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.
Phase 4
- Conditions
- Health Condition 1: null- Iron deficinecy anemia in women with benign gynaecological disorders.
- Registration Number
- CTRI/2014/03/004461
- Lead Sponsor
- ady Hardinge Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 60
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)Time taken for improvement of haematological and clinical parameters in both groups. <br/ ><br>2)Calculated improvement of haematological parameters in both groups. <br/ ><br>3)Subjective improvements in clinical parameters in both the groups. <br/ ><br>4)Side effects experienced in both the groups.Timepoint: 1)Time taken for improvement of haematological and clinical parameters in both groups. <br/ ><br>2)Calculated improvement of haematological parameters in both groups. <br/ ><br>3)Subjective improvements in clinical parameters in both the groups. <br/ ><br>4)Side effects experienced in both the groups.
- Secondary Outcome Measures
Name Time Method no secondary outcomes are included in the study.Timepoint: not applicable