Homoeopathic treatment of anaemia due to lo level of iron in body

Phase 2/3

Completed

Conditions: Iron deficiency anemia, unspecified,

Registration Number: CTRI/2020/10/028624

Lead Sponsor: Mahesh Bhattacharyya Homoeopathic Medical College and Hospital

Brief Summary: 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 (Cohenâ€™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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

Patients suffering from iron deficiency anaemia, Hb% 7-12 gm/dl and serum ferritin level <30 ng/mL, ICD-10: D50.9 2.
Both male and female patients 3.
Age 18-65 years 4.
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 5.
Literate patients; ability to read and write in Bengali and/or English 6.
Patients providing written informed consent.

Exclusion Criteria

Patients with haemoglobin less than 7 gm/dl (severe anaemia) 2.
Patients who are too sick for consultation 3.
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 4.
Pregnancy, puerperium and lactation 5.
Substance abuse and/or dependence 6.
Self-reported immune-compromised state 7.
Undergoing homoeopathic treatment for any chronic disease within last 6 months.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood Hb% and serum ferritin level	At baseline and after 3 months

Secondary Outcome Measures

Name	Time	Method
Fatigue severity scale (FSS) scores	At baseline and after 3 months

Trial Locations

Locations (1): Mahesh Bhattacharyya Homoeopathic Medical College and Hospital
🇮🇳
Haora, WEST BENGAL, India
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital
🇮🇳Haora, WEST BENGAL, India
Saleema Naaz Tabassum
Principal investigator
9007743845
farheenomar41@gmail.com