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CTRI Number  CTRI/2025/11/097720 [Registered on: 20/11/2025] Trial Registered Prospectively
Last Modified On: 19/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Role Of Homoeopathic Medicines In Vitamin B12 Deficiency 
Scientific Title of Study   Evaluating The Effectiveness Of Individualized Homoeopathic Medicines In Cases Of Vitamin B12 Deficiency Or Insufficiency; An Open-Label, Prospective, Interventional Study 
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 Bodu Sanghavi 
Designation  Post Graduate Trainee 
Affiliation  National Institute of Homoeopathy, Kolkata 
Address  OPD 18, Department of Homoeopathic Materia Medica, National Institute Of Homoeopathy, Block GE, Sector 3, Salt Lake, Kolkata

Kolkata
WEST BENGAL
700106
India 
Phone  8523866687  
Fax    
Email  sanghavi295@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Prasanta Rath 
Designation  Professor 
Affiliation  National Institute of Homoeopathy, Kolkata 
Address  OPD 18, Department of Homoeopathic Materia Medica, National Institute Of Homoeopathy, Block GE, Sector 3, Salt Lake, Kolkata

Kolkata
WEST BENGAL
700106
India 
Phone  8420924836  
Fax    
Email  drprasantarath09@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Dr Prasanta Rath 
Designation  Professor 
Affiliation  National Institute of Homoeopathy, Kolkata 
Address  OPD 18, Department of Homoeopathic Materia Medica, National Institute Of Homoeopathy, Block GE, Sector 3, Salt Lake, Kolkata

Kolkata
WEST BENGAL
700106
India 
Phone  8420924836  
Fax    
Email  drprasantarath09@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Homoeopathy, Block GE, Sector 3, Salt Lake, Kolkata 700106 
 
Primary Sponsor  
Name  National Institute of Homoeopathy Kolkata 
Address  Block GE, Sector 3, Salt lake, Kolkata, 700106 
Type of Sponsor  Government 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 Bodu Sanghavi  National Institute of Homoeopathy, Kolkata  OPD 18, Department of Homoeopathic Materia Medica, National Institute of Homoeopathy, Block GE, Sector 3, Salt Lake, Kolkata 700106
Kolkata
WEST BENGAL 		 8523866687

sanghavi295@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
National Institute of Homoeopathy, Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E538||Deficiency of other specified B group vitamins,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  INDIVIDUALIZED HOMOEOPATHIC MEDICINES  Individualized Homoeopathic Medicine will be prescribed in potency and dose according to the susceptibility of the patient. GMP certified medicines will be used from the dispensary of NIH, Kolkata. Total duration - 3 months for each patient. A follow up of each patient will be taken on a monthly basis for a period of 3 months and serum vitamin B12 will be checked at baseline and after 3 months. 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  a) Patients with serum Vitamin B12 levels less than or equal to 300 pg/mL
b) Patients between 18-70 years of age, all sexes, all religions and races irrespective of socioeconomic status.
c) Patients willing to take part in the study and fill the respective consent forms.
 
 
ExclusionCriteria 
Details  a) Patients under use of medications affecting vitamin B12 levels – Metformin, proton pump
inhibitors, H2 blockers.
b) Patients under the use of vitamin B12 supplements.
c) Patients with chronic alcoholism or substance abuse.
d) Pregnant and lactating women.
e) Patients having any terminal disease condition. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
For each enrolled case, the serum Vitamin B12 levels will be recorded at baseline
and then again after 3 months using Chemiluminescence Immunoassay (CLIA) technique and its changes
will then be observed and recorded. The efficacy of Individualized Homoeopathic Medicines will be seen
in the cases of Vitamin B12 deficiency or insufficiency. 		 0 month, 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="41"
Sample Size from India="41" 
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)   30/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  30/11/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
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   Vitamin B12 is a water soluble vitamin which contains the mineral cobalt. Hence, compounds with vitamin B12 activity are collectively called cobalamins. It plays a crucial role in several vital processes in the body including development, myelination, and function of the central nervous system, healthy red blood cell formation, and DNA synthesis. Vitamin B12 deficiency refers to a condition in which the serum concentration of vitamin B12 (cobalamin) falls below the normal physiological range, leading to impaired DNA synthesis, haematopoiesis, and neurological function. It is typically defined biochemically as serum vitamin B12 level less than 200 pg/mL and borderline deficiency (insufficiency) 200–300 pg/mL. The primary objective of this study is to compare the changes in serum Vitamin B12 levels in cases of Vitamin B12 deficiency or insufficiency when Individualized Homoeopathic Medicine is used as an intervention over a period of 3 months. A minimum of 41 patients will be enrolled. A follow up of each case will be taken on a monthly basis for a period of 3 months and serum vitamin B12 will be checked at baseline and after 3 months. 
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