This study is planned in multiple centers in India, to determine the safety and effectiveness of oral suspension which is a Fixed Dose Combination of sodium alginate 250 mg, sodium bicarbonate 133.5 mg and calcium carbonate 80 mg in the treatment of heartburn and indigestion.
- Conditions
- Health Condition 1: K318- Other specified diseases of stomach and duodenum
- Registration Number
- CTRI/2021/04/033028
- Lead Sponsor
- axpar Pharma Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 320
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
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of the study is to evaluate safety and tolerability of sodium alginate oral suspension.Timepoint: End of Study
- Secondary Outcome Measures
Name Time Method The secondary objective of the study is to evaluate the effectiveness of sodium alginate oral suspension.Timepoint: day 7, EOS