| CTRI Number |
CTRI/2025/02/079949 [Registered on: 04/02/2025] Trial Registered Prospectively |
| Last Modified On: |
04/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
The Individualized Homoeopathic Medicine in
Improving the Self Esteem in Adolescent Depression |
|
Scientific Title of Study
|
The Efficacy of Individualized Homoeopathic Medicine in
Improving the Self Esteem in Adolescent Depression- A
Double-Blind Randomized Placebo Controlled Trial. |
| 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 DHANARAJ KUMAR RANA |
| Designation |
Associate Professor |
| Affiliation |
National Homoeopathy Research Institute in Mental Health Kottayam |
| Address |
Dept of Psychiatry
National Homoeopathy Research Institute in Mental Health KOTTAYAM
KERALA
Kottayam
KERALA
686532
India |
| Phone |
9496470061 |
| Fax |
|
| Email |
drdkrana123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR R SITHARTHAN |
| Designation |
Principal |
| Affiliation |
National Homoeopathy Research Institute in Mental HealthKOTTAYAM |
| Address |
National Homoeopathy Research Institute in Mental Health KOTTAYAM
KERALA
Kottayam
KERALA
686532
India |
| Phone |
9443203174 |
| Fax |
|
| Email |
sitharthan.r@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR DHANARAJ KUMAR RANA |
| Designation |
Associate Professor |
| Affiliation |
National Homoeopathy Research Institute in Mental HealthKOTTAYAM |
| Address |
Dept of Psychiatry
National Homoeopathy Research Institute in Mental Health KOTTAYAM
KERALA
Kottayam
KERALA
686532
India |
| Phone |
9496470061 |
| Fax |
|
| Email |
drdkrana123@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Homoeopathy Research Institute in Mental Health KOTTAYAM
S.Puram PO 686532 Kerala India
Infrastructure and material support |
|
|
Primary Sponsor
|
| Name |
National Homoeopathy Research Institute in Mental Health |
| Address |
National Homoeopathy Research Institute in Mental Health KOTTAYAM
S Puram PO 686532 Kerala India
|
| 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 DHANARAJ KUMAR RANA |
National Homoeopathy Research Institute in Mental Health |
National Homoeopathy Research Institute in Mental Health
S Puram 686532 Kottayam Kerala India
Kottayam
Kottayam
KERALA |
9496470061
drdkrana123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Homoeopathic Research Institute in Mental Health Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F323||Major depressive disorder, singleepisode, severe with psychotic features, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
Individualized Homoeopathic Medicine in 30 C potency single dose at a time administered oral route during monthly follow up and gradually increasing potencies administered in intervention arm for one year study duration. |
| Comparator Agent |
Placebo |
Placebo as globule sized 40 administer in controlled arm for one year as similar as in interventional arm in single dose oral route and during the monthly follow up |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Both |
| Details |
Subjects of both sexes ages from 10.00 to 19.oo years presenting with depressive
symptoms as per ICD 11 criteria shall be screened with BDI and subjects
scoring between 14 to 69 (mild to severe depression) shall be enrolled for the
study |
|
| ExclusionCriteria |
| Details |
1. Cases currently under anti-depressant
2. Cases with medical or Surgical emergencies
3. BPAD cases with manic hypomanic and mixed states
4. Cases having significant suicide risk (ie attempt plan ideation etc) shall be screened by using
5. C-SSRS, either newly developed or not previously recognized |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in score of self esteem by using Self Esteem Inventory Scale applied at base line 3 6 9 and 12 months in both arm |
One year intervention period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in the symptoms of adolescent depression by using Beck Depression Inventory Scale at base line 6 and 12 months
Change in quality of life WHO QOL using at base line 3 6 and 12 months in both the groups. |
One year intervention period |
|
|
Target Sample Size
|
Total Sample Size="152"
Sample Size from India="152"
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)
|
15/02/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 one of the leading causes of illness and disability among Adolescent population. One important aspect of depression is the Self- Esteem which plays a crucial role in shaping emotional resilience and coping the life challenges during this period. There were only limited studies conducted on this domain of adolescent depression in Homoeopathy. There is a time-demanding need for conducting an in-depth study on Self-esteem among the Adolescent population to explore new interventions to contain this challenge faced by the young population in our country. This proposed placebo-controlled RCT aims to investigate the efficacy of individualized homoeopathic medicine in improving the Self-esteem in Adolescent depression by using scales like SEI, BDI and WHO QOL. The findings of this study will be a new dimension in the management of Adolescent depression |