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.

Not Applicable

Completed

Conditions: Other specified diseases of stomach and duodenum,

Registration Number: CTRI/2021/04/033028

Lead Sponsor: Naxpar Pharma Pvt Ltd

Brief Summary: This is a multicentricpost marketing surveillance study to evaluate the safety and effectiveness ofsodium alginate oral suspension in patients with heartburn and indigestion. Thestudy will be conducted at approximately 8 sites across India. Approximately320 patients suffering with heartburn and indigestion who have been prescribed DigeraftTM as per the approved label in accordance to clinicalpractice and are willing to sign the PAF will be eligible to participate in thestudy.

Since, this is an Surveillance study, no additionaltests or interventions will be suggested; however, investigations done as apart of routine clinical check-up as per investigatorâ€™s routine medicalpractice will be captured.

The study will involveclinical assessments of patients at baseline visit (Day 1, Visit 1) and at orclosest to 7 days after treatment with sodium alginate oral suspension (Visit2).

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 320

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

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.	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.	day 7, EOS

Trial Locations

Locations (5): Ayursundra Super Speciality Hospital
🇮🇳
Kamrup, ASSAM, India
Kanoria Hospital & Research Centre
🇮🇳
Gandhinagar, GUJARAT, India
Seth GS Medical Collee and KEM Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Shubham Sudbhawana Super Speciality Hospital
🇮🇳
Varanasi, UTTAR PRADESH, India
Sri Ramachandra Institute of higher Education and Research
🇮🇳
Chennai, TAMIL NADU, India
Ayursundra Super Speciality Hospital
🇮🇳Kamrup, ASSAM, India
Dr Partha Pratim Kalita
Principal investigator
7399737796
parthapratim.kalita@yahoo.in