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An 8 week, Investigator Initiated Study to Assess Safety and Effect of Tasiron in the Anaemic Children.

An 8 week, Investigator Initiated Open Label Study to Assess Safety and Efficacy of Tasiron (Fixed Combination of Liposomal Ferric Pyrophosphate - 8 mg, Vitamin C 30 mg, Vitamin B 12-0.45 mcg and Folic Acid- 25mcg) in the Anaemic Children.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/12/022431
Enrollment
100
Registered
2019-12-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D509- Iron deficiency anemia, unspecified

Interventions

None listed

Sponsors

Dr Praveen V Gokhale
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Iron Deficiency Anaemia as 7 less than or equal to Hb less than 10 g dl Ability and willingness to comply with the study protocol Informed Consent given by parent or guardian

Exclusion criteria

Exclusion criteria: Iron deficiency likely or definitely due to blood loss History or evidence of intestinal malabsorption History of prior intravenous iron therapy Major co morbidity such as diarrhoea or a srious chronic medical condition unrelated to iron deficiency apparent on history physical examination High likelihood of suboptimal adherence by parents with study requirements Inability to tolerate oral medications History of birth at less than 30 weeks gestation Other medical or social factors at discretion of treating physician

Design outcomes

Primary

MeasureTime frame
Increase in haemoglobin levels in subjects from baseline in the paediatric subjects of 2 to 7 years of age at the end of 8th weekTimepoint: Increase in haemoglobin levels in subjects from baseline in the paediatric subjects of 2 to 7 years of age at the end of 8th week

Secondary

MeasureTime frame
Number and Percentage of patients with treatment emergent adverse events Compliance check with investigational productTimepoint: Secondary outcome will be assessed or estimated at baseline 4 weeks and 8 weeks

Countries

India

Contacts

Public ContactDr Praveen V Gokhale

Childrens Clinic and Vaccination Centre

pravdr@yahoo.com9820284916

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026