| 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
|
|
|
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
|
|
|
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. |
|
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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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [divyassvlrd@gmail.com].
- 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.
- 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. |