| CTRI Number |
CTRI/2024/03/063625 [Registered on: 05/03/2024] Trial Registered Prospectively |
| Last Modified On: |
03/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Homoeopathic Medicines in the management of emotional or behavioral reaction to a stressful event or change in a persons life |
|
Scientific Title of Study
|
A clinical study to assess the efficacy of homoeopathic
Constitutional medicine in the treatment of adjustment disorder
Using ADNM 20 questionnaire
|
| 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 Rehna Rahim |
| Designation |
PG Scholar |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Department of Psychiatry OPD Room No 5C Vinayaka Missions
Homoeopathic Medical College and Hospital NH 47 Sankari Main
Road Seeragapadi
Department of Psychiatry OPD Room No 5C Vinayaka Missions
Homoeopathic Medical College and Hospital NH 47 Sankari Main
Road Seeragapadi
Salem
TAMIL NADU
636308
India |
| Phone |
09207937797 |
| Fax |
|
| Email |
rehnagruz@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Freeda M Joseph |
| Designation |
Assistant Professor |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Department of Psychiatry OPD Room No 5C Vinayaka Missions
Homoeopathic Medical College and Hospital NH 47 Sankari Main
Road Seeragapadi
Salem
TAMIL NADU
636308
India |
| Phone |
8943929920 |
| Fax |
|
| Email |
freedajose92@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Freeda M Joseph |
| Designation |
Assistant Professor |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Department of Psychiatry OPD Room No 5C Vinayaka Missions
Homoeopathic Medical College and Hospital NH 47 Sankari Main
Road Seeragapadi
Department of Psychiatry OPD Room No 5C Vinayaka Missions
Homoeopathic Medical College and Hospital NH 47 Sankari Main
Road Seeragapadi
TAMIL NADU
636308
India |
| Phone |
8943929920 |
| Fax |
|
| Email |
freedajose92@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institutional Vinayaka Missions Homoeopathic Medical College And Hospital NH 47 Sankari Main
Road Seeragapadi Salem 636308 Tamilnadu |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Homoeopathic Medical College And Hospital |
| Address |
NH 47 Sankari Main
Road Seeragapadi Salem 636308 Tamilnadu |
| 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 Rehna Rahim |
Vinayaka Missions Homoeopathic Medical College and Hospital |
Department of
Psychiatry OPD Room
No 5C Vinayaka
Missions Homoeopathic
Medical College and
Hospital NH 47 Sankari
Main Road
Seeragapadi Salem
Salem
TAMIL NADU |
9207937797
rehnagruz@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Vinayaka Missions Kirupananda Variyar Medical College And Hospital Salem |
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 Medicine |
Homoeopathic medicines are selected based on individualization of the patient. Based on the susceptibility of the patient, the dose is selected. Medicine is administered via oral route. One dose of Medicine is administered orally at the start of treatment, and the follow-up is taken once a month. The medicine will be repeated if the symptoms are not relieved, and follow-up will be followed for a period of six months to evaluate the result of treatment. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Both sexes are selected.
Patients with the age groups from 18 to 55 years are selected. |
|
| ExclusionCriteria |
| Details |
Patient who is diagnosed with major depressive disorder will be excluded.
Patients with chronic neurological conditions like epilepsy, stroke and degenerative
disorders like dementia and Alzheimer’s disease will be excluded.
Patients with psychotic disorder will be excluded.
Patients with substance use disorders will be excluded.
Patients with mental retardation will be excluded.
Patients having a score more or equal to 7 in Suicidal Behaviors Questionnaire Revised will be
excluded. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Diagnosis based on Diagnostic and Statistical Manual of Mental Disorders, Fifth edition
(DSM-5) |
AT baseline and at the end of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
It is expected that the proposed study will be
useful in reducing the symptoms of adjustment disorder using ADNM 20 Questionnaire |
At baseline and at the end of the study |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/04/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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 is among the most often used mental disorder diagnosis in healthcare. It is
a condition strongly tied to acute and chronic stress. AD is one of the few diagnostic entities in
which an external stressful event is linked to the development of symptoms. These events may
even lead to psychopathological alterations. It generally carries an excellent prognosis but in
some individuals it is associated with self harm and suicide. AD is a common diagnosis in
psychiatric settings and carries a significant rate of morbidity. An average of 12% of the total
population suffers from adjustment disorder. It has a high prevalence in clinical and consultant
liaison psychiatry populations. Despite AD is a very common disorder in the present time, the
clinical suggestion of a large prevalence in the general population and the high frequency of its
diagnosis in the clinical settings, there has been relatively little research reported and,
consequently, very few hints about its treatments. Evaluation is problematic since it may be
mistaken for major depression, generalised anxiety or non-pathological reactions to stress. It has
been included in psychiatric classifications for over 40 years but has received little attention from
the research community. Its measurement by structured interview is difficult since it is not
included in many instruments. AD is commonly diagnosed by specialists, but it has found little
place in the scientific literature. The research has traditionally been hindered by its lack of clear
diagnostic criteria. However, more extensive research is needed in this topic to prove the
effectiveness of individualised homoeopathic medicine. It is essential to study AD in terms of
aetiology, diagnosis, and treatment by homoeopathic constituitional approach. |