Clinical Study of combination product to treat Gastro-esophageal Reflux Disease

Not Applicable

Not yet recruiting

Brief Summary: This will be a Prospective, Single-arm, Multi-centric, Post-marketing Surveillance Study in Patients prescribed with FDC of Sodium alginate plus Sodium Bicarbonate plus Calcium Carbonate Therapy for symptoms of GERD.

The study will include 3 evaluation points, visit 1 will screening/baseline visit at day (-10 to 0 days), visit 2 will be Interim visit at week 2 (Day 14 Â± 2 days) and visit 3 will be end of study visit at week 4 (Day 28 Â± 2 days).

Recruitment & Eligibility

Inclusion Criteria

1 Male and non-pregnant female Patients diagnosed with symptoms of GERD aged 18 to 65 years (both inclusive).
2 Patients who are in requirement of FDC therapy of Sodium Alginate, Sodium Bicarbonate and Calcium Carbonate as per Investigator discretion.
3 Patients willing to follow the protocol requirements as evidenced by written informed consent.
4 Patients who having sufficient educational level and proficiency in reading and writing in their local language to be capable of reliably completing study questionnaires, as judged by the physician.

Exclusion Criteria

1 Participated in any clinical trial within 30 days prior to the start of the study.
2 Used histamine-2 receptor blockers, over the counter antacids, anticholinergic, cholinergic, spasmolytic, opiates, sucralfate, prokinetics, antibiotics or bismuth compounds within 14 days prior to the start of the study.
3 Any medical condition which might significantly interfere with the functioning of gastrointestinal tract and according to PI which may interfere with the treatment and makes the patients ineligible for participation in study.
4 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.
5 Patients taking any medications which might interfere with the action of that FDC of sodium alginate + Sodium bicarbonate + calcium carbonate oral suspension prior to the start of the study 6 Female patients who are pregnant or breast-feeding.
7 Patients who are determined to be the risk group for COVID-19.

Primary Outcome Measures

Name	Time	Method
The patientsâ€™ assessment of upper gastrointestinal disorders-symptom severity index (PAGI-SYM) Heartburn/Regurgitation Subscale from baseline, to Day 28	28 Days

Secondary Outcome Measures

Name	Time	Method
1.The patientsâ€™ assessment of upper gastrointestinal disorders-symptom severity index (PAGI-SYM) Heartburn/Regurgitation Subscale from baseline, to Day 14	2.The patientsâ€™ assessment of upper gastrointestinal disorders-symptom severity index (PAGI-SYM) Fullness/ Early Satiety, Nausea/Vomiting, Bloating, Upper abdominal pain and Lower abdominal pain Subscale from baseline, to Day 14 and day 28.

Locations (3): Health Point Hopsital
🇮🇳
Kolkata, WEST BENGAL, India
Shreeji Hospita
🇮🇳
Ahmadabad, GUJARAT, India
Shubham Multispeciality Hopsital
🇮🇳
Ahmadabad, GUJARAT, India
Health Point Hopsital
🇮🇳Kolkata, WEST BENGAL, India
Dr Gauranga Sarkar
Principal investigator
9830165760
drgsmed@gmail.com