Health Condition 1: D509- Iron deficiency anemia, unspecified
Conditions
Interventions
Intervention1: Ferronomic Plus (Lactoferrin 50 mg + Disodium Guanosine 5-Monophosphate 5 mg + Ferrous Bisglycinate 30 mg + Folic Acid 200 mcg Tablets): Subjects will be advised to take one tablet twic
Sponsors
Frimline Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects willing to provide written informed consent. 2. Subjects are willing and able to comply with all the protocol requirements including availability for all scheduled study visits. 3. Subjects with physiological course of pregnancy, singleton pregnancy, gestational age greater than 12 weeks and smaller than 36 weeks at the time of screening visit. 4. Subjects with hemoglobin (Hb) value of smaller than 10 g per dL at screening visit. 5. Subjects with serum iron smaller than 50 mcg per dL and serum ferritin greater than 100 ng per mL at screening visit.
Exclusion criteria
Exclusion criteria: 1. Subjects with history of allergic or hypersensitive reaction or intolerance to any of the ingredients of the study medication. 2. Subjects with gestational (such as hypertension, gestational diabetes) or pre-existent maternal diseases (such as thyroid dysfunctions, pituitary diseases, nutritional diseases, liver pathologies and fetal abnormalities (such as microcephaly, IUGR). 3. Subject has condition or is in a situation which, in the investigator s opinion, may have put the subject at a significant risk, may have confounded study results, or may have interfered significantly with the subject s participation in the study. 4. Subjects with known history of macrocytic or megaloblastic anemia due to vitamin B12 or folate deficiency. 5. Subjects with concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent. 6. Subject has used an investigational formulation in the 3 months prior to screening visit. 7. Subjects with suspected inability or unwillingness to comply with the study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in hemoglobin levels from baseline to end of study visit (Day 60).Timepoint: Visit 1 - Screening or Baseline visit and Visit 4 - End of Study (EOS) visit / Day 60 2 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in hemoglobin levels from baseline to day 30.Timepoint: Visit 1 - Screening or Baseline visit and Visit 3 - Follow up visit / Day 30 2 days.;Change in serum ferritin, serum iron and total iron-binding capacity (TIBC) levels from baseline to day 30 and day 60.Timepoint: Visit 1 - Screening or Baseline visit, Visit 3 - Follow up visit / Day 30 2 days and Visit 4 - End of Study (EOS) visit / Day 60 2 days.;Adverse events and serious adverse events reported during the study.Timepoint: Throughout the study.;Changes in clinical laboratory parameters from baseline to end of study visit.Timepoint: Visit 1 - Screening or Baseline visit and Visit 4 - End of Study (EOS) visit / Day 60 2 days. | — |
Countries
India
Contacts
Public ContactDr Harsh Shah
Clinwave Research Pvt. Ltd.
Outcome results
None listed