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CTRI Number  CTRI/2025/10/096726 [Registered on: 31/10/2025] Trial Registered Prospectively
Last Modified On: 30/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Does use of brief intervention, a type of motivational interview technique to quit tobacco lead to better pain relief in patients with chronic pancreatitis and tobacco use as compared to standard of care 
Scientific Title of Study   Brief intervention for tobacco addiction in addition to standard of care for pain relief in chronic pancreatitis: A parallel group, superiority, randomized 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  Anshuman Elhence 
Designation  Associate Professor 
Affiliation  Sanjay Gandhi Post Graduate Institute of Medical Sciences 
Address  Department of Gastroenterology, SGPGI Lucknow. Main hospital Building, C-block

Lucknow
UTTAR PRADESH
226014
India 
Phone  08587935706  
Fax    
Email  anshu27790@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Anshuman Elhence 
Designation  Associate Professor 
Affiliation  Sanjay Gandhi Post Graduate Institute of Medical Sciences 
Address  Department of Gastroenterology, SGPGI Lucknow. Main hospital Building, C-block

Lucknow
UTTAR PRADESH
226014
India 
Phone  08587935706  
Fax    
Email  anshu27790@gmail.com  
 
Details of Contact Person
Public Query  
Name  Anshuman Elhence 
Designation  Associate Professor 
Affiliation  Sanjay Gandhi Post Graduate Institute of Medical Sciences 
Address  Department of Gastroenterology, SGPGI Lucknow. Main hospital Building, C-block

Lucknow
UTTAR PRADESH
226014
India 
Phone  08587935706  
Fax    
Email  anshu27790@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research (ICMR) IIRPSG-2025-01-04457 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  Indian Council of Medical Research Ansari Nagar, New Delhi 110029 
Type of Sponsor  Government funding agency 
 
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 
Dr Anshuman Elhence  Sanjay Gandhi Post Graduate Institute of Medical Sciences  Department of Gastroenterology, C-block, academic wing, Room no 3
Lucknow
UTTAR PRADESH 		 08587935706

anshu27790@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee SGPGI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K860||Alcohol-induced chronic pancreatitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Brief intervention  Brief intervention, a non-pharmacological motivational interviewing approach shown to help quit tobacco will be administered by a trained psychiatrist with 5 years training. This will be done using 5 “A” and 5 “R” approach as described in National tobacco dependence treatment guidelines.This will be done during a 20-30 minutes face-to-face session and with follow up counselling done telephonically after 1 week. This will be in addition to standard of care. 
Comparator Agent  Standard of care arm.  The standard of care arm will receive only routine physician advice for quitting tobacco and alcohol along with antioxidants and analgesics as per physician discretion which are part of standard of care of these patients. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Chronic pancreatitis with active tobacco intake (more than 1 cigarette/bidi/pack of gutkha/khaini per day more than 6 months)
2. Age more than 18 years
3. Those who give informed consent
 
 
ExclusionCriteria 
Details  1.Patients with chronic pancreatitis with no tobacco intake or less than 1 bidi/cigarette/pack of khaini/guthka per day)
2.Pancreatic cancer
3.Mass-forming chronic pancreatitis
4.Pre-diagnosed psychiatric comorbidities
5.Pregnancy
6.Patients with chronic pancreatitis and symptomatic peptic ulcer disease/biliary stricture or pseudocyst requiring drainage.
7.Patients with non-dilated pancreatic duct and stones filling the pancreatic duct till body-tail region.
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Difference in Izbicki pain score between the two intervention arms at 6 months  Difference in Izbicki pain score between the two intervention arms at 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of patients with complete pain relief (Izbicki score less than 10)  6 months 
Proportion of patients with partial pain relief (Izbicki score more than 10 but more than 25% decline)  6 months 
Proportion of patients abstinent as per Russell standard  6 months 
Proportion of patients with self-reported abstinence  6 months 
Proportion of patients with more than 50% decline in tobacco intake  6 months 
Time to recidivism from the quit date  follow up of six months 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   30/11/2025 
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="3"
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 - NO
Brief Summary  

Rationale Brief intervention for tobacco cessation is a non-pharmacologic therapy for helping those addicted quit tobacco more effectively than just a usual advice from physician and is recommended form of counselling as per National Tobacco Control Program (NTCP) of India. Most guidelines strongly recommend tobacco cessation for pain relief in chronic pancreatitis (CP). Despite this the role of tobacco cessation in pain control in CP has not been explored prospectively.

Novelty Addition of brief intervention to standard of care for pain management in patients with CP with active tobacco intake will not only provide better pain relief but also align with the NTCP goal of integrating tobacco cessation services with existing infrastructure in gastroenterology outpatient setting.

Objectives: 1) Efficacy of brief intervention(I) for tobacco addiction in addition to standard of care(C) for pain relief (O) in patients with chronic pancreatitis and active tobacco intake (P).2)Efficacy of brief intervention for tobacco addiction in addition to standard of care for abstinence among patients with chronic pancreatitis and active tobacco intake.

Methods Investigator-initiated parallel group, superiority-framework, randomized-controlled trial with an allocation ratio of 1:1. Intervention-arm A will receive brief intervention by a psychiatrist along with standard-of-care for pain relief in CP. Control-arm B will receive only standard-of-care of pain relief in CP which includes routine advice to quit tobacco.

Expected outcomes Pain relief as assessed on Izbicki scale as well as tobacco abstinence rates will be assessed among the two groups. The results will help consolidate the NTCP goals.

 
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