Multicentre open labelled randomized trial of treatment with ayurvedic formulation and life style modification in patients with Gastroesophageal reflux disease (GERD)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 250
- 试验地点
- 4
- 主要终点
- Proportion of patients with symptomatic response at 8 weeks as assessed by questionnaire (reduction in the symptom score from the pre-treatment value to a score less than equal to 4)
研究概览
简要总结
Gastroesophageal reflux disease (GERD) is defined as reflux of gastric content into the esophagus, resulting in symptoms and/or complications. GERD has a negative impact on quality of life and various activities of daily life such as sleep, diet, and occupation. The cardinal manifestations of GERD are heartburn and sour regurgitation. Proton pump inhibitors are the first line therapy for patients with GERD. However, Long-term use of PPI has been associated with a multitude of adverse events including increased incidence of Clostridium difficile-associated diarrhea and other enteric infections; other adverse events like community-acquired pneumonia, osteoporosis and increased risk of bone fractures, kidney disease, dementia, and micronutrient malabsorption (calcium, magnesium, and vitamin B12) were reported on observational and retrospective studies.
Avipattikar Chruna is a traditional Ayurvedic formulation, mentioned in the Ayurvedic Pharmacopeia of India (Part II, Volume I), and is recommended for use in Amlapitta (Hyperacidity). Avipattikar Chruna has also shown efficacy in animal models of peptic ulcer, and in a single arm open label clinical trial of 133 patients, a combination of sutasekhar rasa (125 mg twice a day orally after principal meals) and Avipattikar choorna (5 g twice a day orally after principal meals) for 04 weeks period led to significant improvement in clinical features(6). Avipattikar Chruna has also been advised by the Ayurveda Standard treatment guidelines by Ministry of Ayush for the treatment of Amlapitta (Hyperacidity). Therefore, Ayurvedic therapy such as Avipattikar Chruna would be cost-effective, safe and associated with minimal side-effects, and could be an effective treatment option for GERD.
The present open labelled RCT is therefore planned to compare the efficacy and tolerance of Avipattikar Chruna versus proton pump inhibitors for the treatment of patients with GERD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
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 with symptomatic GERD (symptoms at least once a week for past 4 weeks) with a questionnaire-based symptom score more than
- •Patients who are off proton pump inhibitor for the past 2 weeks
- •Patients who are off H2 blockers and antacids for past 1 week
- •Ready to participate.
排除标准
- •Patients with alarm symptoms such as weight loss, gastrointestinal bleeding, dysphagia and anaemia
- •Patients who remain symptomatic on two weeks course of standard dose PPI
- •Patients with comorbidities like acute myocardial infarction, chronic kidney disease or chronic liver disease
- •Patients with significant hepatic, renal, endocrine, respiratory, neurologic, or cardiovascular diseases will also be excluded
- •Pregnant, lactating females
- •No history of surgery on the esophagus or stomach
- •Patients with diabetes.
结局指标
主要结局
Proportion of patients with symptomatic response at 8 weeks as assessed by questionnaire (reduction in the symptom score from the pre-treatment value to a score less than equal to 4)
时间窗: 8 weeks
次要结局
- Proportion of patients with endoscopic response (improvement in endoscopic grade of esophagitis by 2 points) and remission (complete endoscopic healing) at 8 weeks(8 weeks)
- Proportion of patients with adverse events in both groups(8 weeks)
研究者
Dr Gautam Sharma
AIIMS New Delhi