Prospective, open label, multicenter, single arm, post marketing surveillance study for evaluation of safety and efficacy of Amlapitta Mishran Suspension in participants diagnosed with Amlapitta (Functional dyspepsia)

Amlapitta can be correlated to acid peptic disorders like gastritis based on its symptomatology. Gastritis is a condition marked by inflammation, irritation, or erosion of the gastric mucosa. Gastritis is commonly treated based on signs and symptoms by medical practitioners and in majority of cases, they do not rely on endoscopies for diagnosis and treatment. Functional dyspepsia manifests as symptom complex of gastritis in the absence of abnormal endoscopic findings. i.e. endoscopy helps to differentiate gastritis from functional dyspepsia. Globally, about 10 to 30 percent adults suffer from functional dyspepsia. A study reports that 7.6 to 49 percent of Indian population suffers from dyspeptic symptoms. According to the recently revised Rome IV criteria, functional dyspepsia is defined by 1. Persistent or recurring dyspepsia for more than 3 months within the past 6 months; 2. No demonstration of a possible organic cause of the symptoms on endoscopy and 3. No sign that the dyspepsia is relieved only by defecation or of an association with stool irregularities. Functional Dyspepsia (FD) is divided into two subgroups according to cardinal symptoms namely, Postprandial Distress Syndrome (PDS) and Epigastric Pain Syndrome (EPS). The PDS subgroup is defined by symptoms triggered or aggravated by a meal, including postprandial fullness and early satiation and the EPS subgroup is characterized by meal unrelated symptoms, such as epigastric pain and epigastric burning. There can be overlapping PDS and EPS, which is characterized by meal induced dyspeptic symptoms and epigastric pain or burning. Modern medicine offers many drugs or medicaments for the management of Acid Peptic Disorders like gastritis, but their safety may be a cause of concern. Thus, there is need for a new drug with lower side effect profile and good efficacy. Ayurved the ancient Indian system of medicines is a rich database of herbal, mineral and animal origin raw materials or ingredients for the management of acid peptic disorders.

The current study is planned to evaluate the efficacy and safety of Amlapitta Mishran Suspension in participants with Amlapitta (Functional dyspepsia). Amlapitta Mishran Suspension is widely used by Ayurved Practitioners across India in the management of Acid-Peptic Disorders. Amlapitta Mishran Suspension is documented for its anti-ulcer effect in experimental model of indomethacin induced gastric ulcers in rats. Amlapitta Mishran suspension effectively reduced endoscopic gastritis score in the participants and reduced the symptoms of gastritis measured by the Amlapitta Symptom Rating Scale (ASRS), PDS and EPS scores. Amlapitta Mishran Suspension was found to be a safe medication with no adverse events. Amlapitta Mishran Suspension offers the benefits of ingredients like Vasa (Adhatoda vasica), Guduchi (Tinospora cordifolia), Parpata (Fumaria indica), Nimba (Azadirachta indica), Kiratatikta (Swertia chirata), Bhrungaraja (Eclipta alba), Amalaki (Emblica officinalis), Haritaki (Terminalia chebula), Bibhitaka (Terminalia bellirica), Patola (Trichosanthes dioica), Yashti (Glycyrrhiza glabra), and Shouktik Bhasma (Processed Sea Shell).