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Simvastatin in the treatment of idiopathic chronic pancreatitis

A randomized, double blind, multi-centered, placebo controlled study of Simvastatin in the treatment of idiopathic chronic pancreatitis - SIP Study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/01/039260
Enrollment
90
Registered
2022-01-07
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K861- Other chronic pancreatitis

Interventions

Intervention1: Simvastatin: 40mg OD, Orally for 6 months Control Intervention1: Placebo: 40mg OD, Orally for 6 months

Sponsors

SIDS Hospital and Research Centre
Lead Sponsor
SIDS Hospital and Research Centre
Collaborator

Eligibility

Inclusion criteria

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

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Change in the Izbicki pain scoreTimepoint: 6 months

Secondary

MeasureTime frame
Change in levels of Fecal ElastaseTimepoint: 6 months;Change in pancreatitis-related hospital readmissionsTimepoint: 6 months;Change in quality of life score as measured by the QLQ-C30 and QLQ-PAN28(CP)Timepoint: 6 months;Change in serum levels of CRP, IL-6, IL-10, TGF-�²1, MMP-9, TNF-�±, ands-fractalkine Timepoint: 6 months

Countries

India

Contacts

Public ContactMs Archi Patel

SIDS Hospital and Research Center

rmgastro@yahoo.com02612800123

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026