A Randomized Controlled Trial On The Efficacy Of Homoeopathic Treatment In Comparison To Standard Iron Preperation For Iron Deficiency Anemia In Young Adults
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in serum ferritin level, Symptom resolution
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 24.00 Year(s)(—)
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in serum ferritin level, Symptom resolution
时间窗: 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).
次要结局
- Identification of effective Homoeopathic remedies.(Treatment adherence.)
研究者
Dr DIVYA S S
White Memorial Homoeo Medical College
