A Multicentric, Post marketing Surveillance Study to Evaluate the Safety and Effectiveness of Fixed Dose Combination of Sodium Alginate 250 mg, Sodium Bicarbonate 133.5 mg and Calcium Carbonate 80 mg Oral Suspension in Patients with Heartburn and Indigestion

axpar Pharma Pvt Ltd0 个研究点目标入组 320 人开始时间: 待定最近更新: 2024年3月4日

试验速览

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•1.Male and female patients above 18 years upto 60 years of age
•2.Patients who are suffering with heartburn and indigestion and are prescribed DigeraftTM as per the approved label in accordance to clinical practice
•3.Patients willing to sign patient authorization form (PAF)

•1.Patients with highly restricted salt/sodium diet e.g. in some cases of congestive cardiac failure, renal impairment, hypertension, and edema states; patients with known cases of hypercalcemia, nephrocalcinosis, and recurrent calcium containing renal calculi; patients with known or suspected hypersensitivity to the active substance or any of the excipients; or any other conditions or diseases that an investigator considers it as inappropriate to enter the study as per the approved label.
•2.Patients taking any medications which might interfere with the action of sodium alginate oral suspension prior to the start of the study
•3.Female patients who are pregnant or nursing mothers
•4.Patients who are determined to be the risk group for COVID-19

发起方

axpar Pharma Pvt Ltd