Investigational Products Methylcobalamin (250mcg/spray) nasal spray and Methylcobalamin 1500 mcg oral tablet .Indication Treatment for Vitamin B12 deficiency in consenting adult subjects

Asian Institute of Gatroentrology0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

研究概览

暂无简介。

•Vitamin B12 level < 200 pg/mL (148 pmol/L)
•General Population
•Patients who are on Metformin (>=1000mg/day) therapy for >= 4 months
•Anaemic patients having hemoglobin level of < 9 g/dL
•Chronic Alcoholic Patients as per DSM V criteria
•Patients on PPI therapy for >= 6 months
•Patients who have undergone Bariatric Surgery (e.g. RYGB surgery/ Mini gastric bypass surgery/ Sleeve Gastrectomy/ Sleeve Gastroplasty etc) OR Gastric Surgery for any indication.
•OR Study population will be any of the following in female population:
•Women on Oral Contraceptive Pills
•Women with Poly Cystic Ovarian Disease(PCOD) on Metformin

•Lactating Women
•Patients with known hypersensitivity or allergies to cobalt and/or vitamin B12 or any component of the study medication.
•Patients with any significant nasal pathology, or having chronic nasal symptoms or nasal allergies or upper respiratory tract infections.
•Patient using any other nasal medication/device.
•Patients having a known diagnosis of severe renal impairment or renal failure. Patients on treatment with drugs which interfere with vitamin B12 assay

发起方

Asian Institute of Gatroentrology