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临床试验/CTRI/2020/10/028624
CTRI/2020/10/028624已完成2/3 期

Double-blind, randomized, placebo-controlled, pilot trial of individualized homoeopathic medicines in iron deficiency anaemia

Mahesh Bhattacharyya Homoeopathic Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年10月26日最近更新:

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)

研究者

发起方
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital
申办方类型
Government medical college

研究点 (1)

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