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CTRI Number  CTRI/2022/01/039260 [Registered on: 07/01/2022] Trial Registered Prospectively
Last Modified On: 04/08/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Preventive 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Simvastatin in the treatment of idiopathic chronic pancreatitis 
Scientific Title of Study   A randomized, double blind, multi-centered, placebo controlled study of Simvastatin in the treatment of idiopathic chronic pancreatitis  
Trial Acronym  SIP Study  
Secondary IDs if Any  
Secondary ID  Identifier 
SIDS/SIMVA_SIP/2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajiv Mehta 
Designation  Director & Consultant Gastroenterologist 
Affiliation  SIDS Hospital and Research Center 
Address  Gate no. 3, Vijay Nagar, B/S Nirman Bhavan,
Opp. GandhiCollege, Majura Gate, Ring road,
Surat
GUJARAT
395002
India 
Phone  02612800123  
Fax    
Email  rmgastro@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajiv Mehta 
Designation  Director & Consultant Gastroenterologist 
Affiliation  SIDS Hospital and Research Center 
Address  Gate no. 3, Vijay Nagar, B/S Nirman Bhavan,
Opp. GandhiCollege, Majura Gate, Ring road,
Surat
GUJARAT
395 002
India 
Phone  02612800123  
Fax    
Email  rmgastro@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Ms Archi Patel 
Designation  Clinical Research Coordinator 
Affiliation  SIDS Hospital and Research Center 
Address  Gate no. 3, Vijay Nagar, B/S Nirman Bhavan,
Opp. GandhiCollege, Majura Gate, Ring road,
Surat
GUJARAT
395 002
India 
Phone  9998213106  
Fax    
Email  archirpat@gmail.com  
 
Source of Monetary or Material Support  
Lupin Limited, 3rd Floor, Kalpataru Inspire, Off. Western Expressway Highway, Santacruz (East), Mumbai 400 055, India.  
 
Primary Sponsor  
Name  SIDS Hospital and Research Centre 
Address  Gate no. 3, Vijay Nagar, B/S Nirman Bhavan, Opp. Gandhi College, Majura Gate, Ring road Surat, GUJARAT. 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
SIDS Hospital and Research Centre  Gate no. 3, Vijay Nagar, B/S Nirman Bhavan, Opp. Gandhi College, Majura Gate, Ring road Surat,GUJARAT. 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajesh Gopalkrishna  Amrita Institute of Medical Sciences  Dr Rajesh G, Professor, Department of Gastroenterology, Ponekkara, P.O, Kochi, Kerala. 682041
Ernakulam
KERALA 		 4846681234

grajesh22@gmail.com 
Dr Rupjyoti Talukdar  Asian Institute of Gastroenterology  Department of Medical gastroenterology, Division of pancreas research, Cluster 1, Room no. 4, 6-3-661, Red Rose cafe Ln, Sangeet Nagar, Somajigude, Hyderabad
Hyderabad
TELANGANA 		 4042444222

rupppp@gmail.com 
Dr Rajiv Mehta  SIDS Hospital and Research Centre   Department of Gastroenterology, unit 3, Gate no. 3, Vijay Nagar, B/S Nirman Bhavan, Opp. Gandhi College, Majura Gate, Ring road
Surat
GUJARAT 		 02612800123
02612800170
rmgastro@yahoo.com 
Dr VG Mohan Prasad  VGM Hospital  Dr. V.G.Mohan Prasad, Room no. 1001, 2100, Trichy Rd, Rajalakshmi mills stop, 641005
Coimbatore
TAMIL NADU 		 9750904995

drvgm@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Ethics Committee of Amrita School of Medicine  Approved 
Institutional Ethics Committee Asian Institute of Gastroenterology  Approved 
Institutional Ethics Committee VGM Hospital - Institute of Gastroenterology  Approved 
Surat Institute of Digestive Science Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K861||Other chronic pancreatitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  40mg OD, Orally for 6 months  
Intervention  Simvastatin  40mg OD, Orally for 6 months  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  At screening, Adult patients (>18 years of age, at the time of enrollment) with chronic pancreatitis (Cambridge grade 0 to III); and women of child-bearing potential having confirmed negative pregnancy test result prior to enrollment are eligible for the study.
 
 
ExclusionCriteria 
Details  1. If the patients had major ductal abnormalities (Cambridge Grade IV) or complications of chronic pancreatitis
2. If there will be any evidence of complete pancreas divisum either by MRCP or ERCP.
3. If there will be a history of active malignancy or pancreatic surgery or chronic myopathy
4. If patients were narcotic dependent or had previous exposure to HMG CoA inhibitor therapy
5. If the patient had family history of pancreatitis or pancreatic cancer
6. Pregnant or breast feeding women
7. If patient had any other reversible etiology such as alcohol, smoking, hypertriglyceridemia, autoimmune pancreatitis
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in the Izbicki pain score   6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Change in quality of life score as measured by the QLQ-C30 and QLQ-PAN28(CP)  6 months 
Change in pancreatitis-related hospital readmissions  6 months 
Change in serum levels of CRP, IL-6, IL-10, TGF-β1,
MMP-9, TNF-α, ands-fractalkine
 		 6 months 
Change in levels of Fecal Elastase  6 months 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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   Phase 3 
Date of First Enrollment (India)   20/01/2022 
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="9"
Days="30" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Chronic Pancreatitis (CP) is a progressive inflammatory condition of a pancreas, arising from repeated episodes of acute pancreatitis (AP). Due to recurrent episodes of AP and chronic inflammation, endocrine and exocrine tissues of the pancreas damage resulting in endocrine and exocrine insufficiencies. Simvastatin is the most commonly prescribed 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor, which has a widely accepted tolerability profile. We propose to administer simvastatin 40 mg daily for 6 months in this study because of its Anti- inflammatory and Anti- fibrotic activity.It will Decrease the production of pro-inflammatory cytokines such as tumor necrosis factor alpha (TNF-a), interleukin 1 (IL-1) and interleukin 6 (IL-6). Also, By inhibiting the transforming growth factor β1 (TGF-β1) signaling pathways and interfere with pancreatic stellate cells activation through down regulation of Rho signaling pathways. Participants randomized to Simvastatin-treatment are expected to experience a greater decrease in Izbicki Pain score, improvement of quality of life, fewer episode of pancreatitis related readmissions, a greater decrease in pro-inflammatory and greater increase in anti-inflammatory markers, a greater decrease in fibrotic markers and greater increase in anti-fibrotic markers and a greater increase in fecal elastase.

 
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