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.

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2021/04/033028

Enrollment

320

Registered

2021-04-22

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K318- Other specified diseases of stomach and duodenum

Interventions

Intervention1: Digeraft: DigeraftTM contain the fixed dose combination (FDC) of sodium alginate 250 mg, sodium bicarbonate 133.5 mg and calcium carbonate 80 mg per 5 mL oral suspension. Each patient w

Eligibility

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
The primary objective of the study is to evaluate safety and tolerability of sodium alginate oral suspension.Timepoint: End of Study	—

Secondary

Measure	Time frame
The secondary objective of the study is to evaluate the effectiveness of sodium alginate oral suspension.Timepoint: day 7, EOS	—

Countries

India

Contacts

Public ContactPraveena V Manglorkar

Seth GS Medical College & KEM Hospital

belhekardrmahesh4@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026