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CTRI Number  CTRI/2025/08/093302 [Registered on: 20/08/2025] Trial Registered Prospectively
Last Modified On: 19/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Homeopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical Trial Comparing Homoeopathy and Standard Iron Therapy In Young Adults With Anemia. 
Scientific Title of Study   A Randomized Controlled Trial On The Efficacy Of Homoeopathic Treatment In Comparison To Standard Iron Preperation For Iron Deficiency Anemia In Young Adults 
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 DIVYA S S 
Designation  Junior Resident , Department Of Practice Of Medicine 
Affiliation  White Memorial Homoeo Medical College 
Address  Department Of Practice Of Medicine , White Memorial Homoeo Medical College, Attoor, Veeyanoor

Kanniyakumari
TAMIL NADU
629177
India 
Phone  6238042973  
Fax    
Email  divyassvlrd@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr PRIYA RAJINI R M  
Designation  Associate Professor and Head Of The Department ,Department Of Practice Of Medicine 
Affiliation  White Memorial Homoeo Medical College and Hospital 
Address  Department Of Practice Of Medicine , White Memorial Homoeo Medical College And Hospital , Attoor, Veeyanoor

Kanniyakumari
TAMIL NADU
629177
India 
Phone  7598188281  
Fax    
Email  drpriyarm@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr PRIYA RAJINI R M 
Designation  Associate Professor and Head Of The Department ,Department Of Practice Of Medicine 
Affiliation  White Memorial Homoeo Medical College and Hospital 
Address  Department Of Practice Of Medicine , White Memorial Homoeo Medical College and Hospital ,Attoor, Veeyanoor , Kanniyakumari TAMIL NADU 629177 India

Kanniyakumari
TAMIL NADU
629177
India 
Phone  7598188281  
Fax    
Email  drpriyarm@gmail.com  
 
Source of Monetary or Material Support  
Department Of Practice Of Medicine , White Memorial Homoeo Medical College, Attoor, Veeyanoor PO Kanniyakumari TAMIL NADU 629177 India 
 
Primary Sponsor  
Name  White Memorial Homoeo Medical College And Hospital 
Address  Department Of Practice Of Medicine , White Memorial Homoeo Medical College, Attoor, Veeyanoor PO Kanniyakumari TAMIL NADU 629177 India 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr DIVYA S S  White Memorial Homoeo Medical College and Hospital   Department of Practice Of Medicine White Memorial Homoeo Medical College and Hospital ,Attoor, Veeyanoor.
Kanniyakumari
TAMIL NADU 
6238042973

divyassvlrd@gmail.com 
Dr DIVYA S S  White Mission Hospital  White Mission Hospital, Attoor, Veeyanoor
Kanniyakumari
TAMIL NADU 
6238042973

divyassvlrd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
WHITE MEMORIAL HOMOEO MEDICAL COLLEGE AND HOSPITAL ETHICS COMMITTEE WMHMCH-EC  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 
Comparator Agent  CONVENTIONAL IRON SUPPLEMENTATION  Participants will receive 1 grain weight of Saccharum lactis without any active Homoeopathic medication (placebo), administered with the same frequency. In addition, iron supplementation tablets (100–200 mg) will be administered, with dosage adjusted according to individual clinical requirements.  
Intervention  INDIVIDUALIZED HOMOEOPATHIC MEDICINES  Participants will receive 1 grain weight of Saccharum lactis impregnated with 2 drops of individualized Homoeopathic medicine, administered once weekly. The potency of the Homoeopathic preparation will be either 30C or 200C, depending on the individual case. Additionally, they will receive blank tablets identical in appearance to the allopathic iron tablets. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  24.00 Year(s)
Gender  Both 
Details  Young adults aged 20-24 years.

Confirmed iron deficiency anemia based on hematological markers (Hemoglobin less than 12 g per dL, serum ferritin less than 15 ng per mL).

Residency in the study region (e.g., Kanniyakumari, Tamil Nadu).

Those who are eligible for the trial.
 
 
ExclusionCriteria 
Details  Individuals with hemoglobin levels below 7 g per dL who require urgent intervention, such as Intra venous iron or transfusion.

