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CTRI Number  CTRI/2025/03/083541 [Registered on: 26/03/2025] Trial Registered Prospectively
Last Modified On: 25/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   A Clinical Study to Evaluate the Effectiveness of BJain’s Omeo Anaemia Syrup in Improving Nutritional Anaemia Among Women of Reproductive Age Group. 
Scientific Title of Study   A Single-Site, Single-Arm, Prospective Clinical Study to Assess the Role of BJain’s Omeo Anemia Syrup in Cases of Nutritional Anemia in Females of Reproductive Age Group. 
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 Kiran 
Designation  Research Officer 
Affiliation  BJain Pharmaceuticals Pvt. Ltd. 
Address  A 98, Sector 63, Noida, 201307

Gautam Buddha Nagar
UTTAR PRADESH
201307
India 
Phone  7982487900  
Fax    
Email  research@bjainpharma.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kiran 
Designation  Research Officer 
Affiliation  BJain Pharmaceuticals Pvt. Ltd. 
Address  A 98, Sector 63, Noida, 201307

Gautam Buddha Nagar
UTTAR PRADESH
201307
India 
Phone  7982487900  
Fax    
Email  research@bjainpharma.com  
 
Details of Contact Person
Public Query  
Name  Dr Kiran 
Designation  Research Officer 
Affiliation  BJain Pharmaceuticals Pvt. Ltd. 
Address  A 98, Sector 63, Noida, 201307

Gautam Buddha Nagar
UTTAR PRADESH
201307
India 
Phone  7982487900  
Fax    
Email  research@bjainpharma.com  
 
Source of Monetary or Material Support  
BJain Pharmaceuticals Pvt. Ltd. A-98, Sector 63, Noida, Uttar Pradesh, 201307 
 
Primary Sponsor  
Name  BJain Pharmaceuticals Pvt. Ltd. 
Address  A 98, Sector 63, Noida, 201307 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Kiran  Mother Teresa Senior Secondary School  Room no. 2
Gautam Buddha Nagar
UTTAR PRADESH 		 7982487900

research@bjainpharma.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
GeneBandhu  Approved 
Site approval  No Objection Certificate 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E611||Iron deficiency,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BJain Omeo Anemia Syrup  Dosage: 10 mL, twice daily after meals Duration: 3 months  
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Diagnosed with nutritional anemia with Hb less than 12 g/dL.
Willing to provide informed consent and comply with the study protocol.
 
 
ExclusionCriteria 
Details  Pregnant or breastfeeding women.
Chronic conditions affecting hemoglobin e.g., thalassemia.
Known allergy to the investigational product.
Any past surgeries in 6 months.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in hemoglobin levels.  It will be assessed at 1 month, 2nd month and 3rd month at each follow up.  
 
Secondary Outcome  
Outcome  TimePoints 
Change in fatigue scores using the Fatigue Severity Scale (FSS).  Participants will be assessed at baseline, at 2 months, at the end of the 3-months study period.  
 
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   N/A 
Date of First Enrollment (India)   06/04/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - 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 - Informed Consent Form
    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 [research@bjainpharma.com].

  6. For how long will this data be available start date provided 24-10-2025 and end date provided 24-12-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This clinical study aims to evaluate the effectiveness and safety of BJain’s Omeo Anemia Syrup in improving hemoglobin levels and reducing fatigue in women of reproductive age (18–45 years) with nutritional anemia. Nutritional anemia, primarily caused by iron, folic acid, and vitamin B12 deficiencies, remains a significant public health challenge, affecting approximately 57% of Indian women (NFHS-5, 2019-21).

This single-site, single-arm, prospective study will be conducted over five months at a designated research site. Participants will receive BJain’s Omeo Anemia Syrup (10 mL, twice daily) for three months, with hemoglobin levels and fatigue scores (using the Fatigue Severity Scale) measured at baseline and follow-up visits.

The study aims to assess changes in hemoglobin levels as the primary outcome, with fatigue reduction as a secondary outcome. This research seeks to provide scientific evidence supporting homeopathic interventions for nutritional anemia, offering a potentially well-tolerated alternative to conventional iron supplements.

 
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