Health Condition 1: D50- Iron deficiency anemia
Conditions
Interventions
Intervention1: Micronised encapsulated ferric pyrophosphate (MEFP) 30mg capsule: receive Micronised encapsulated ferric pyrophosphate (MEFP) 30mg capsule once a day preferably after breakfast for 12 w
Sponsors
Ambtu Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male with moderate iron deficiency anemia (Hb 7.5 -8.0 gm%; S. Male Ferritin 2. Female with moderate iron deficiency anemia (Hb 7.5 -8.0 gm%; S. Ferritin 3. Age between 18 and 60 years. 4. Willing to give informed consent.
Exclusion criteria
Exclusion criteria: 1. Patient taking any iron supplement already at time of enrolment. 2. History of previous blood transfusion in the last 06 months. 3. Patient with Haemolytic anemia, Haemoglobinopathies, Myelodisplastic Syndromes and Neoplastic disorders. 4.Gastrointestinal surgeries that may impair iron absorption. 5. Patients with severe anemia (less than 6 gms%) requiring parenteral iron and / or blood transfusion. 6. Patients with cardiac, respiratory, neurological, gastro intestinal disease. 7. Female subjects demonstrating a positive pregnancy screen. 8. Patients diagnosed with severe gastritis, peptic ulcer, GI bleed or any other causes of pathological bleeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hb level, MCV, MCH, MCHC and RDW, Serum Ferritin, Serum Transferin LevelsTimepoint: Visit 01: Screening Day 00 Visit 02: Enrolment Day 01 Visit 03: Follow-up Day 45 Visit 04: End of treatment Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Physicians Global Assessment of Response to Therapy (PGART) on a 4-point & Physicans Global Assessment of Tolerability to Therapy (PGATT) on a 4-point scale Timepoint: Visit 01: Screening Day 00 Visit 02: Enrolment Day 01 Visit 03: Follow-up Day 45 Visit 04: End of treatment Day 90 | — |
Countries
India
Contacts
Public ContactDr Suman G
RAJALAKSHMI HOSPITAL
Outcome results
None listed