CTRI Number |
CTRI/2017/03/008078 [Registered on: 14/03/2017] Trial Registered Prospectively |
Last Modified On: |
29/11/2018 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Homeopathy |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
|
Homeopathic treatment of geriatric depression |
Scientific Title of Study
|
A double-blind, randomized, placebo-controlled efficacy trial of individualized homeopathic treatment of geriatric depression |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
U1111-1193-8257 |
UTN |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Subhranil Saha |
Designation |
Postgraduate Trainee |
Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
Address |
OPD No. 11, Dept. of Case Taking and Repertory, National Institute of Homoeopathy, Block GE, Sector III, Salt Lake
Kolkata WEST BENGAL 700106 India |
Phone |
9836187425 |
Fax |
|
Email |
drsubhranilsaha@hotmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Subhranil Saha |
Designation |
Postgraduate Trainee |
Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
Address |
OPD No. 11, Dept. of Case Taking and Repertory, National Institute of Homoeopathy, Block GE, Sector III, Salt Lake
Kolkata WEST BENGAL 700106 India |
Phone |
9836187425 |
Fax |
|
Email |
drsubhranilsaha@hotmail.com |
|
Details of Contact Person Public Query
|
Name |
Subhranil Saha |
Designation |
Postgraduate Trainee |
Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
Address |
OPD No. 11, Dept. of Case Taking and Repertory, National Institute of Homoeopathy, Block GE, Sector III, Salt Lake
Kolkata WEST BENGAL 700106 India |
Phone |
9836187425 |
Fax |
|
Email |
drsubhranilsaha@hotmail.com |
|
Source of Monetary or Material Support
|
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Govt. of west Bengal, Drainage Canal Road, Doomurjala, Howrah 711104, West Bengal, India |
Midnapore Homoeopathic Medical College and Hospital, Govt. of West Bengal, PO Midnapore,
Paschim Medinipur 721101, Medinipur, West Bengal |
The Calcutta Homoeopathic Medical College and Hospital, Govt. of West Bengal, 265-266, A.
P. C. Road, Kolkata 700009, West Bengal |
|
Primary Sponsor
|
Name |
MBHM College Hospital MHM College Hospital The CHM College Hospital |
Address |
(1) Drainage Canal Road, Doomurjala, Howrah 711104, West Bengal, India (2) PO Midnapore, Paschim Medinipur 721101, West Bengal, India (3) 265-266, APC Road, Kolkata 700009, West Bengal,
India |
Type of Sponsor |
Government medical college |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 3 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Shubhamoy Ghosh |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
OPD 3, every Monday, Drainage Canal Road, Doomurjala Haora WEST BENGAL |
9831034229
shubhamoy67@gmail.com |
Kaushik Deb Das |
Midnapore Homeopathic Medical College and Hospital |
OPD 5, every Tuesday, PO Midnapore, Paschim Medinipur Medinipur WEST BENGAL |
9932298682
drkaushikddas75@gmail.com |
Himangsu Hait |
The Calcutta Homoeopathic Medical College & Hospital |
OPD 12, every Tuesday, 265-266, A.P.C. Road, Kolkata
700009 Kolkata WEST BENGAL |
9433565680
haitdrhimangsu@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 3 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
Approved |
Institutional Ethics Committee |
Approved |
Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
Health Type |
Condition |
Patients |
Depression, (1) ICD-10 Condition: F339||Major depressive disorder, recurrent, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Individualized homeopathic
medicine in centesimal
potencies |
In centesimal potencies, each dose shall consist of 4 cane sugar globules medicated with a single drop of the indicated medicine, preserved in 88% v/v
ethanol. Repetition 24, 12 or 8 hourly or even oftener,
depending upon the individual requirement of the case. Each dose to be taken orally on clean
tongue in empty stomach. Duration of therapy: 3 months |
Comparator Agent |
Placebo |
Placebo each dose consists of 4 cane sugar globules no. 30 moistened with a single drop of rectified spirit; indistinguishable from verum. To be taken thrice
a day orally on clean tongue in empty stomach for 3 months |
|
Inclusion Criteria
|
Age From |
60.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Both |
Details |
Aged 60-80 years, both sexes, and suffering from depression [Geriatric Depression Score: ≥ 5] |
|
ExclusionCriteria |
Details |
Patients who are too sick for consultation, unwilling to take part, unable to read, and not giving consent to join the study, diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting QoL, currently receiving standard psychiatric therapy (conventional medication), chronic alcoholism, drug abuse and/or dependence, self-reported immune-compromised state, and undergoing homeopathic treatment for any chronic disease within last 6 months. |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Pharmacy-controlled Randomization |
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
15-items short-form Geriatric Depression Score (translated Bengali version) |
At baseline and after 3 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
16-items Quality of Life Scale score (translated Bengali version) |
At baseline and after 3 months |
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
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)
|
03/04/2017 |
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)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
None yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Depression
is the most common mental disorder in community settings, and is a major cause
of disability across the world. In 1990, it was the fourth commonest cause of
loss of disability adjusted life years in the world, and by 2020, it is
projected to become the second commonest cause. A range of therapeutic approaches
are available, the most widely used, in developed countries, is antidepressant drugs.
Still, there still remain flaws in the treatment of depression with
antidepressants, in terms of efficacy, adverse effects, toxicity overdose, non-compliance
to treatment and delayed onset of their therapeutic response. Use of homeopathy
to treat psychiatric problems is widespread, and the need for more high quality
controlled trials has been identified. Meta-analyses and systematic reviews
have drawn mixed conclusions as to whether homeopathy is more effective than
placebo in general medicine. The
authors undertook a cross-sectional validation survey, followed by open,
observational trial involving 60 patients suffering from geriatric depression in
the geriatric outpatient of Midnapore Homeopathic Medical College &
Hospital (MHMC&H), Govt. of West Bengal, India from May 2015 to April 2016
using Geriatric Depression Scale (GDS). After
3 months of treatment, moderate to large effect size was observed and the questionnaire psychometrics appeared
satisfactory. The
authors intend to undertake a multicenter placebo-controlled double-blind
randomized efficacy trial of individualized homeopathic treatment on minimum
150 patients suffering from geriatric depression at Midnapore Homoeopathic
Medical College and Hospital (MHMC&H), Mahesh Bhattacharyya Homoeopathic
Medical College and Hospital (MBHMC&H); and The Calcutta Homoeopathic
Medical College and Hospital (CHMC&H). We hypothesize that individualized
homeopathic treatment may produce effect significantly different from placebo
in treatment of geriatric depression. The outcome measures are Geriatric
depression score questionnaire and Quality of Life Scale score questionnaire,
to be measured at baseline and after 3 months. Intervention is planned as
administering indicated homeopathic remedies in centesimal potencies or
placebo, indistinguishable from verum. The generated results will be analyzed
in the end using appropriate statistical tests and the results will be
published in scientific research journals. |