Health Condition 1: K861- Other chronic pancreatitis
Conditions
Interventions
Intervention1: Group 1: Genistein-treatment arm: (500mg
twice daily) for 6 months
Control Intervention1: Group 2: Placebo-control arm: (Matching placebo
twice daily) for 6 months
Sponsors
SIDS Hospital and Research Center
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult patients (18-65 years) with a diagnosis of chronic pancreatitis. 2. Persistent pancreatic pain (intermittent or continuous). 3. No history of pancreatic surgery or pancreatic cancer. 4. Willingness to comply with trial procedures and provide consent
Exclusion criteria
Exclusion criteria: 1. History of autoimmune pancreatitis or biliary pancreatitis. 2. Severe chronic pancreatitis (e.g.,Cambridge Classification Grade IV). 3. Any active infections, recent severe illness, or psychiatric disorders. 4. Concurrent use of other investigational drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Evaluation of blood biomarkers related to inflammation, stress, fibrosis, and pancreatic regenerationTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Health-Related Quality of Life (HRQoL) as assessed by Patient-Reported Outcomes using phone-based application from baseline (week 0) to end of treatment (week 24).Timepoint: 6 months;Pain Score Assessment: Regular measurement using a validated pain score (e.g., Visual Analogue Scale (VAS) at pre-defined intervals.Timepoint: 6 months;Change in analgesic use from baseline (week 0) to end of the treatment (week 24).Timepoint: 6 months;Any readmissions for recurrent attacks of pancreatitis from baseline (week 0) to end of the treatment (week 24).Timepoint: 6 months | — |
Countries
India
Contacts
Public ContactDr Samir Vanani
SIDS hospital and research centre
Outcome results
None listed