Repurposing Simvastatin in Pancreatitis

Comparative single centered, randomized, open â?? labelled study to evaluate the safety and efficacy of Simvastatin plus Standard of Care and/or Simvastatin plus N â?? acetylcysteine plus Standard of Care compared with only Standard of Care in the patients with idiopathic recurrent pancreatitis and chronic pancreatitis - SNAP-Study

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/03/032454

Enrollment

105

Registered

2021-03-31

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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 Intervention2: Simvastatin, N-acetylcysteine: 40mg OD, Orally for 6 months

600mg BD, orally for 6 months Control Intervention1: Standard of care (anti-oxidants(Î² carotene: 3000 IU, methionine: 550mg, selenium: 200 Âµg, vitamin C 40 mg, vitamin E 10mg)) : BD

for 6 months

Eligibility

Inclusion criteria

Inclusion criteria: At screening, Adult patients ( >18 years of age, at the time of enrolment) with acute recurrent pancreatitis (as per Atlanta Classification) and chronic pancreatitis (Cambridge grade 0 to III); and women of child-bearing potential having confirmed negative pregnancy test result prior to enrolment 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 magnetic resonance cholangiopancreatography (MRCP) or contrast computed tomography 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 5. If the patient had family history of pancreatitis or pancreatic cancer 6. Pregnant or breastfeeding women.

Design outcomes

Primary

Measure	Time frame
1. To measure changes in serum fibro-inflammatory cytokines CRP, IL-6, IL-10, TGF-Î²1, MMP-9, TNF-Î±, and s-fractalkine 2. To measure the change in the quality of life score as measured by the QLQ-C30 and QLQ-PAN28(CP) Timepoint: 6 months	—

Secondary

Measure	Time frame
Change in pancreatitis related readmission Timepoint: 6 months;To measure the change in fecal elastaseTimepoint: 6 months	—

Countries

India

Contacts

Public ContactDr Rajiv Mehta

SIDS Health Care Private Limited

rmgastro@gmail.com02612800000

Outcome results

None listed

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