Clinical trial to know the effect of Nasal spray of methylcobalamine versus oral B12 tablet versus standard of care (Iron and Folic Acid supplementation) in anaemic women

INTERVENTION: 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 Folic Acid IP 500 mcg): group I will receive Methylcobalamin nasal spray 250 μg/spray â??NASO B12 plus standard of care (Iron and Folic Acid supplementation) The first seven doses (500 mcg/day through two sprays: one spray in each nostril) will be administered on alternate‐day as follows: Day 1, 3, 5, 7, 9, 11, and 13. Thereafter, weekly dosing on Days 21, 28, 35 and 42, with follow‐ups every two weeks till the end of study. IFA supplementation will be continued for 84 days (Sugar coated Ferrous sulfate equivalent to elemental Iron 60 mg plus Folic Acid IP 500 mcg daily). Control Intervention1: Oral B12 tablets 500 mcg methylcobalamine plus standard of care of IFA (Sugar coated Ferrous sulfate equivalent to elemental Iron 60 mg plus Folic Acid IP 500 mcg): group II patient will receive Oral B12 tablets plus standard of care (Iron and Folic Acid supplementation) Oral B12 tablets (500 mcg/day) on day 1, 3, 5, 7, 9, 11, 13, 21, 28, 35 and 42. IFA supplementation will be continued for 84 days (Sugar coated Ferrous sulfate equivalent to elemental Iron 60 mg plus Folic Acid IP 500 mcg daily). Control Intervention2: Standard of care IFA (Sugar coated Ferrous sulfate equivalent to elemental Iron 60 mg plus Folic Acid IP 500 mcg).: Group III: Control group: Standard of care IFA (Sugar coated Ferrous sulfate equivalent to elemental Iron 60 mg plus Folic Acid IP 500 mcg). Oral IFA daily throughout 84 days. CONDITION: Health Condition 1: D539‐ Nutritional anemia, unspecified PRIMARY OUTCOME: 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 OUTCOME: 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 INCLUSION CRITERIA: 1. Female patients of reproductive age (18‐40 years) 2. Diagnosed with anaemia (Hb <11 g/dL). 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.