| CTRI Number |
CTRI/2024/08/072109 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
07/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic Approach in treating Depression in Cancer patients |
|
Scientific Title of Study
|
Individualised Homoeopathic approach in treating Depression in Cancer patients using Hamilton Depression Rating Scale - A Prospective 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 Namita Rhea Shaji |
| Designation |
PG Scholar |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
4th floor ,Roon No.510 ,College building ,Dept. of Psychiatry ,Sarada Krishna Homoeopathic Medical College Kulasekharam,Kanniyakumari District ,Tamilnadu
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9495282404 |
| Fax |
|
| Email |
namitarheashaji@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subi P.R |
| Designation |
Professor |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
4th floor , Room No.510,College building ,Dept. of Psychiatry ,Sarada Krishna Homoeopathic Medical College Kulasekharam,Kanniyakumari District ,Tamilnadu
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9486863644 |
| Fax |
|
| Email |
drsubinair@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Subi P.R |
| Designation |
Professor |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
4th floor , Room No.510,College building ,Dept. of Psychiatry ,Sarada Krishna Homoeopathic Medical College Kulasekharam,Kanniyakumari District ,Tamilnadu
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9486863644 |
| Fax |
|
| Email |
drsubinair@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sarada Krishna Homoeopathic Medical College Kulasekharam ,Kanniyakumari District ,Tamilnadu Pin - 629161 |
|
|
Primary Sponsor
|
| Name |
Sarada Krishna Homoeopathic Medical College Kulasekharam Kanyakumari District Tamilnadu |
| Address |
Sarada Krishna Homoeopathic Medical College Kulasekharam ,Kanniyakumari District ,Tamilnadu PIN -629161 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 NAMITA RHEA SHAJI |
Sarada Krishna Homoeopathic Medical College Kulasekharam,Kanniyakumari District Tamilnadu |
4th floor , Room No.510,College building ,Dept. of Psychiatry ,4th floor , Room No.510,College building ,Dept. of Psychiatry ,Sarada Krishna Homoeopathic Medical College Kulasekharam,Kanniyakumari District ,Tamilnadu
Kanniyakumari
TAMIL NADU |
9495282404
namitarheashaji@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe,Sarada Krishna Homoeopathic Medical College |
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 |
Homoeopathic Individualized
Medicine. |
The dose will be provided as 30 ,LM potency. Frequency of repetition will be 3 times per day.Route of administration will be oral . Duration of intervention will be one month |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from depression as a co morbidity with cancer.
Patients not changing other medication or treatment procedures during the time of homoeopathic treatment. |
|
| ExclusionCriteria |
| Details |
Patients who are not having depression.
Patients when required to change the ongoing treatment procedure or adding an additional treatment during the time of homoeopathic treatment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of Homoeopathic medicine in managing depression among cancer patients will be assessed by changes in scores of HAM-D Scale. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
18/08/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Depression is the commonest co-morbidity in cancer . Depression leads to poor quality of life and can lead to higher rates of mortality in cancer .Cancer can be life threatening and scary diagnosis ,that acts as source of great distress in patients . High levels of mental distress for sustained periods of time in cancer patients can lead to depression. By giving homoeopathic intervention we can improve the quality of life among cancer patients .In this study ,Hamilton Depression rating scale is used inorder to asses the changes in severity in depression before and after homoeopathic medication .Cancer patients are more likely to experience psychological distress and medical professionals fail to recognize cancer patients who are depressed ,anxious which results in inadequate treatment .And also there is limited evidence for proving the effectiveness of homoeopathic interventions in the treatment of cancer patients with depressive disorders that signifies the importance of this study
|