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CTRI Number  CTRI/2026/03/105705 [Registered on: 09/03/2026] Trial Registered Prospectively
Last Modified On: 09/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study to See Whether Low-Dose Amitriptyline Can Improve Persistent Symptoms in Patients After Achalasia Treatment 
Scientific Title of Study   Low-Dose Amitriptyline as Adjunct Therapy for Residual Symptoms Following Peroral Endoscopic Myotomy in Achalasia: A Prospective, Open-Label Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anand Kumar Raghavendran 
Designation  Assistant Professor 
Affiliation  Department of Medical Gastroenterology 
Address  Institute of Gastroenterology Sciences and Organ Transplant
New Thagarupet
Bangalore
KARNATAKA
560002
India 
Phone  9740461517  
Fax    
Email  dranandkumar119@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Anand Kumar Raghavendran 
Designation  Assistant Professor 
Affiliation  Department of Medical Gastroenterology 
Address  Institute of Gastroenterology Sciences and Organ Transplant
New Thagarupet
Bangalore
KARNATAKA
560002
India 
Phone  9740461517  
Fax    
Email  dranandkumar119@gmail.com  
 
Details of Contact Person
Public Query  
Name  Anand Kumar Raghavendran 
Designation  Assistant Professor 
Affiliation  Department of Medical Gastroenterology 
Address  Institute of Gastroenterology Sciences and Organ Transplant
New Thagarupet
Bangalore
KARNATAKA
560002
India 
Phone  9740461517  
Fax    
Email  dranandkumar119@gmail.com  
 
Source of Monetary or Material Support  
Institute of Gastroenterology Sciences and Organ Transplant 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [NA] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Anand Kumar Raghavendran  Institute of Gastroenterology and Organ Transplant  Victoria Hospital Campus New Thagarupet
Bangalore
KARNATAKA 		 09740461517

dranandkumar119@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IGOT Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K220||Achalasia of cardia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Esomeprazole and Amitriptyline  Patients will receive Esomeprazole 40 mg once daily, administered 30 minutes before breakfast. Additionally, they will receive Amitriptyline 10 mg orally once daily at 7 PM. 
Comparator Agent  Esomeprazole Monotherapy  Patient will recieve Esomeprazole 40mg once daily, administered 30 minutes before breakfast. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Clinical response, defined as a reduction of 1 point or greater in the total Eckardt score.  Clinical response, defined as a reduction of 1 point or greater in the total Eckardt score. 
 
Secondary Outcome  
Outcome  TimePoints 
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. 		 12 weeks 
 
Target Sample Size   Total Sample Size="82"
Sample Size from India="82" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/04/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dranandkumar119@gmail.com].

  6. For how long will this data be available start date provided 06-01-2027 and end date provided 06-01-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Peroral endoscopic myotomy (POEM) is a successful treatment for achalasia, but approximately 10 to 40 percent of patients experience residual symptoms like chest pain or dysphagia. These symptoms often occur without objective evidence of obstruction, suggesting visceral hypersensitivity. Low-dose amitriptyline is a neuromodulator with established efficacy in functional esophageal disorders. This randomized trial aims to evaluate if adding low-dose amitriptyline to standard acid suppression therapy improves symptoms better than acid suppression alone. We hypothesize that targeting hypersensitivity will significantly reduce the total Eckardt score over 12 weeks. 
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