Fixed dose combination of papain and alpha-amylase in patients with functional dyspepsia – A real-world effectiveness study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- To assess the effectiveness of a fixed dose combination of papain and alpha-amylase in
研究概览
简要总结
Functional dyspepsia (FD) is characterized by chronic upper abdominal discomfort, including
epigastric pain or burning sensation, early satiety, or postprandial fullness, without any
identifiable organic cause, affecting a substantial portion of the global population.Current
treatment strategies often involve proton pump inhibitors (PPIs), tricyclic antidepressants (TCA)
or histamine-2 receptor antagonists, and prokinetic agents, yet these approaches do not
universally alleviate symptoms for all patients.The need for alternative therapies is
underscored due to the limitations of conventional medical treatments, including their variable
efficacy and potential side effects leading to patient dissatisfaction.
The combination of papain and alpha-amylase presents a novel therapeutic avenue. Papain, a
proteolytic enzyme, has been shown to aid in protein digestion, while alpha-amylase facilitates
carbohydrate breakdown. This dual action could address the digestive inefficiencies often
experienced by patients with FD, particularly those with enzyme deficiencies. Sathiraju et al.
reported that enzyme supplementation can improve gastrointestinal (GI) function and symptom
relief, suggesting that a fixed-dose combination could enhance treatment outcomes.
Furthermore, the aging population is particularly susceptible to deficiencies of enzymes
responsible for physiological processes, leading to different health issues, the most common
being FD. The combination of papain and alpha-amylase can potentially address these
deficiencies in the aging population frequently experiencing dyspeptic symptoms.6 In addition,
the real-world effectiveness of such combinations is critical to evaluate, as clinical trials often do
not fully capture the complexities of everyday patient experiences. Observational studies have
highlighted the importance of understanding how treatments perform outside controlled
environments, where factors such as adherence, lifestyle, and co-morbidities play significant
roles.
By focusing on a real-world effectiveness study, the proposed research aims to assess the
effectiveness and safety of a fixed-dose combination of papain and alpha-amylase in patients
with FD. The findings could contribute significantly to the field of gastroenterology by offering a
new, effective treatment option for patients suffering from this challenging condition.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either gender aged 18-70 years at screening.
- •Patients diagnosed with FD according to the Rome IV Diagnostic Criteria.
- •Patients who are willing to give informed consent.
排除标准
- •Significant medical history that could jeopardize patient safety.
- •2.Participation in another clinical trial.
- •Use of drugs that interfere with GI motility, except those used to treat FD.
- •Alcoholism or smoking
- •Other GI pathologies (e.g., gastroesophageal reflux, irritable bowel syndrome).
- •Heart disease, chronic hepatic or pancreatic disease, autoimmune disorders, or genetic-metabolic diseases.
结局指标
主要结局
To assess the effectiveness of a fixed dose combination of papain and alpha-amylase in
时间窗: At baseline, 1 week and 2 weeks
patients with Functional Dyspepsia.
时间窗: At baseline, 1 week and 2 weeks
次要结局
- To evaluate the safety of a fixed dose combination of papain and alpha-amylase in patients(with FD.)
研究者
Dr Gurudev S
Navya Multispecialty Hospital