None listed
Conditions
Interventions
Intervention1: Haemup: Oral uptake for 90 days. 20ml Twice daily.
Control Intervention1: Not Applicable: N.A
Sponsors
Cadila Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female subjects 2. Age between 12-40 years 3. Willingness and ability to participate in study procedures 4. Hb of 11 g/dL or less 5. For postpartum women, 10 days or less postpartum 6.For pregnant women, Gestational age beyond 12 weeks 7. Willingness to provide the writeen informed consent
Exclusion criteria
Exclusion criteria: 1. History of anemia other than iron deficiency anemia 2. Recent blood transfusion 3. Current treatment with myelo suppressive therapy or asthma therapy 4. Intolerance to iron derivatives 5. For postpartum women, the following exclusion criteria will also apply: 1.Significant vaginal bleeding 2. History of blood loss due to delivery being considered for blood transfusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in hemoglobin from baseline to Day 90.Timepoint: Day 0, Day 45, Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in Hb and ferritin from baseline to Day 90Timepoint: Day 0, Day 90;Proportion of participants achieving an Hb level of more than 12 g/dl between baseline and Day 90Timepoint: Day 0, Day 90;Proportion of participants achieving an increase in Hb level of at least 2 g/dl between baseline and Day 90Timepoint: Day 0, Day 90;Safety and adverese event assessmentTimepoint: Day 0, Day 45, Day 90 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Divakars Speciality Hospital
Outcome results
None listed