| CTRI Number |
CTRI/2024/09/073574 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
06/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Usefulness of Homoeopathic medicines in Adjustment Disorder |
|
Scientific Title of Study
|
The effectiveness of Individualised Homoeopathic Medicines in Adjustment Disorder with supportive couselling-A single blind randomised placebo controlled trial |
| 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 Anupriya T |
| Designation |
Post Graduate Scholar,Department of psychiatry |
| Affiliation |
National Homoeopathy Research Institute in Mental Health,Kottayam |
| Address |
National Homoeopathy Research Institute in Mental Health,Sachivothamapuram (P O),Kurichy,Kottayam
Kottayam
KERALA
686532
India |
| Phone |
8113819585 |
| Fax |
|
| Email |
anupriyat28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Bhuvaneswari |
| Designation |
Professor,Head of the department,Research officer,Scientist III,Department of psychiatry |
| Affiliation |
National Homoeopathy Research Institute in Mental Health,Kottayam |
| Address |
National Homoeopathy Research Institute in Mental Health,Sachivothamapuram (P O),Kurichy
Kottayam
KERALA
686532
India |
| Phone |
8281475541 |
| Fax |
|
| Email |
dr.r.bhuvaneswari2021@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R BHUVANESWARI |
| Designation |
Professor,Head of the department,Research officer,Scientist III,Department of psychiatry |
| Affiliation |
National Homoeopathy Research Institute in Mental Health,Kottayam |
| Address |
National Homoeopathy Research Institute in Mental Health,Kottayam
Kottayam
KERALA
686532
India |
| Phone |
8281475541 |
| Fax |
|
| Email |
dr.r.bhuvaneswari2021@gmail.com |
|
|
Source of Monetary or Material Support
|
| NATIONAL HOMOEOPATHY RESEARCH INSTITUTE IN MENTAL HEALTH ,KOTTAYAM |
|
|
Primary Sponsor
|
| Name |
DR ANUPRIYA T |
| Address |
NATIONAL HOMOEOPATHY RESEARCH INSTITUTE IN MENTAL HEALTH ,SACHIVOTHAMAPURAM(P O),KOTTAYAM,KERALA,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 Anupriya T |
National Homoeopathy Research Institute in Mental Health |
OPD-Room number 48 ,IPD,Peripheral camps,Department of psychiatry
Kottayam
KERALA |
8113819585
anupriyat28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,National Homoeopathy Research Institute in Mental Health |
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 |
Individualised Homoeopathic medicine with supportive counselling |
Individualised Homoeopathic medicines will be selected in minimum dose and
potency which gradually increases as per the need of the case with supportive counselling.The potency, dose, and frequency of repetition will be determined according to the homoeopathic principles.The above homoeopathic intervention will be given for a period of 6 months |
| Comparator Agent |
Placebo with supportive couselling |
Placebo 4-6 globules of number 30 in size will be administered with supportive counselling given for a period of 6 months. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Participants who are diagnosed with adjustment disorder as per DSM 5 criteria
Patients with Adjustment disorder new module 20(ADNM 20) score ≥ 47.5
Those who score 10 &above in the depression subscale,8 &above in the anxiety subscale
, and 15&above in the stress subscale of DASS 21
Presence of a psychological stressor(score ≥ 1 ), at least one preoccupation and failure to
adapt symptom, positive response of item 16, evidence of functional impairment(score ≥2)
in International Adjustment Disorder Questionnaire(IADQ). |
|
| ExclusionCriteria |
| Details |
Patients with prolonged grief disorder
Patients with acute stress reaction
Patients with recurrent depressive disorder
Patients with suicidal and homicidal tendencies.
Patients with postpartum depression
Pregnant and lactating mother
Patients with serious systemic illness
Separation anxiety disorders of childhood |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cases will be assessed by using Depression Anxiety Stress Scale (DASS) to determine the severity of
symptoms. |
Every 3rd month from baseline till the conclusion of study(6 month) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The severity of depression, anxiety, and stress will be compared |
At baseline and
end of treatment |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
17/09/2024 |
| 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="1"
Months="6"
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
|
This study is a randomized, single-blind placebo-controlled trial comparing individualized homoeopathic medicine and placebo with supportive counselling for 18 months(12 months enrollment and 6 months follow-up), and will be conducted in OPD,IPD and peripheral units of Department of Psychiatry at National Homoeopathy Research Institute in Mental Health, Kottayam. Patients shall be screened for adjustment disorder with a verbal screening questionnaire prepared using DSM 5 Diagnostic Criteria. The detailed screening was done by the principal investigator by using Adjustment Disorder New Module 20(ADNM 20). After the screening, probable diagnosis is done by using IADQ(International Adjustment Disorder Questionnaire) and DASS 21(Depression Anxiety Stress) scale. The consultant Psychiatrist will confirm the diagnosis. After enrollment, each patient will be assigned to either group A (homeopathic medicine with supportive counseling) or group B (placebo with supportive counseling) as intervention through random numbers. Following inclusions, patients will receive a prescription of the individualized homoeopathic medicine and placebo according to a randomized assignment sequence to either homeopathy or placebo group generated by using online randomization tools. The patients were randomly assigned in a 1:1 ratio to receive either individualized homoeopathic medicine or placebo using a Simple randomization procedure. Framing up the symptom totality,repertorisation will be done by using the appropriate repertory as per the requirement of the
case. The final selection of the medicine will be done after comparing it with homeopathic materia
medica.The potency, dose, and frequency of repetition will be determined according to the
homoeopathic principles.Cases will be assessed at baseline Depression Anxiety Stress Scale (DASS) to determine the severity of the condition. The outcome of treatment will be assessed according to Depression Anxiety Stress Scale( DASS)-21 items, at the 3rd,6th, 9th, and 12th months. The severity of depression, anxiety, and stress will be compared at baseline and end of treatment.
|