A clinical trial to study the efficacy and safety of two drugs ferric carboxymaltose and iron sucrose complex in the treatment of iron deficiency anemia in patients with gynaecological disorders.

A randomised controlled trial on efficacy and safety of intrvenous ferric carboxymaltose verus intravenous iron sucrose complex in the treatment of iron deficiency anemia in women with benign gynaecological disorders.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/03/004461

Enrollment

Registered

2014-03-10

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: null- Iron deficinecy anemia in women with benign gynaecological disorders.

Interventions

Intervention1: Ferric Carboxymaltose: Dose 500mg in 250 ml of sterile 0.9 percent normal saline intravenous over fifteen minutes. Route intravenous Frequency Once a week Duration Two weeks

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with benign gynaecological problems above 18 yrs of age with haemoglobin levels from 6 to 8 g% 2. Peripheral blood smear showing microcytic hypochromic picture with anisopoikilocytosis.

Exclusion criteria

Exclusion criteria: 1)Anemia not due to iron deficiency. 2)Pregnant women will not be included in the study. 3)In cases where iron deficiency anemia is associated with haemolytic/renal or any other primary cause. 4)Anemia with congestive heart failure. 5)Patients who have received parental iron treatment before inclusion in the study. 6)Patients needing blood transfusion during study period will be excluded. 7)Patients with history of allergy to parental iron. 8)Malignancy

Design outcomes

Primary

Measure	Time frame
1)Time taken for improvement of haematological and clinical parameters in both groups. 2)Calculated improvement of haematological parameters in both groups. 3)Subjective improvements in clinical parameters in both the groups. 4)Side effects experienced in both the groups.Timepoint: 1)Time taken for improvement of haematological and clinical parameters in both groups. 2)Calculated improvement of haematological parameters in both groups. 3)Subjective improvements in clinical parameters in both the groups. 4)Side effects experienced in both the groups.	—

Measure

Time frame

1)Time taken for improvement of haematological and clinical parameters in both groups. 2)Calculated improvement of haematological parameters in both groups. 3)Subjective improvements in clinical parameters in both the groups. 4)Side effects experienced in both the groups.Timepoint: 1)Time taken for improvement of haematological and clinical parameters in both groups. 2)Calculated improvement of haematological parameters in both groups. 3)Subjective improvements in clinical parameters in both the groups. 4)Side effects experienced in both the groups.

—

Secondary

Measure	Time frame
no secondary outcomes are included in the study.Timepoint: not applicable	—

Countries

India

Contacts

Public ContactDr Garima Chaudhry

Lady Hardinge Medical College Department of Obstetrics and Gynaecology

graceofganesha@yahoo.com9910207101

Outcome results

None listed

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