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CTRI Number  CTRI/2024/12/078296 [Registered on: 18/12/2024] Trial Registered Prospectively
Last Modified On: 18/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The effectiveness of Homoeopathic medicines and Psychotherapy in Depression of Adolescents 
Scientific Title of Study   A Randomized Controlled Clinical study to assess the effectiveness of Individualized Homoeopathic medicines and Psychotherapy in the treatment of Depression in Adolescents using KADS 11 questionnaire 
Trial Acronym  no trial acronyms 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr BHAVADHARANI B 
Designation  POST GRADUATE SCHOLAR 
Affiliation  Vinayaka mission homoeopathic medical college and hospital 
Address  Department of Psychiatry OPD room no 5C Vinayaka missions homoeopathic medical college and hospital NH47 Sankari main road Seeragapadi Salem Tamil Nadu 636308 India

Salem
TAMIL NADU
636308
India 
Phone  6374764144  
Fax    
Email  bhavabalu2@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr K S LALITHAA 
Designation  Professor and Head of the Department 
Affiliation  Vinayaka missions homoeopathic medical college and hospital 
Address  Department of Psychiatry OPD room no 5C Vinayaka missions homoeopathic medical college and hospital NH47 Sankari main road Seeragapadi Salem Tamil Nadu 636308 India

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 of the Department 
Affiliation  Vinayaka missions homoeopathic medical college and hospital 
Address  Department of Psychiatry OPD room no 5C Vinayaka missions homoeopathic medical college and hospital NH47 Sankari main road Seeragapadi Salem Tamil Nadu 636308 India

Salem
TAMIL NADU
636308
India 
Phone  9940245577  
Fax    
Email  drlalithaagogul@gmail.com  
 
Source of Monetary or Material Support  
Institutional Vinayaka Missions Homoeopathic Medical College and Hospital NH 47 Sankari Main Road Seeragapadi Salem 636308 Tamilnadu 
 
Primary Sponsor  
Name  Vinayaka Missions Homoeopathic Medical College and Hospital 
Address  Department of Psychiatry OPD room no 5C Vinayaka mission homoeopathic medical college and hospital NH47 Sankari main road Seeragapadi Salem Tamil Nadu 636308 India 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr BHAVADHARANI B  Vinayaka Missions Homoeopathic Medical College and Hospital  Department of Psychiatry OPD Room no 5C NH 47 Sankari main road Seeragapadi Salem Tamil Nadu
Salem
TAMIL NADU 		 6374764144

bhavabalu2@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  
Status 
Not Applicable 
 
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 Medicines along with psychotherapy  Homoeopathic medicines are selected based on individualization of the patient. Based on the susceptibility of the patient, the dose is selected. One dose of Medicine is administered via oral route. One dose of medicine is administered orally at the start of treatment and follow up is taken 15 days once. The medicine will be repeated if the symptoms are not relieved and follow up will be followed for a period of six months to evaluate the result of treatment. Along with Homoeopathic medicines, Psychotherapy will be given. 
Comparator Agent  Psychotherapy  Psychotherapy is a significant approach for depression especially in adolescents helping them cope with emotional, behavioral and cognitive difficulties. Early intervention and consistent therapy can lead to significant improvement in mood, function and overall well being for adolescents. Duration : first 3 months 15 days once. According to the patient response either it is given 15days once or monthly once. 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  17.00 Year(s)
Gender  Both 
Details  Patient who are diagnosed of mild and moderate depression based on clinical signs and symptoms. 
 
ExclusionCriteria 
Details  patient with organic mental health disease will be excluded.
patient with psychotic disorder will be excluded
patient with substance use disorder will be excluded
patient with mental retardation will be excluded 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Diagnosis based on Diagnostic and Statistical Manual of Mental disorder Fifth edition DSM 5   At baseline and after 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
It is expected that the proposed study will be usefull in reducing the symptoms of depression using KADS 11 questionnaire  At baseline and after 6 months 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   06/01/2025 
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="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   Dpression is presently one of the leading and burning public health issues in India It impact how you feel think and act as well as your daily activities like sleeping eating and manging your work Adolescence is regarded as transition period from childhood to adulthood Adolescence development on physical cognitive social and psycho sexual level physical decelopment But depression in adolescents is not commonly identified due to its fluctating nature presence of irritability and mood reactivity  with unexplained somatic complaints To combat these challnges Homoeopathy can provides a positive role to promote adolesscent health and well being Homoeopathic medicines for the treatment of depression in adolescents have showed  a significant result with cost effective and sfe administration with no any side effects .  
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