| CTRI Number |
CTRI/2015/06/005927 [Registered on: 17/06/2015] Trial Registered Retrospectively |
| Last Modified On: |
04/06/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homeopathy in geriatric psychological disorders |
|
Scientific Title of Study
|
Psychometric evaluation of different mindfulness and emotional wellbeing outcome scales in Bengali language: a preliminary study among geriatric population visiting a homeopathic hospital |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHMCH/18/2015-16 |
Protocol Number |
| U1111-1169-7929 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subhranil Saha |
| Designation |
Senior Research Fellow |
| Affiliation |
Dr. Anjali Chatterjee Regional Research Institute, under Central Council for Research in Homeopathy |
| Address |
50, Rajendra Chatterjee Road, Kolkata
Kolkata
WEST BENGAL
700035
India |
| Phone |
|
| Fax |
|
| Email |
drsubhranilsaha@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Subhranil Saha |
| Designation |
Senior Research Fellow |
| Affiliation |
Dr. Anjali Chatterjee Regional Research Institute, under Central Council for Research in Homeopathy |
| Address |
50, Rajendra Chatterjee Road, Kolkata
Kolkata
WEST BENGAL
700035
India |
| Phone |
|
| Fax |
|
| Email |
drsubhranilsaha@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Subhranil Saha |
| Designation |
Senior Research Fellow |
| Affiliation |
Dr. Anjali Chatterjee Regional Research Institute, under Central Council for Research in Homeopathy |
| Address |
50, Rajendra Chatterjee Road, Kolkata
WEST BENGAL
700035
India |
| Phone |
|
| Fax |
|
| Email |
drsubhranilsaha@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Midnapore Homeopathic Medical College and Hospital, PO and PS Medinipur, Dist Paschim Medinipur 721101, West Bengal |
|
|
Primary Sponsor
|
| Name |
Midnapore Homeopathic Medical College and Hospital |
| Address |
PO Midnapore, Paschim Medinipur 721101, West Bengal |
| 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 Kaushik D Das |
OPD 3, every Tuesday, Midnapore Homeopathic Medical College and Hospital |
PO Midnapore, Paschim Medinipur 721101
Medinipur
WEST BENGAL |
03222275311
mhmch1945@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Midnapore Homeopathic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Geriatric depression, stress, and anxiety, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homeopathic medicines in centesimal or 50 millesimal scale |
In centesimal scale, each dose shall consist of 4 cane sugar globules medicated with a single drop of the indicated medicine, preserved in 83.1% v/v ethanol. In 50 millesimal scale, a single medicated cane sugar globules of poppy seed size (no.10) dissolved in 50 ml distilled water with addition of 2 drops of 83.1% v/v ethanol, 10 doses marked on the vial, each dose of 5 ml to be taken after 10 uniformly forceful downward strokes to the vial in 45 ml normal water in a clean cup, to stir well, to take 5 ml of this liquid orally, and to discard rest of the liquid in the cup. Repetition 24, 12 or 8 hourly or even oftener, depending upon the individual requirement of the case. |
| Comparator Agent |
None |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patients of 60-85 years and both sexes, suffering from geriatric depression, stress, or anxiety |
|
| ExclusionCriteria |
| Details |
Patients who are too sick for consultation, unwilling to stay after the doctor’s visit, unable to read patient information sheets, and not giving consent to join the study, diagnosed cases of unstable mental or psychiatric illness or other systemic disease affecting QoL, currently receiving standard psychiatric therapy (conventional medication), self-reported immune-compromised state, substance abuse |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Geriatric Depression Scale, Perceived Stress Scale, and Hamilton’s Anxiety Scale |
At baseline and after 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mindfulness Attention Awareness Scale, Quality of Life Scale, and Numeric Rating Scale |
At baseline and after 3 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 |
|
Date of First Enrollment (India)
|
01/01/2015 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
To be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Although a number of studies have suggested positive effects of mindfulness-based training on psychological wellbeing, no studies have evaluated the role of homeopathy in mindfulness, and emotional well-being in the geriatric population. In this project, we intend to develop translated Bengali versions of these four available outcome measures through standardized forward-backward translation method and to validate it in a homeopathic hospital setting. This project is the initial work before conducting a prospective, double-blind, randomized, placebo-controlled study evaluating the efficacy of individualized homeopathic treatment in reducing depression, stress, and anxiety; and improving mindfulness and quality of life among the geriatric population seeking homeopathic care. Six outcome parameters are being assessed: Geriatric Depression Scale, Perceived Stress Scale, Hamilton’s Anxiety Scale, Mindfulness Attention Awareness Scale, Quality of Life Scale, 0-10 point Numeric Rating Scale assessing patients’ self-reported intensity of complaints at baseline and after 3 months. Target sample size is about 120. Since January 1, 2015 till date, 80 patients have been enrolled from the out-patient of Midnapore Homeopathic Medical College and Hospital. Consistent improvement is being observed in the condition of the patients. Intention to treat population shall be analyzed in the end. Descriptive statistics shall be presented as absolute values, percentages, means and standard deviations. P<0.05 two-tailed will be considered as statistically significant. Sensitivity, specificity, reproducibility, and sensitivity to change of the used questionnaire shall be evaluated. Concurrent validity shall be tested by comparing with changes assessed with 10-point numeric rating scales. Parametric or non-parametric tests will be used to compare longitudinally obtained data measured repeatedly in same patients at different points of time. Aurum metallicum, Opium, Phosphoric acid etc. are being used successfully to treat different cases. |