| CTRI Number |
CTRI/2024/03/064364 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
16/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homeopathic treatment of depression in aged people |
|
Scientific Title of Study
|
Efficacy of individualized homoeopathic medicines in reducing geriatric depression: A double blind, randomized, placebo-controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1304-1389 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anandita Ray |
| Designation |
Postgraduate Trainee |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Dept. of Repertory, OPD room no. PG3 and Psychiatry, 12, Gobinda Khatick Road, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
7003495404 |
| Fax |
|
| Email |
ananditaray.1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Rajat Kumar Pal |
| Designation |
Head |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Dept. of Repertory, OPD room nio. PG3, 12, Gobinda Khatick Road, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
9433130996 |
| Fax |
|
| Email |
drrajatkumarpal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Rajat Kumar Pal |
| Designation |
Head |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Department of Repertory, OPD room no. PG3, 12, Gobinda Khatick Road, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
9433130996 |
| Fax |
|
| Email |
drrajatkumarpal@gmail.com |
|
|
Source of Monetary or Material Support
|
| D. N. De Homoeopathic Medical College and Hospital, 12, Gobinda Khatick Road, Kolkata 700046 |
|
|
Primary Sponsor
|
| Name |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick Road, Kolkata 700046 |
| Type of Sponsor |
Government 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 Anandita Ray |
Psychiatry & PG-3 OPD |
D. N. De Homoeopathic Medical College and Hospital, 12, Gobinda Khatick Road, Kolkata 700046
Kolkata
WEST BENGAL |
7003495404
ananditaray.1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of D. N. De Homoeopathic Medical College & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F330||Major depressive disorder, recurrent, mild, (2) ICD-10 Condition: F331||Major depressive disorder, recurrent, moderate, (3) ICD-10 Condition: F320||Major depressive disorder, singleepisode, mild, (4) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Identical-looking placebos plus concomitant care |
This group will receive placebos, identical in appearance to the
verum. Each dose will consist of 4 cane sugar globules no.40, moistened with 90% v/v ethanol, to
be taken orally on a clean tongue on empty stomach; dosage and repetition will be maintained
depending upon the individual requirement of the cases. All sundry items will be procured from
a Good Manufacturing Practice (GMP) certified firm. All the enrolled patients of both groups will receive concomitant care in the form of cognitive behavioural therapy (CBT). CBT will be administered according to the case by a conventionally trained psychologist. Duration of therapy is 3 months. |
| Intervention |
Individualized homoeopathic medicines in centesimal potencies plus concomitant care |
Intervention is planned as administering indicated homoeopathic medicines
in centesimal potencies (CH). Each dose will consist of 4 cane sugar globules no. 40 moistened
with the indicated medicine (preserved in 90% v/v ethanol), to be taken orally on clean tongue in
empty stomach; dosage and repetition depending upon the individual requirement of the cases.
Patients will be advised to refrain from handling the globules or from eating, drinking, smoking
or brushing teeth within 30 minutes of taking the globules and will be asked to suck the globules
rather than simply swallowing those. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP)
certified firm. All the enrolled patients of both groups will receive concomitant care in the form of cognitive behavioural therapy. CBT will be administered according to the case by a conventionally trained psychologist. Duration of therapy is 3 months. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
A. Elderly people with depression of not less than two weeks duration, with a minimum of two
typical and two common symptoms will be included in the study.
• Typical symptoms:
o Depressed mood
o Loss of interest and enjoyment.
o Increased fatigability and diminished activity
• Common symptoms:
o Reduced concentration and attention.
o Reduced self-esteem and self-confidence.
o Guilt feeling and unworthiness (mild type of episode)
o Bleak and pessimistic view of the future.
o Disturbed Sleep
o Diminished appetite
B. Age above 60 years
C. Mild and moderate depression [HDRS score - 8-13 mild, 14-18 moderate]
D. GDS-15 score more than 5
E. Participants having prior experience or knowledge of the treatment; e.g., primed to expect
‘homoeopathic aggravation’ and available treatment options for the disease conditions, intimated
through Patient Information Sheet. |
|
| ExclusionCriteria |
| Details |
A. Mood disturbance when associated with bipolar affective disorder, schizophrenia,
schizophreniform disorder, schizoaffective disorder, or psychotic disorder.
B. Severe dementia (MoCA score less than 10)
C. Currently receiving any effective anti-depressant.
D. Active suicidal
E. Uncontrolled systemic disorders.
F. Undergoing homoeopathic treatment for any chronic disease within the last six months.
G. Vulnerable population- Unconscious, non-ambulatory, too sick for consultation, differently abled, terminally ill or critically ill patients, mentally incompetent people.
H. Self-reported immune-compromised state.
I. Patients with the habit of tobacco chewing and/or smoking, alcoholism, and/or
any other form(s) of substance abuse and/or dependence.
J. Simultaneous participation in any other clinical trials
K. Not Providing with written informed consent to participate voluntarily |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hamilton Depression Rating Scale (HDRS 17) |
Baseline, every month, up to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Geriatric Depression Scale 15 (GDS-15) |
Baseline, every month, up to 3 months |
| Measure Yourself Medical Outcome Profile-2 (MYMOP-2) |
Baseline, every month, up to 3 months |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ananditaray.1996@gmail.com].
- For how long will this data be available start date provided 01-04-2026 and end date provided 31-12-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NA
|
|
Brief Summary
|
Geriatric depression is a term used to describe a depressive episode that affects people beyond the age of sixty. A prevalence rate of 17.1% for clinically severe depression symptoms was found in this age group by meta-analyses. One of the most prevalent ailments for which people seek homoeopathic treatment is depression. An extensive search for both published and unpublished research has shown that the dearth of high-quality clinical trials has restricted the data supporting homeopathy’s efficacy in treating depression. It is necessary to do additional research, which should involve carefully planned controlled trials with an adequate number of people. This double-blind, randomized, placebo-controlled trial on 54 patients suffering from geriatric depression intends to ascertain the probable efficacy of individualized homoeopathic treatment versus placebo. Assessment will be done by Hamilton Depression Rating Scale (HDRS) [Primary outcome], Geriatric Depression Scale 15(GDS-15) [Secondary outcome], Measure Yourself Medical Outcome Profile version2.0 (MYMOP-2) [Secondary outcome] to be measured at baseline and every month, up to 3 months. Comparative analysis will be carried out to detect group differences, if any. Results will be published in scientific journals. |