Individuals who have chronic diseases affecting iron metabolism, iron absorption, iron overload disorders.

Individuals who are taking iron supplements or Homoeopathic remedies for anemia within the past 6 months.

Pregnant or Lactating women.

Female Participants who have irregular menstrual cycles with menorrhagia or pathologic blood loss (to reduce confounding from chronic loss).

Recent major surgery or trauma within the past three months.

Use of medications interfering with iron absorption, such as proton pump inhibitors (PPIs) or chronic corticosteroid use.

Substance abuse or chronic alcoholism.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in serum ferritin level, Symptom resolution  Serum Ferritin - Baseline (Month 0), Month 3 (Week 12), Month 6 (Week 24).
Symptom resolution- Monthly intervals: Month 1 (Week 4), Month 2 (Week 8), Month 3 (Week 12), Month 4 (Week 16), Month 5 (Week 20), Month 6 (Week 24). 
 
Secondary Outcome  
Outcome  TimePoints 
Identification of effective Homoeopathic remedies.
Treatment adherence.
Patient satisfaction.
Incidence of side effects.
Relapse rate 
Identification of effective Homoeopathic remedies-Continuous throughout treatment; Final evaluation at Month 6 (Week 24).
Treatment adherence - Monthly reviews: Month 1–6 (Weeks 4, 8, 12, 16, 20, 24); Final review at Month 6 (Week 24).
Patient satisfaction -Month 3 (Week 12), Month 6 (Week 24).
Incidence of side effects-Continuous monitoring; Monthly reviews: Month 1–6 (Weeks 4, 8, 12, 16, 20, 24).
Relapse rate-Month 9 (Week 36) — 3 months post-intervention. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   13/10/2025 
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="0"
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 - 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

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 [divyassvlrd@gmail.com].

  6. For how long will this data be available start date provided 13-11-2026 and end date provided 13-11-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

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

AIM

To evaluate the efficacy of Homoeopathic treatment versus standard iron preparations in improving iron deficiency anemia and its symptoms using a randomized controlled trial approach.

BACK GROUND 

Iron deficiency anemia (IDA) is a prevalent global health issue among young adults, impacting cognitive function, physical performance, and overall well-being. Homoeopathy offers an individualized approach that may enhance iron absorption and address underlying causes through remedies like Ferrum metallicum and Ferrum phosphoricum. By stimulating the body’s natural healing mechanisms, Homoeopathy presents a potentially gentler alternative to conventional iron therapy.

JUSTIFICATION

While case studies suggest that individualized homoeopathic remedies may improve hemoglobin levels and reduce anemia symptoms, robust randomized trials are needed to establish comparative efficacy. Homoeopathy’s favorable tolerability profile and potential to enhance iron metabolism offer a promising alternative for individuals who experience side effects from conventional iron therapy.

HYPOTHESIS: 

  NULL HYPOTHESIS (Ho): Homoeopathic treatment results in significantly lower improvements compared to Standard iron therapy in managing iron deficiency anemia among young adults.

 ALTERNATIVE HYPOTHESIS (H1): Homoeopathic treatment provides  comparable improvements in iron deficiency anemia outcomes among young adults compared to Standard iron therapy.

METHODOLOGY

This is a prospective, double-blind, randomized controlled trial involving 60 young adults (aged 20–24 years) with confirmed iron deficiency anemia (serum ferritin <15 ng/mL). Participants will be randomly assigned to two groups:

Arm A (Homoeopathic group) will receive individualized Homoeopathic remedies (30C or 200C) weekly.

Arm B (Control group) will receive standard iron supplementation (100–200 mg daily).

Both groups will follow a balanced diet (based on WHO calorie guidelines) and maintain daily diet charts to monitor intake. No additional iron-rich foods will be introduced. 

For IDA due to helminthic infestation, the control group will receive standard treatment; the intervention group will receive individualized Homoeopathic prescriptions based on totality of symptoms.

Follow-up assessments will occur at 3 and 6 months, with an additional 3-month post-treatment observation. Adverse events will be reported to the study guide and ethics committee. Continued care will be provided at White Memorial Homoeo Medical College or White Mission Hospital, Attoor.

 
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