A prospective, open-label, randomized, comparative clinical trial to assess the efficacy of NASO B12 (a novel Methylcobalamin Nasal Spray) or oral B12 supplementation along with standard of care (Iron and Folic Acid supplementation) in the treatment of anemia in women of reproductive age. - NA

Dr Mukulesh Gupta0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年5月29日

试验速览

暂无简介。

•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.

•1. Patient with severe anemia (Hb <7g/dl)
•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.

发起方

Dr Mukulesh Gupta