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CTRI Number  CTRI/2025/10/096059 [Registered on: 14/10/2025] Trial Registered Prospectively
Last Modified On: 18/09/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to compare homoeopathic treatment given with the help of Artificial Intelligence and by traditional methods 
Scientific Title of Study   Comparative Clinical Evaluation of Artificial-Intelligence & Neural Language-Models Assisted Prescription versus Conventional Repertory based Prescription in Homoeopathy Assessing Improvement in Patient Reported Outcomes: Single-Blind, Randomized, Exploratory, Pilot Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1328-6198  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Avidipta Hazra 
Designation  Scholar 
Affiliation  Metropolitan Homoeopathic Medical College and Hospital 
Address  Out-patient Department (Room No. 3), Emergency Out-patient Department (Room No.13) and In-patient Departments (Room IPD-M, IPD-F), Hospital Division Ramchandrapur, Sodepur

North Twentyfour Parganas
WEST BENGAL
700110
India 
Phone  6295628901  
Fax    
Email  avidipta.kurchi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Avidipta Hazra 
Designation  Scholar 
Affiliation  Metropolitan Homoeopathic Medical College and Hospital 
Address  Out-patient Department (Room No. 3), Emergency Out-patient Department (Room No.13) and In-patient Departments (Room IPD-M, IPD-F), Hospital Division Ramchandrapur, Sodepur


WEST BENGAL
700110
India 
Phone  6295628901  
Fax    
Email  avidipta.kurchi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Debarsi Das 
Designation  Professor and HOD, Department of Organon of Medicine 
Affiliation  Metropolitan Homoeopathic Medical College and Hospital 
Address  Out-patient Department (Room No. 3), Emergency Out-patient Department (Room No.13) and In-patient Departments (Room IPD-M, IPD-F), Hospital Division Ramchandrapur, Sodepur

North Twentyfour Parganas
WEST BENGAL
700110
India 
Phone  8240821020  
Fax    
Email  drdebarsi@gmail.com  
 
Source of Monetary or Material Support  
Metropolitan Homoeopathic Medical College and Hospital Sodepur, Kolkata, West Bengal, India, 700110 
 
Primary Sponsor  
Name  Metropolitan Homoeopathic Medical College and Hospital 
Address  Ramchandrapur, Sodepur, North Twentyfour Parganas, Kolkata, 700110 
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 Debarsi Das  Metropolitan Homoeopathic Medical College and Hospital  Out-patient Department (Room No. 3), Emergency Out-patient Department (Room No.13) and In-patient Departments (Room IPD-M, IPD-F), Hospital Division Ramchandrapur, Sodepur
North Twentyfour Parganas
WEST BENGAL 		 8240821020

drdebarsi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  AI-NLMs assisted Prescription  After fulfilling inclusion criteria and getting written consent, case taking will be done on a case recording format, which format will be same for both groups. Included patient case data will be entered into an AI-powered NLM model, Which is secure open-access, AI-model developed by expert developer and trained under guidance of expert homoeopathic physicians of India. It has been trained on over 120+ authoritative homoeopathic books-including Materia Medicas, Repertories, Organon of Medicine and philosophy, and Therapeutics-enabling semantic, context-based retrieval of information of disease diagnosis. The system will analyse the narrative of patient complaints, convert them into structured rubrics, and generate possible remedies with rank and score, based on repertory and materia medica data. However, this output will be considered advisory only. The physician will carefully review the suggestions, cross-check the remedies against the complete symptom totality. The final medicine selection from this AI-advised suggestions will always rest with the physician, thereby avoiding the risk of inappropriate prescriptions. 
Comparator Agent  Conventional Repertory-Based Prescription  After fulfilling inclusion criteria and getting written consent, case taking will be done on case recording format. The physician will analyse the symptoms, and manually convert it into repertory rubrics to arrive at a group of possible remedies by conventional computerized repertory software. The final prescription will then be confirmed with materia medica. This reflects the method of individualized homoeopathic prescription as practiced conventionally. The time required for repertory work to remedy selection will be documented for comparison. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients of either sex, 18-65 years of age. 2. Patients seeking homoeopathic treatment. 3. Willingness to participate and provide written informed consent.  
 
ExclusionCriteria 
Details  1. Patients with immediate surgical emergency. 2. Self-declared and/or diagnosed severe uncontrolled systemic diseases such as advanced stage of malignancy, renal failure, decompensated cardiac disease and immune-compromised states. 3. Pregnant and lactating mother. 4. Patients requiring immediate conventional intervention. 5. Patient already under-goes homoeopathy treatment any illness. 6. Patients unwilling or unable to complete follow-up. 7. Patient with unstable mental condition. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Outcome in Relation to Impact on Daily Living (ORIDL)  Baseline, After 4 weeks, After 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
EuroQol Visual Analogue Scale (EQ-VAS)  Baseline, After 4 weeks, After 8 weeks 
Patient Global Impression of Change (PGIC)  Baseline, After 4 weeks, After 8 weeks 
Time taken for remedy selection (recorded in seconds by stopwatches)  Baseline 
 
Target Sample Size   Total Sample Size="362"
Sample Size from India="362" 
Final Enrollment numbers achieved (Total)= "370"
Final Enrollment numbers achieved (India)="370" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   15/01/2026 
Date of Study Completion (India) 30/07/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/07/2026 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

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

  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 - To achieve aims in the approved proposal.

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

  6. For how long will this data be available start date provided 30-11-2026 and end date provided 29-11-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
The findings of this pilot study could provide preliminary insights into the modernization of homoeopathic practice, education, and research. If AI-NLMs assisted prescribing demonstrates trends toward greater efficiency and effectiveness, it may suggest potential for reducing repertorization time, minimizing variability between prescribers, and enhancing patient outcomes. For students and early practitioners, AI-NLMs could serve as an exploratory educational aid, supporting their understanding of repertory and materia medica. Technologically, this trial would offer the first pilot-level systematic evidence on AI integration in homoeopathy, thereby laying the groundwork for larger, more definitive studies. At a broader level, the results may inform future discussions on the possible institutional and policy adoption of AI systems in homoeopathic hospitals, colleges, and research institutes, ultimately contributing to accessibility, credibility, and modernization of practice.
 
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