Alginate vs Sucralfate for GERD Symptomatic Relief

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2026-02-28

Brief Summary

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Gastroesophageal reflux disease (GERD) is a chronic gastrointestinal disorder characterized by the regurgitation of gastric contents into the esophagus.It can also present in an atypical manner such as chest pain, dental erosions, chronic cough, laryngitis, or asthma i.e. extra gastroesophageal symptoms. Sucralfate is a unique anti-ulcer drug and is a basic aluminum salt of sucrose octa-sulfate. It forms a protective layer, enhancing bicarbonate production, demonstrating anti-peptic properties, and fostering tissue growth, regeneration, and repair and it undergoes minimal enteral reabsorption. Alginate is a naturally occurring anionic polymer typically obtained from brown seaweed and has been extensively investigated and used for many biomedical applications, due to its biocompatibility, low toxicity, relatively low cost, and mild gelation by addition of divalent cations such as Ca2+.Both sucralfate and alginate have been in use for the treatment and symptomatic relief of GERD and are well tolerated oral formulations.

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Detailed Description

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Gastroesophageal reflux disease (GERD) is a chronic gastrointestinal disorder characterized by the regurgitation of gastric contents into the esophagus. It is one of the most commonly diagnosed digestive disorders in the young adult population with a prevalence of 20%. Clinically GERD typically manifests with symptoms of heartburn and regurgitation. It can also present in an atypical manner such as chest pain, dental erosions, chronic cough, laryngitis, or asthma i.e. extra gastroesophageal symptoms. Several causative factors have been identified and implicated in the pathogenesis of GERD, like motor abnormalities such as esophageal dysmotility clearance, decrease tone of the lower esophageal sphincter (LES), transient LES relaxation, and delayed gastric emptying, and others are anatomical defects like hiatus hernia and obesity Sucralfate is a unique anti-ulcer drug and is a basic aluminum salt of sucrose octa-sulfate. It forms a protective layer, enhancing bicarbonate production, demonstrating anti-peptic properties, and fostering tissue growth, regeneration, and repair and it undergoes minimal enteral reabsorption. Alginate is a naturally occurring anionic polymer typically obtained from brown seaweed and has been extensively investigated and used for many biomedical applications, due to its biocompatibility, low toxicity, relatively low cost, and mild gelation by addition of divalent cations such as Ca2+.Alginate reacts with gastric acid, forming a gel-like raft that floats on the stomach contents. The raft acts as a physical barrier, preventing acid from reaching the esophagus. Both sucralfate and alginate have been in use for the treatment and symptomatic relief of GERD and are well tolerated oral formulations. This randomized clinical trial will oversee the effects of alginates versus sucralfate for GERD symptomatic relief in combination with proton pump inhibitors.

Conditions

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GERD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Alginate Group

Patient meeting the eligibility criteria will be given two tablespoons before meal twice a day along with PPIS.

Group Type EXPERIMENTAL

Alginate

Intervention Type DRUG

2 Table spoon spoon suspension syrup twice a day before meal.

Sucralfate Group

Patient meeting the eligibility criteria will be given two tablespoons before meal twice a day along with PPIS.

Group Type ACTIVE_COMPARATOR

Sucralfate

Intervention Type DRUG

2 Table spoon spoon suspension syrup twice a day before meal.

Interventions

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Alginate

2 Table spoon spoon suspension syrup twice a day before meal.

Intervention Type DRUG

Sucralfate

2 Table spoon spoon suspension syrup twice a day before meal.

Intervention Type DRUG

Other Intervention Names

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Gaviscon Ulsanic

Eligibility Criteria

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Inclusion Criteria

* All patients having symptoms of severe GERD for more than 3 times /week

Exclusion Criteria

1. Patients with preexisting cardiovascular disorders
2. Patients with chronic kidney or liver diseases
3. Patients with gross abnormalities on upper GI endoscopies e.g.; ulcers, tumors or those with history of upper GI surgery
4. Pregnant and breast feeding
5. Absence of Erosive esophagitis
6. Patients with peptic esophageal ulcers
7. PPI use within 4 weeks

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No