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Homoeopathy for treatment of Iron deficiency anemia in children

Phase 3
Completed
Conditions
Iron deficiency anemia,
Registration Number
CTRI/2019/05/019077
Lead Sponsor
CCRH
Brief Summary

The study will be conducted with an objective to identify the action of Ferrum phosphoricum 3X, Ferrum metallicum3X in iron deficiency anemia. 160 patients in the age group of 12 -14 years of age with Hemoglobin levels ≤ 11.9 gm% and≥ 8 gm%, serum ferritin levels from 10-12µg/L and low mean corpuscular volume (less than 87 fl) will be enrolled in the study. Study is a pilot prospective parallel group, multi-centric single blind randomized trial, where Ferrum drugs (Ferrum phosphoricum 3X, Ferrum Metallicum 3X) will be prescribed as 2 tablets (100 mg), twice a day to children diagnosed with mild to moderate iron deficiency anemia for a period of 3 months.  Outcome will be measured in terms of change in Change in hemoglobin levels after 3 months of treatment and changes in other hematological parameters related to anemia i.e. serum ferritin, serum iron, serum total iron binding capacity.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
640
Inclusion Criteria

Hemoglobin levels ≤ 11.9 gm% and≥ 8 gm%; Serum ferritin levels below 15µg/L ; Low mean corpuscular volume (less than 87 fl).

Exclusion Criteria

Children with Raised CRP levels; Children who have had malaria within 6 weeks prior to the enrollment; Children having worm infestations; Children with reduced Vitamin B12 levels; Children with concurrent heart, liver, renal systemic conditions; Children where parents refuse consent or child refuses assent.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change in hemoglobin levelsAt baseline and at end of 3 months of treatment
Secondary Outcome Measures
NameTimeMethod
Change in Red cell count, PCV, MCV, MCH and MCHC; Change in symptomatology of patients; Incidence of any adverse events during the period of treatmentAt baseline and fortnightly follow ups for 03 months.

Trial Locations

Locations (4)

Dr. D. P. Rastogi Central Research Institute of Homoeopathy, Noida

🇮🇳

Nagar, UTTAR PRADESH, India

National Homoeopathy Research Institute in Mental Health (NHRIMH)

🇮🇳

Kottayam, KERALA, India

Regional Research Institute Guwahati

🇮🇳

Barpeta, ASSAM, India

Regional Research Institute Imphal

🇮🇳

East, MANIPUR, India

Dr. D. P. Rastogi Central Research Institute of Homoeopathy, Noida
🇮🇳Nagar, UTTAR PRADESH, India
Dr Padmalya Rath
Principal investigator
9811704560
drpadmalaya@gmail.com

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