| CTRI Number |
CTRI/2022/07/044290 [Registered on: 25/07/2022] Trial Registered Prospectively |
| Last Modified On: |
19/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
"Depression in older age and its Homoeopathic Management" |
|
Scientific Title of Study
|
A clinical study on Geriatric Depression And its Homoeopathic Management |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
V Vishnupriya |
| Designation |
PG SCHOLAR |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Department of Psychiatry OPD Room No 5C Vinayaka Mission Homoeopathic Medical college And Hospital NH 47 Sankari Main Road Seeragapadi Salem Tamilnadu
Department of Psychiatry OPD Room No 5C Vinayaka Mission Homoeopathic Medical college And Hospital NH 47 Sankari Main Road Seeragapadi Salem Tamilnadu
Salem
TAMIL NADU
636308
India |
| Phone |
9786684901 |
| Fax |
|
| Email |
vvishnu0406@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr k S Lalithaa |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College And Hospital |
| Address |
Department of Psychiatry OPD Room No 5C Vinayaka Missions Homoeopathic Medical college And Hospitals NH 47 Sankari Main Road Seeragapadi Salem
Department of Psychiatry OPD Room No 5C Vinayaka Missions Homoeopathic Medical college And Hospitals NH 47 Sankari Main Road Seeragapadi Salem Seeragapadi Salem Tamilnadu
Salem
TAMIL NADU
636308
India |
| Phone |
9940245577 |
| Fax |
|
| Email |
drlalithaagogul@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr k S Lalithaa |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College And Hospital |
| Address |
Department of Psychiatry OPD Room No 5C Vinayaka Missions Homoeopathic Medical college And Hospital NH 47 Sankari Main Road Seeragapadi Salem
Department of Psychiatry OPD Room No 5C Vinayaka Missions Homoeopathic Medical college And Hospital NH 47 Sankari Main Road Seeragapadi Salem
Salem
TAMIL NADU
636308
India |
| Phone |
9940245577 |
| Fax |
|
| Email |
drlalithaagogul@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Homoeopathic Medical College and Hospital NH 47 Sankari main road Seeragapadi Salem Tamilnadu 63608 |
|
|
Primary Sponsor
|
| Name |
V Vishnu priya |
| Address |
Department of Psychiatry OPD Room no 5C Vinayaka Missions Homoeopathic Medical College and Hospital NH 47 Sankari main road Seeragapadi Salem Tamilnadu 636308 |
| 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 |
| V Vishnu priya |
Vinayaka Missions Homoeopathic Medical College and Hospital |
Department of psychiatry OPD Room no 5C Vinayaka Missions Homoeopathic Medical College and Hospital NH 47 Sankari main road Seeragapadi Salem Tamilnadu 636308
Salem
TAMIL NADU |
9786684901
vvishnu0406@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee vinayaka missions kirupananda variyar medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F333||Major depressive disorder, recurrent, severe with psychotic symptoms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
homoeopathic medicine |
homoeopathic medicine are selected based on indivualization and the range of potency 30C 200C 1M 10M will be used single dose of indicated remedy will be administered orally every month for a duration of 6 months considering disease state and vitality of patients |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
60 to 75 year of age elderly persons who have the depressive episodes |
|
| ExclusionCriteria |
| Details |
patients with active treatment for any other chronic disease
patients with organic mental disorder |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| diagnosis based on clinical presentation such as psychomotor retardation agitation cognitive imparment |
at baseline and after 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| it is expected that the proposed study will be useful in reducing the symptoms of geriatric depression |
at baseline and after 6months |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2022 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Old age is a phase of a life cycle character characterized by its own developmental issues which are concerned with physical agility and mental acuity, loved one, status and power. At the same time old age is accumulation of wisdom, oppurtunities that on to pass on future generations. One of the task that informs that Erik Erikson view of healthy old age at the time of integrity not a time of despair. In contrast to this group of well old there are sick old , persons with physical and mental disorders or both that impair their ability to function or survive this group is the concern of geriatric psychiatry which deals with the preventing ,diagnosing , treating physiological disorders in older ones. |