Health Condition 1: K220- Achalasia of cardia
Conditions
Interventions
Intervention1: Esomeprazole and Amitriptyline: Patients will receive Esomeprazole 40 mg once daily, administered 30 minutes before breakfast. Additionally, they will receive Amitriptyline 10 mg orally
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age greater than or equal to 18 years. 2. Residual symptoms defined as an Eckardt score greater than or equal to 3 persisting at least 2 weeks following technically successful POEM. 3. Normal post-POEM Gastrografin swallow with no delay in esophageal clearance at 5 minutes. 4. No evidence of active inflammation or structural obstruction in upper GI endoscopy and manometry.
Exclusion criteria
Exclusion criteria: 1. Active reflux esophagitis Los Angeles grade B, C, or D on endoscopy. 2. Esophageal stricture. 3. Current use of antidepressants, antipsychotics, or other centrally acting medications. 4. History of major psychiatric illness requiring psychotropic medication. 5. Pregnant or lactating women. 6. Known hypersensitivity to tricyclic antidepressants. 7. Cardiac conduction abnormalities, arrhythmias, or baseline QTc prolongation greater than 450 ms.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response, defined as a reduction of 1 point or greater in the total Eckardt score.Timepoint: Clinical response, defined as a reduction of 1 point or greater in the total Eckardt score. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Eckardt score components: Change in individual components including dysphagia, regurgitation, chest pain, and weight loss. 2. Visceral Sensitivity Index (VSI): Change in VSI score. 3. Psychological symptom scores: Change in PHQ-9 and GAD-7 scores. 4. Adverse effects and Adherence: Incidence and severity of adverse effects related to amitriptyline and treatment adherence assessed by patient self-report and pill count.Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactAnand Kumar Raghavendran
Department of Medical Gastroenterology
Outcome results
None listed