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CTRI Number  CTRI/2025/05/087197 [Registered on: 20/05/2025] Trial Registered Prospectively
Last Modified On: 18/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized Factorial Trial 
Public Title of Study   Role of homoeopathy and cognitive behavioural therapy in reducing depression, anxiety and stress in adolescents and young adults 
Scientific Title of Study   A double-blind, double-dummy, randomized, placebo-controlled factorial trial of individualized homoeopathic medicines and cognitive behavioural therapy in reducing depression, anxiety and stress in adolescents and young adults  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sudeshna Mukherjee 
Designation  Associate Professor and Head 
Affiliation  D N De Homoeopathic Medical College and Hospital 
Address  Dept of Forensic Medicine and Toxicology, Psychiatry OPD, 12, Gobinda Khatick Road, Tangra

Kolkata
WEST BENGAL
700046
India 
Phone  7718266965  
Fax    
Email  sudeshnamukh1977@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Subhranil Saha 
Designation  Lecturer 
Affiliation  D N De Homoeopathic Medical College and Hospital 
Address  Dept of Repertory, 12, Gobinda Khatick Road, Tangra

Kolkata
WEST BENGAL
700046
India 
Phone  9836187425  
Fax    
Email  drsubhranilsaha@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Subhasish Ganguly 
Designation  Principal-in-charge and Administrator 
Affiliation  D N De Homoeopathic Medical College and Hospital 
Address  Dept. of Organon of Medicine and Homoeopathic Philosophy, 12, Gobinda Khatick Road, Tangra

Kolkata
WEST BENGAL
700046
India 
Phone  9007263548  
Fax    
Email  dr.subhasish67@gmail.com  
 
Source of Monetary or Material Support  
Dept of Science and Technology & Biotechnology, Govt of West Bengal, Vigyan Chetana Bhavan, 26/B, DD Block, Sector I, Salt Lake, Kolkata 700064, Landmark : City Centre I, Behind ILS Hospital, email : wbdstbt@gmail.com 
 
Primary Sponsor  
Name  Dept of Science and Technology and Biotechnology Govt of West Bengal 
Address  Vigyan Chetana Bhavan, Salt Lake, DD 26/B, Sector I, Kolkata 700064 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
Nil  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sudeshna Mukherjee  D. N. De Homoeopathic Medical College and Hospital  Psychiatry OPD, Dept of FMT, OPD building, 12, Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL 		 7718266965

sudeshnamukh1977@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of D. N. De Homoeopathic 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: F321||Major depressive disorder, singleepisode, moderate, (2) ICD-10 Condition: F419||Anxiety disorder, unspecified, (3) ICD-10 Condition: Z733||Stress, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cognitive Behavioural Therapy plus yoga therapy  Intervention is planned as administering Cognitive Behavioural Therapy along with yoga therapy. Duration of therapy: 6 months 
Comparator Agent  Identical-looking placebo plus yoga therapy  This group will receive placebo, identical in appearance with the verum. Each dose will consist of 4 cane sugar globules no. 40 moistened with 90% v/v ethanol, to be taken orally on clean tongue with empty stomach; dosage and repetition will be maintained depending upon the individual requirement of the cases. All sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. Duration of therapy: 6 months 
Intervention  Individualized Homeopathic Medicines plus Cognitive Behavioural Therapy plus yoga therapy  Intervention is planned as administering indicated homoeopathic medicines in centesimal potencies (CH) along with Cognitive Behavioural Therapy and yoga therapy. Duration of therapy: 6 months 
Intervention  Individualized Homeopathic Medicines plus yoga therapy  Intervention is planned as administering indicated homoeopathic medicines in centesimal potencies (CH). Each dose will consist of 4 cane sugar globules no. 40 moistened with the indicated medicine (preserved in 90% v/v ethanol), to be taken orally on clean tongue on empty stomach; dosage and repetition depending upon the individual requirement of the cases. Patients will be advised to refrain from handling the globules or from eating, drinking, smoking or brushing teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing them. Single individualized medicine will be prescribed on each occasion taking into account presenting symptom totality, clinical history details, constitutional features, miasmatic expressions, repertorization using HOMPATH/RADAR software when required with due consultation of Materia Medica and due consensus among three homoeopaths. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. Provision will be kept to change the medicines or potencies and adjust the dosage in subsequent visits whenever required following the principles of classical homoeopathy and such instances will be compared between groups. Duration of therapy: 6 months 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  a) Cases suffering from depression, stress, and anxiety, diagnosed as per DSM-V criteria.
b) Age between 12 and 30 years
c) Participants of either sex
d) Literate patients’ ability to read and write in English, Hindi, or Bengali.
e) Providing with written informed consent voluntarily 
 
ExclusionCriteria 
Details  a) Severe or very severe depression (HDRS more than 19) with suicide attempt
b) Patients with other psychiatric diseases, e.g., schizophrenia or other psychotic disorders, bipolar affective disorder, schizoaffective disorders, alcohol or other substance abuse, eating disorders, psychosis, mania, hypomania or any other anxiety disorder except panic disorder, personality disorders, history of seizures
c) A clinically significant acute or chronic disease that would hinder regular participation in the study
d) Treatment with antipsychotics, antidepressants, sedatives/hypnotics or mood stabilizers four weeks prior to the screening
e) Complementary or alternative treatment used simultaneously to the study (e.g., acupuncture, phytotherapy, psychotherapy, etc.)
f) Homeopathic treatment for any chronic diseases eight weeks prior to study entry
g) Cases suffering from uncontrolled systemic illness or life-threatening infections
h) Vulnerable population: unconscious, ambulatory, too sick for consultation, differently abled, terminally ill or critically ill patients, mentally incompetent people.
i) Self-reported immune-compromised state
j) Pregnant and puerperal women, lactating mothers
k) Patient under tobacco chewing and/or smoking, alcoholism, and/or any other form(s) of substance abuse and/or dependence
l) Simultaneous participation in any other clinical trial 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
DASS-21 (Depression, Anxiety and Stress Scale – 21)   Baseline, after 3 months, and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
PHQ-9 (Patient Health
Questionnaire)  		 Baseline, every month, up to 6 months 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   02/06/2025 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sudeshnamukh1977@gmail.com].

  6. For how long will this data be available start date provided 01-01-2028 and end date provided 31-12-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Stress, anxiety, and depression are common among adolescents and young adults. This affects their psychological health and may cause a sociocultural imbalance. Recently a cross-sectional survey identified a high prevalence of depression, anxiety, and stress among undergraduate and postgraduate students. The effects of integrating homeopathy with CBT need to be evaluated in a gold-standard design (i.e., a randomized controlled trial) to reduce depression, stress, and anxiety in adolescents and young adults. This research on 200 adolescents and young adults is aimed at reducing depression, anxiety, and stress with homeopathic medicines, cognitive behavioral therapy, or both, using a 6-month, double-blind, double-dummy, randomized, placebo-controlled design at D. N. De Homoeopathic Medical College and Hospital. Assessment will be done by evaluating the DASS-21 score as the primary outcome and the PHQ-9 as the secondary outcome. Comparative analysis will be carried out on the intention-to-treat (ITT) basis to detect group differences. Results will be published in scientific journals. 
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