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CTRI Number  CTRI/2025/11/097118 [Registered on: 10/11/2025] Trial Registered Prospectively
Last Modified On: 07/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Homeopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To Study the Effect of Homoeopathic Medicines in Improving Haemoglobin Levels Among Women with Iron Deficiency Anaemia 
Scientific Title of Study   Effectiveness of Aletris Farinosa in Comparison With Individualised Homoeopathic Medicine in Raising The Serum Haemoglobin Levels of Iron Deficiency Anaemia Among 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 Jothykrishna B S 
Designation  Post Graduate Scholar 
Affiliation  Government Homoeopathic Medical College 
Address  Department of Organon of Medicine, Government Homoeopathic Medical College, Iranimuttom, Manacaud P.O., Attukal, Trivandrum-695009

Thiruvananthapuram
KERALA
695009
India 
Phone  6282729015  
Fax    
Email  jothykrishnabs300@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr JeejaS MD HOM  
Designation  Associate Professor 
Affiliation  Government Homoeopathic Medical College 
Address  Department of Organon of Medicine, Government Homoeopathic Medical College, Iranimuttom, Manacaud P.O., Attukal, Trivandrum-695009

Thiruvananthapuram
KERALA
695009
India 
Phone  9447799799  
Fax    
Email  sjeeja68@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jothykrishna B S 
Designation  Post Graduate Scholar 
Affiliation  Government Homoeopathic Medical College 
Address  Department of Organon of Medicine, Government Homoeopathic Medical College, Iranimuttom, Manacaud P.O., Attukal, Trivandrum-695009

Thiruvananthapuram
KERALA
695009
India 
Phone  6282729015  
Fax    
Email  jothykrishnabs300@gmail.com  
 
Source of Monetary or Material Support  
Government Homoeopathic Medical College, Trivandrum, Kerala 695009 
 
Primary Sponsor  
Name  Dr Jothykrishna B S 
Address  Department of Organon of Medicine, Government Homoeopathic Medical College, Trivandrum, Kerala 695009 
Type of Sponsor  Other [Self] 
 
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 Jothykrishna B S  Government Homoeopathic Medical College Iranimuttom Trivandrum   OPNo2&6, Government Homoeopathic Medical College, Iranimuttom, Manacaud, Attukal, Trivandrum 695009
Thiruvananthapuram
KERALA 		 6282729015

jothykrishnabs300@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: D508||Other iron deficiency anemias,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Aletris Farinosa  Aletris Farinosa of different potencies is given to group A in 2 doses once a week through the oral route using sugar of milk as a vehicle. The case will be reviewed at four-week intervals and followed up for six months.  
Comparator Agent  individualised homoeopathic medicine  Individualised homoeopathic medicine is given to group B in 2 doses once a week through the oral route using sugar of milk as a vehicle. The case will be reviewed at four-week intervals and followed up for six months.  
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Persons with clinical signs and symptoms of iron deficiency anaemia.
2. Cases with serum haemoglobin concentration less 11.5 g per dl and more than 7 in
females of age group 15 to 45 years.
3. Mean corpuscular volume less than 90 fl.
4. Mean corpuscular haemoglobin less than 30 pg per dl.
5. Mentzers index value more than 13 
 
ExclusionCriteria 
Details  1. Cases with serious illnesses like chronic kidney disease, malignancy, haemolytic anaemia, etc.
2. Pregnant and lactating women.
3. Cases in which blood donating was done at least 2 weeks from beginning of treatment  
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the effectiveness of Aletris farinosa and individualized
homoeopathic medicine in increasing the value of serum hemoglobin level and
improvement of the FACIT-fatigue score in individuals with iron deficiency anaemia. 		 baseline 3 months and 6 months. 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
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/ Phase 3 
Date of First Enrollment (India)   25/11/2025 
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 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  

This study is a prospective quasi-experimental comparative clinical trial conducted in the outpatient and inpatient departments of Government Homoeopathic Medical CollegeThiruvananthapuram aiming to evaluate and compare the effectiveness of individualised homoeopathic medicine and Aletris farinosa in improving serum haemoglobin levels and FACIT fatigue scores among females of reproductive age 15 to 45 years diagnosed with iron deficiency anaemia. A total of 46 participants meeting the inclusion criteria will be enrolled and allocated into two groups using the randomised sampling method. Group A will receive Aletris farinosa and group B will receive individualised homoeopathic medicine. Both groups will be followed up for six months with assessment of serum Hb values and FACIT fatigue scores. Dietary advice and lifestyle modification will be provided uniformly to all participants. The effectiveness of each treatment will be evaluated based on the improvement of serum Hb concentration and reduction in fatigue scores using appropriate statistical analysis.

 
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