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The goal of this clinical trial is to assess the effect of using baclofen along with conventional treatment in improving GERD symptoms. It will also assess the safety of drug baclofen by recording the patient reported adverse events. The main questions it aims to answer are :
Does drug baclofen along with conventional treatment has any effect on patients with GERD symptoms? What medical problems do participants have when taking drug baclofen? Researcher will compare drug baclofen along with conventional treatment to a control group taking placebo along with conventional treatment.
Participants will:
Take drug baclofen 10 milligrams or placebo three times daily along with conventional treatment for 4 weeks. They will visit the hospital after 4 weeks. Their symptoms will be assessed via validated GERD Q questionnaire at baseline and after 4 weeks. Additionally, patient reported adverse events will be documented.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baclofen | Active Comparator | Tablet baclofen 10mg three times will be given along with conventional treatment |
|
| Placebo | Placebo Comparator | Tablet placebo three times daily along with conventional treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baclofen 10mg | Drug | Tablet baclofen 10mg three times daily along with conventional treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of GERD symptoms | The improvement of GERD symptoms will be assessed by GERD Q questionnaire. | At baseline before randomization and at week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of baclofen along with conventional treatment | Effect of baclofen along with conventional treatment including PPI on GERD symptoms will be assessed by GERD Q questionnaire | At week 4 |
| Effect of placebo along with conventional treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adnan Imtiaj Rahul, MBBS | Contact | +8801311286376 | adnanimtiaj@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dhaka Medical College | Recruiting | Dhaka | Bangladesh |
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| ID | Term |
|---|---|
| D001418 | Baclofen |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Placebo |
| Drug |
Tablet placebo three times daily along with conventional treatment |
|
Effect of placebo along with conventional treatment including PPI on GERD symptoms will be assessed by GERD Q questionnaire
| At 4 week |
| Comparison of effects of baclofen and placebo along with conventional treatment | Comparison of effects of baclofen and placebo along with conventional treatment including PPI on GERD symptoms will be assessed by GERD Q questionnaire | At week 4 |
| Adverse events | Patients reported adverse events will be documented | Through the completion of study approximately one year |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |