Health Condition 1: D539- Nutritional anemia, unspecified
Conditions
Interventions
Intervention1: Methylcobalamin nasal spray 250 μg/spray â??NASO B12 of Troikaa Pharmaceuticals Ltd plus standard of care of IFA (Sugar coated Ferrous sulfate equivalent to elemental Iron 60 mg plus F
Sponsors
Dr Mukulesh Gupta
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female patients of reproductive age (18-40 years) 2. Diagnosed with anaemia (Hb 3. Willing & able to comply with study requirements, e.g. study drug administration and study visit schedule, as indicated by written informed consent provided by the patient. 4. Non-pregnant (supported by negative urine pregnancy test), Non-lactating and willing to maintain reliable birth control throughout the study.
Exclusion criteria
Exclusion criteria: 1. Patient with severe anemia (Hb 2. History of hypersensitivity reaction to study medication. 3. Subjects suspected to have illnesses, where iron supplementation is contraindicated (i.e. history of repeated blood transfusion, known cases of hemolytic anemia, chronic diarrhea, stomach ulcer, heart surgery/prosthetic valves, cancer, tuberculosis; those who are on medications like tetracycline or anticoagulants; and women with excessive bleeding problems). 4. Patients on treatment with drugs that interfere with vitamin B12 assay. 5. Patient using any other nasal medication/device. 6. Patients with any significant nasal pathology, or having chronic nasal symptoms or nasal allergies, or upper respiratory tract infections. 7. Patients having participated in any clinical trial within last 30 days at the time of screening. 8. Any disorder or condition that in the opinion of investigator would prohibit study participation or affect study outcome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the difference in hemoglobin level between the treatment arms at various timepoints.Timepoint: Day 7, Day 14, Day 28, Day 42, Day 56, Day 70, Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the difference in vitamin B12 status between the treatment arms at various timepoints. To compare the difference in other hematological indices (reticulocyte count, RBC count and morphology), serum ferritin and serum folic acid between the treatment arms at various timepoints. Occurrence of any local or systemic adverse eventTimepoint: Day 7, Day 14, Day 28, Day 42, Day 56, Day 70, Day 84 | — |
Countries
India
Contacts
Public ContactDr Mukulesh Gupta
Udyan Health Care Pvt. Ltd
Outcome results
None listed