Double-blind, randomized, placebo-controlled, pilot trial of individualized homoeopathic medicines in iron deficiency anaemia
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Blood Hb% and serum ferritin level
研究概览
简要总结
Iron deficiency anemia (IDA) is a problem of high magnitude in developing countries, especially among women and children. Global prevalence is estimated at 24.8% of the population. No trial in homeopathy has yet been up taken to explore the effects of individualized homeopathic medicines (IHMs) in IDA. The objective of this trial was to explore the efficacy of IHMs in the treatment of IDA. A double-blind, randomized, placebo-controlled trial was conducted at the Outpatient departments of Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, India. Sixty participants with IDA were randomized to receive either IHMs (n = 30) or identical-looking placebos (n = 30). Primary outcome measures were blood hemoglobin percentage and serum ferritin level; secondary outcome measure was the fatigue severity scale (FSS) questionnaire scores; all measured at baseline and after 3 months. Group differences and effect sizes (Cohen’s d) were calculated on the intention-to-treat (ITT) sample. Groups were comparable at baseline. Recruitment, retention, and attrition rates were 47.2%, 95%, and 5% respectively. Group differences in serum ferritin level favored IHMs against placebo (P = 0.019), but differences in blood hemoglobin percentage (P = 0.201) and FSS questionnaire scores (P = 0.301) were non-significant. Natrum muriaticum and Sulphur were the most frequently prescribed medicines. Barring some minor events unrelated to interventions, no harm or serious adverse events were recorded in either of the groups. Thus, IHMs acted significantly better than placebos in the treatment of IDA. Independent replications are warranted to substantiate the findings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients suffering from iron deficiency anaemia, Hb% 7-12 gm/dl and serum ferritin level <30 ng/mL, ICD-10: D50.9
- •Both male and female patients
- •Age 18-65 years
- •Patients taking iron supplements will be advised to stop the supplements for 14 days, followed by re-assessment of blood markers in the next enrolment
- •Literate patients; ability to read and write in Bengali and/or English
- •Patients providing written informed consent.
排除标准
- •Patients with haemoglobin less than 7 gm/dl (severe anaemia)
- •Patients who are too sick for consultation
- •Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled systemic illness or life- threatening infections affecting quality of life or any vital organ failure
- •Pregnancy, puerperium and lactation
- •Substance abuse and/or dependence
- •Self-reported immune-compromised state
- •Undergoing homoeopathic treatment for any chronic disease within last 6 months.
结局指标
主要结局
Blood Hb% and serum ferritin level
时间窗: At baseline and after 3 months
次要结局
- Fatigue severity scale (FSS) scores(At baseline and after 3 months)
