Simvastatin in the treatment of idiopathic chronic pancreatitis

Phase 3

Recruiting

Conditions: Other chronic pancreatitis,

Registration Number: CTRI/2022/01/039260

Lead Sponsor: SIDS Hospital and Research Centre

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 Î²1 (TGF-Î²1) 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 90

Inclusion Criteria

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.

Exclusion Criteria

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.
If there will be a history of active malignancy or pancreatic surgery or chronic myopathy 4.
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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the Izbicki pain score	6 months

Secondary Outcome Measures

Name	Time	Method
Change in quality of life score as measured by the QLQ-C30 and QLQ-PAN28(CP)	6 months
Change in serum levels of CRP, IL-6, IL-10, TGF-Î²1,	MMP-9, TNF-Î±, ands-fractalkine
Change in levels of Fecal Elastase	6 months
Change in pancreatitis-related hospital readmissions	6 months

Trial Locations

Locations (4): Amrita Institute of Medical Sciences
🇮🇳
Ernakulam, KERALA, India
Asian Institute of Gastroenterology
🇮🇳
Hyderabad, TELANGANA, India
SIDS Hospital and Research Centre
🇮🇳
Surat, GUJARAT, India
VGM Hospital
🇮🇳
Coimbatore, TAMIL NADU, India
Amrita Institute of Medical Sciences
🇮🇳Ernakulam, KERALA, India
Dr Rajesh Gopalkrishna
Principal investigator
4846681234
grajesh22@gmail.com