option for managing adjustment disorder. Since this condition is often intertwined with psychological factors, a treatment approach that addresses the mind could be particularly beneficial. Homeopathy’s individualized approach may help identify and target the specific mental and emotional imbalances contributing to adjustment disorder, potentially leading to improved outcomes and a better quality of life for those affected. There is currently insufficient research to conclusively prove that homeopathic medicine can effectively manage adjustment disorder. Existing studies indicate that psychotherapy is the primary treatment for adjustment disorder. Therefore, this research aims to provide evidence supporting the efficacy of homeopathic medicine in the management of adjustment disorder.
Patients presenting with symptoms suggestive of adjustment disorder will be screened and diagnosed according to ICD-10.Patients will receive homoeopathic treatment tailored to their symptoms and constitution. Repertorization and medicine will be based on totality of symptoms and will be correlated with Homoeopathic Materia medica. Patients will be followed up at regular intervals (bi-weekly) for a specified duration to monitor treatment progress and assess outcome measures. Data regarding the outcome measures will be assessed by subsequent follow up and recorded, Pre and post assessment will be done using ADNM 20.
|