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.