Proteomic Profiling of Patients with Chronic Pancreatitis Following Genistein (Soybean Extract) Administration: A 6-Month Study on Pain-Associated Biomarkers
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1. Evaluation of blood biomarkers related to inflammation, stress, fibrosis, and pancreatic regeneration
研究概览
简要总结
This is a single-center randomized, study designed to assess Proteomic Profiling of Patients on Genistein over 24 weeks with chronic pancreatitis (CP). The primary objective is to to evaluate the proteomic changes and pain outcomes in patients with chronic pancreatitis. Secondary objectives include Change in Health-Related Quality of Life (HRQoL) as assessed by Patient-Reported Outcomes using phone-based application from baseline (week 0) to the end of treatment (week 24), pain score monitoring using VAS, hospital admission rates due to recurrent episodes, and analgesic use comparison between Genistein and placebo arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients (18-65 years) with a diagnosis of chronic pancreatitis.
- •Persistent pancreatic pain (intermittent or continuous).
- •Willingness to comply with trial procedures and provide consent.
排除标准
- •History of autoimmune pancreatitis or biliary pancreatitis.
- •Severe chronic pancreatitis (e.g.,Cambridge Classification Grade IV).
- •Any active infections, recent severe illness, or psychiatric disorders.
- •Concurrent use of other investigational drugs.
结局指标
主要结局
1. Evaluation of blood biomarkers related to inflammation, stress, fibrosis, and pancreatic regeneration
时间窗: 6 months
次要结局
- 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).(6 months)
- Pain Score Assessment: Regular measurement using a validated pain score (e.g., Visual Analogue Scale (VAS) at pre-defined intervals.(6 months)
- Change in analgesic use from baseline (week 0) to end of the treatment (week 24).(6 months)
- Any readmissions for recurrent attacks of pancreatitis from baseline (week 0) to end of the treatment (week 24).(6 months)
研究者
Dr Rajiv Mehta
SIDS hospital and research centre