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CTRI Number  CTRI/2024/02/062641 [Registered on: 14/02/2024] Trial Registered Prospectively
Last Modified On: 28/12/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Ferrum phosphoricum in Anaemia 
Scientific Title of Study   Effectiveness of Ferrum phosphoricum 6x in Increasing Haemoglobin Levels in Anaemia among the Women of Reproductive Age Group: A comparative 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  Madhumita Sadhukhan 
Designation  Research Officer (Homoeopathy) 
Affiliation  Central Council for Research in Homoeopathy 
Address  Dr. Anjali Chatterjee Regional Research Institute for Homoeopathy, Room no: OPD 5, Department: Clinical Research, 50, Rajendra Chatterjee Road Kolkata.

North Twentyfour Parganas
WEST BENGAL
700035
India 
Phone  9331866008  
Fax    
Email  dr.msadhukhan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Madhumita Sadhukhan 
Designation  Research Officer (Homoeopathy) 
Affiliation  Central Council for Research in Homoeopathy 
Address  Dr. Anjali Chatterjee Regional Research Institute for Homoeopathy, Room no: OPD 5, Department: Clinical Research, 50, Rajendra Chatterjee Road Kolkata.

North Twentyfour Parganas
WEST BENGAL
700035
India 
Phone  9331866008  
Fax    
Email  dr.msadhukhan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Madhumita Sadhukhan 
Designation  Research Officer (Homoeopathy) 
Affiliation  Central Council for Research in Homoeopathy 
Address  Dr. Anjali Chatterjee Regional Research Institute for Homoeopathy, Room no: OPD 5, Department: Clinical Research, 50, Rajendra Chatterjee Road Kolkata.

North Twentyfour Parganas
WEST BENGAL
700035
India 
Phone  9331866008  
Fax    
Email  dr.msadhukhan@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Homoeopathy, 61-65 Institutional Area, Opposite D Block, Janakpuri, New Delhi: 110058 
 
Primary Sponsor  
Name  Central Council for Research in Homoeopathy 
Address  61-65 Institutional Area, Opposite D Block, Janakpuri, New Delhi: 110058 
Type of Sponsor  Government funding agency 
 
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 Madhumita Sadhukhan  Dr. Anjali Chatterji Regional Research Institute for Homoeopathy, Kolkata  Room no: OPD 5, Department: Clinical Research, 50, Rajendra Chatterjee Road, Kolkata 700035.
North Twentyfour Parganas
WEST BENGAL 
9331866008

dr.msadhukhan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Dr. Anjali Chatterji Regional Research Institute for Homoeopathy, Kolkata  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D50-D53||Nutritional anemias,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic Medicine, Ferrum Phosphoricum  Ferrum phos 6X will be given on the basis of the presence of an indication of the medicine Ferrum phosphoricum in patients with anemia. All the patients will be given Ferrum phos 6X, 4 tablets OD for 3 months. Trial medicine i.e. Ferrum phos 6X, shall be procured from a GMP-compliant pharmaceutical firm approved by the Council. Medicines will be dispensed in the form of tablets. Consideration of inclusion of the patients as per the presence of any 5 symptoms amongst the 1st and 2nd grade symptoms from The Guiding Symptoms of Our Materia Medica By Constantine Hering. Duration of intervention is 3 months 
Comparator Agent  Homoeopathic Medicine, Ferrum Phosphoricum  Ferrum phos 6X will be given without considering the indication of the medicine Ferrum phosphoricum and will be given as specific to the patients with anemia. All the patients will be given Ferrum phos 6X, 4 tablets OD for 3 months. Trial medicine i.e. Ferrum phos 6X, shall be procured from a GMP-compliant pharmaceutical firm approved by the Council. Medicines will be dispensed in the form of tablets. Consideration of inclusion of the patients as per the presence of any 5 symptoms amongst the 1st and 2nd grade symptoms from The Guiding Symptoms of Our Materia Medica By Constantine Hering. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Female aged 18-45 years,
2. Diagnosed case of Anaemia with Haemoglobin level more than or equal to 8 gm per dl to less than 12 gm per dl
3. Willing to give consent to participate in the study.
 
 
ExclusionCriteria 
Details  1. Patients unable to give informed consent or unwilling to take part in the study.
2. Pregnant and lactating mother
3. Patients who are self-reported immune-compromised.
4. Patients with any self-reported haemoglobinopathies like Thalasaemia, Sickle cell anemia etc.
5. Patients suffering from Anaemia with chronic illnesses like diabetes, cardiac complications, renal failure etc.
6. Patient with diagnosed case of inadequate organ and bone marrow functioning due to aplasia and or malignancy.
7. Patient with psychiatric disorder and or history of substance abuse
8. Patient under homoeopathic treatment for any chronic disease within last 1 month.
9. Patient who are already under Iron supplementation in last 1 month before the enrollment.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Haemoglobin level  At the baseline and at the end of each month till 3 months of follow-up. 
 
Secondary Outcome  
Outcome  TimePoints 
Serum biochemical markers, Serum ferritin, Transferrin, TIBC  At the baseline and at the end of 3rd month 
Quality of life SF36 Score  At the baseline and at the end of every months till 3 months 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   21/02/2024 
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 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  

Anemia is a condition where the number of RBCs or their oxygen-carrying capacity decreases to the extent to meet the physiologic needs, and is conventionally taken as a hemoglobin (Hb) value of less than two standard deviations (SD)than the median value for healthy matched population by age, sex, altitude, smoking, and pregnancy status. Among the various causes, nutritional deficiency, especially iron deficiency, is the most common cause of anemia. Regarding the strategies for correcting IDA (Iron Deficiency Anaemia) at the community level, we have a few options available alone or in combination: education combined with dietary modification or diversification, or both, to improve iron intake and bioavailability; iron supplementation and iron fortification or bio-fortification of foods. Oral iron supplementation has limitations, including side effects, non-compliance, and taking a longer time to correct anemia. Homoeopathy can bridge the gap to reduce the burden of IDA due to its acceptability in the general population and cost-effectiveness. Though there are some encouraging pre-clinical as well as clinical trial, evidences favoring the role of Ferrum phosphoricum in IDA, but studies with proper methodology, larger sample sizes and proper statistical evaluation still miniscule in this subject to draw any definite conclusion. Therefore, a double-blind, randomized controlled trial in a pragmatic setup is required to evaluate the efficacy of FP in IDA over the placebo. But before that, it requires clear clarification whether FP will be useful in anaemia (specific) universally or only when applied according to the indications of this medicine.

 
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