Health Condition 1: D50- Iron deficiency anemia
Conditions
Interventions
Intervention1: Brizfer-XT : Bizfer-XT (Ferrous Bisglycinate 60mg+ Zinc Bisglycinate 15mg + Folic Acid 1mg + Methylcobalamin 500mcg) tablet once daily for 56 days
Sponsors
J. B. chemicals & pharmaceuticals LTD.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female subjects aged 18 to 40 years who are non-pregnant and non-lactating, confirmed by medical history and/or a negative urine pregnancy test. 2. Confirmed diagnosis of iron deficiency anemia (IDA), defined as: a. Hemoglobin (Hb) level between 8 11.9 g/dL, and b. Serum ferritin less than 30 ng/mL, and c. Transferrin saturationless than 20%. 3. Willing to use effective contraception during the study period (if applicable). 4. Willing and able to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Known history of any chronic uncontrolled systemic illnes. 2. Pregnant or lactating women, or those planning pregnancy during the study period 3. Known hypersensitivity or intolerance to iron, folic acid, methylcobalamin, zinc, or any component of the study medication. 4. Anemia due to non-iron deficiency causes, such as: a)Hemolytic anemia b)Aplastic anemia c)Megaloblastic anemia unrelated to iron deficiency d)Thalassemia or other hemoglobinopathies 5. Known history of chronic inflammatory conditions (e.g., rheumatoid arthritis, IBD) that may affect iron metabolism. 6. History of malabsorption syndromes (e.g., celiac disease, bariatric surgery) unless well-controlled. 7. Use of parenteral/oral iron therapy or blood transfusion in the past 12weeks. 8. Current use of other iron supplements or multivitamins containing iron. 9. Participation in another clinical trial within the past 30 days. 10. Any condition that, in the investigator s judgment, may compromise safety, compliance, or study integrity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in hemoglobin (Hb) levels from baseline to the end of treatmentTimepoint: From baseline to end of study day 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in serum ferritin levelsTimepoint: From baseline to end of study day 56;Mean change in serum iron and transferrin saturation (TSAT)Timepoint: From baseline to end of study day 56;Change in fatigue symptoms as measured by the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale.Timepoint: From baseline to end of study day 56;Percentage of participants achieving target Hb levels (Less than or equal to12 g/dL) by end of treatment.Timepoint: At end of study day 56;Incidence of adverse events (AEs) and serious adverse events (SAEs) related to the study drug.Timepoint: From baseline to end of study day 56 | — |
Countries
India
Contacts
Public ContactDr Jay Savai
J. B. chemicals & pharmaceuticals LTD
Outcome results
None listed