| CTRI Number |
CTRI/2024/12/077859 [Registered on: 09/12/2024] Trial Registered Prospectively |
| Last Modified On: |
06/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparation of Individualized Homoeopathy and placebo combined with Yoga in management of Mild to Moderate Depressive Disorder in Adult Population. |
|
Scientific Title of Study
|
Comparative Study of Individualized Homoeopathy and Placebo Combined with Yoga in Managing Mild to Moderate Depressive Disorder among Adult Population: A Randomized, Placebo Controlled Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| not applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aaskiran kaur |
| Designation |
PG Scholar |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Department of psychiatry Fourth floor Room no.1 Bakson Homoeopathic Medical College and Hospital
B 36 Knowledge Park I
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
8556085402 |
| Fax |
|
| Email |
aaskirankaur1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kathika Chattopadhyay |
| Designation |
Guide and HOD and Chairperson R&D |
| Affiliation |
Bakson Homoeopathic Medical college and Hospital |
| Address |
Department of psychiatry Fourth floor Room no.1
Bakson Homoeopathic Medical College and Hospital
B 36 Knowledge Park I
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9910860193 |
| Fax |
|
| Email |
dr.kathika@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kathika Chattopadhyay |
| Designation |
Guide and HOD and Chairperson R&D |
| Affiliation |
Bakson Homoeopathic Medical college and Hospital |
| Address |
Department of psychiatry Fourth floor Room no.1
Bakson Homoeopathic Medical College and Hospital
B 36 Knowledge Park I
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9910860193 |
| Fax |
|
| Email |
dr.kathika@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bakson Homoeopathic Medical College And Hospital B36 Knowledge Park 1
Greater Noida
Gautam Buddha Nagar
201310
Uttar Pradesh
India |
|
|
Primary Sponsor
|
| Name |
Principal Bakson Homoeopathic Medical College and Hospital |
| Address |
Principal office
Ground Floor
Room No G22
Bakson Homoeopathic Medical College and Hospital
B 36
Knowledge Park 1
Greater Noida
Gautam Buddha Nagar
201310
Uttar Pradesh
|
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aaskiran kaur |
Bakson Homoeopathic Medical College and Hospital |
Research Outpatient Department (OPD) Room No 7 Ground Floor Bakson Homoeopathic Medical College and Hospital Room no 7 36 B Knowledge Park 1 Greater Noida
201310
Gautam Buddha Nagar
UTTAR PRADESH |
8556085402
aaskirankaur1997@gmail.com |
| Dr Aaskiran Kaur |
Dr. D. P. Rastogi Central Research Institute of Homoeopathy |
Outpatient Department (OPD)Room no 110
Ground Floor A-1/1
sector 24 Noida
201310
Gautam Buddha Nagar
UTTAR PRADESH |
8556085402
aaskirankaur1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Bakson Institutional Ethics Committee |
Approved |
| Kendriya Homoeopathy Anusandhan Parishad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F338||Other recurrent depressive disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicine |
Pill form
30 pill size
oral route of administration
centesimal scale
First dose at the time of
case taking
Subsequent doses according to Follow ups |
| Comparator Agent |
NIL |
Not Applicable |
| Intervention |
Placebo |
Pill form
30 pill size
oral route of administration
Centesimal scale
first dose at the time of
case taking
Subsequent doses according to Follow ups |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Participants included as per DSM-5 diagnostic criteria for depressive disorder.
All genders of an adult age group from 18 years to 59 years.
Participants who are ready to quit previous regimen.
|
|
| ExclusionCriteria |
| Details |
Any form of severe systemic illness and immunocompromised participants will be excluded.
Pregnant and lactating women.
Substance Abuse, Other Mood disorder and other severe psychiatric disorders will be excluded.
Participants who have taken any homoeopathic medicines in the past 3 months.
Participants who refuses to give consent.
Participants with severe and extreme depression will be excluded.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes will be observed on BDI-II Scale.
Changes can be Positive, or Negative or No change. |
15 Months Study
6 Months Enrollment
6 Months Follow up
3 Months Data Analysis
first dose at the time of case taking subsequent doses according to follow ups.
Beck’s Depression inventory scale to be used at the baseline and then 4 weeks,8 weeks,12 weeks upto 24 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
24/12/2024 |
| 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="3"
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
|
This study is to assess the role of Homoeopathic Medicine in the treatment of managing mild to moderate depressive disorder.Sample size is 62.
Double arm Study,15 Months study.
Scale used for assessment Beck’s Depression Inventory Scale (BDI-II).
It is expected to see positive changes in the BDI-II. |