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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alginate Group | Experimental | Patient meeting the eligibility criteria will be given two tablespoons before meal twice a day along with PPIS. |
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| Sucralfate Group | Active Comparator | Patient meeting the eligibility criteria will be given two tablespoons before meal twice a day along with PPIS. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alginate | Drug | 2 Table spoon spoon suspension syrup twice a day before meal. |
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| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life in Reflux and Dyspepsia | This involves questionnaire related to the symptoms and impact on quality of life. The total score is 140, ranging from 0 to 140, the higher the score the worse will be the symptoms. | Before Treatment, At 4 weeks, At 6 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Effects and Tolerability | Using Structured AE Forms and A 5-Point Tolerability Scale | Before Treatment, At 2 weeks, At 4 Weeks |
| Gerd Symptom Severity | Using the 0-4 GERD Symptom Severity Scale, total number of items 20. Total score is 80, ranging from 0 to 80, the higher the score the worse will be the symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Muhammad Hafeez, MBBS | CMH Lahore | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cmh Lahore | Lahore | Punjab Province | 54180 | Pakistan |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000464 | Alginates |
| C007829 | alginate, aluminium hydroxide, magnesium trisilicate, sodium bicarbonate drug combination |
| D013392 | Sucralfate |
| ID | Term |
|---|---|
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D013865 | Thioglycosides |
| D013457 | Sulfur Compounds |
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| Sucralfate | Drug | 2 Table spoon spoon suspension syrup twice a day before meal. |
|
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| Before Treatment, At 2 weeks, At 4 Weeks |
| Quality of Life (QOLRAD) | Using The Validated 0-4-Point Likert QOLRAD Questionnaire, total number of items is 15.Total score is 60, ranging from 0 to 60, the higher the score the worse will be the symptoms. | Before Treatment, At 2 weeks, At 4 Weeks |
| D004066 | Digestive System Diseases |
| D009930 |
| Organic Chemicals |
| D013395 | Sucrose |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D000073893 | Sugars |