FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
Close