| CTRI Number |
CTRI/2024/04/066428 [Registered on: 29/04/2024] Trial Registered Prospectively |
| Last Modified On: |
26/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic treatment of depression in elderly people. |
|
Scientific Title of Study
|
A Clinical Study on the utility of individualized homoeopathic medicine in the treatment of Geriatric Depression using Complete repertory- A Prospective, Interventional Study. |
| 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 Akansha Singh |
| Designation |
Postgraduate trainee |
| Affiliation |
State National Homoeopathic Medical College and Hospital, 1-Viraj Khand, Gomti Nagar, Lucknow |
| Address |
Department of Case Taking and Repertory, State National Homoeopathic Medical College and Hospital, 1-Viraj Khand,
Gomti Nagar, Lucknow, Uttar Pradesh- 226010
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8957738732 |
| Fax |
|
| Email |
akansha505singh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Farheen |
| Designation |
Lecturer |
| Affiliation |
State National Homoeopathic Medical College and Hospital, 1-Viraj Khand, Gomti Nagar, Lucknow |
| Address |
Department of Case Taking and Repertory, State National Homoeopathic Medical College and Hospital, 1-Viraj Khand,
Gomti Nagar, Lucknow, Uttar Pradesh- 226010
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
7007582785 |
| Fax |
|
| Email |
farheen.fb2017@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akansha Singh |
| Designation |
Postgraduate trainee |
| Affiliation |
State National Homoeopathic Medical College and Hospital |
| Address |
Department of Case taking and Repertory,State National Homoeopathic Medical College and Hospital, 1-Viraj Khand,Gomti Nagar, Lucknow, Uttar Pradesh- 226010
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8957738732 |
| Fax |
|
| Email |
akansha505singh@gmail.com |
|
|
Source of Monetary or Material Support
|
| State National Homoeopathic Medical College and Hospital, 1-Viraj Khand,
Gomti Nagar, Lucknow |
|
|
Primary Sponsor
|
| Name |
Dr Akansha Singh |
| Address |
Department of Case Taking and Repertory, State National Homoeopathic Medical College and Hospital, 1-Viraj Khand,
Gomti Nagar, Lucknow, Uttar Pradesh- 226010 |
| 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 Akansha Singh |
State National Homoeopathic Medical College and Hospital |
OPD Number 10, State National Homoeopathic Medical College and Hospital, 1-Viraj Khand,
Gomti Nagar, Lucknow, Uttar Pradesh- 226010
Lucknow
UTTAR PRADESH |
8957738732
akansha505singh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethical Committee of State National Homoeopathic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F320||Major depressive disorder, singleepisode, mild, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic medicine |
Intervention is planned as administering via oral route indicated homoeopathic medicine in patients suffering from geriatric depression after detailed case taking and repertorization. Individualized homoeopathic medicine will be given in varying potencies of centesimal scale depending upon the susceptibility of the patient. Each dose shall consist of 4-5 globules of cane sugar medicated with single medicine(preserved in 90%v/v ethanol) to be taken orally on an empty stomach. Dosage and repetition will depend upon the individual requirement of the cases. The patient will be called for follow up after every 15 days and the final assessment will be done after 6 months.At every follow up after reexamining the case it will be decided whether the patient will receive a dose of individualized homoeopathic medicine or placebo. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient between the age group of 60-80 years and of both sexes.
2.Patient who are willing to participate in the study and provide written consent.
3.Patients who are not suffering from any other complicated systemic disease. |
|
| ExclusionCriteria |
| Details |
1.Patient of age below 60 years and above 80 years.
2.Patient who do not give their consent and are not willing to come for follow up.
3.Patients suffering from Major Depressive Disorder with psychotic symptoms and unstable psychiatric illness.
4.Geriatric patients with Dementia or other neurocognitive disorders.
5.Patient suffering from uncontrolled Hypertension, Diabetes Mellitus or any metabolic disorders.
6.Patient currently receiving standard psychiatric therapy (conventional medication).
7.Patients who have a habit of alcohol or substance abuse.
8.Any medical condition requiring emergency or surgical intervention. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the Geriatric Depression Scale-15 Score at baseline and after 6 months of treatment to know the utility of individualized homoeopathic medicine. |
12 weeks, 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare Geriatric Depression Scale-15 Score at baseline and after 3 months to assess the utility of Complete Repertory in selection of individualized homoeopathic medicine. |
4 weeks, 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
07/05/2024 |
| 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 is an open label ,single arm, prospective, interventional study which aims to assess the utility of individualized homoeopathic medicine in the treatment of geriatric depression.Individualized homoeopathic medicine will be prescribed in centesimal scale after detailed case taking and repertorization with the help of Complete repertory. Geriatric Depression Scale-15 Score will be calculated every month upto 6 months. The difference between the GDS-15 score before and after the treatment will be compared and analyzed. Depression in the geriatric population is quite prevalent but it is often undiagnosed or untreated. Recent data derived from the first wave of Longitudinal Aging Study in India showed 8.3% prevalence of depression in those above 60 years of age.This is nearly ten times more than self-reported depressive complaints. A more holistic approach is required for the treatment of geriatric cases by considering their mental, physical, spiritual and economical aspects. This approach is not new for Homoeopathic mode of treatment because in Homoeopathy we always treat the patient with a holistic approach by considering the individuality of the patient.
Therefore, the present study is undertaken to explore how individualized homoeopathic medicine selected on the basis of Complete Repertory can prove to be useful in the treatment of Geriatric Depression. |