Therapeutic evaluation of unani formulation in peptic ulcer single blind, before and after comparison clinical trial

Background and objectives: Peptic ulcer are characterized by the presence of ulcers in any portion of gastrointestinal tract (GIT) exposed to acid in sufficient concentration and duration. Peptic ulcer has been a major threat to the world’s population over the past two centuries, with a high morbidity and substantial mortality. Duodenal ulcer is more common than gastric ulcer; about 75% to 80% of the peptic ulcers are found in the duodenum. The predominant age at which duodenal ulcers occur is between 20 and 50 years, whereas gastric ulcers most commonly occur in patients more than 40 years old. Despite extensive scientific advancements, this disease remains an important clinical setback, largely because of H. pylori infection and widespread use of non-steroidal anti-inflammatory drugs (NSAIDs).The present study was designed with the objective to investigate the efficacy and safety of a poly herbal formulation (comprise of Sibr, Anzaroot, Kundur, Aslussoos and Murmakki) in the management of peptic ulcer.
Methods: This was a single blind, before and after compression interventional trial conducted at National Institute of Unani Medicine Hospital, Bengaluru from February, 2016 to February, 2017. 22 patients were enrolled after screening 117 patients. The test formulation was obtained from classical text of Unani Medicine, Ghinna Munna. 4g of test formulation was given in divided doses orally after meals for 30 days. All the patients were assessed by subjective and objective parameters (UGI Endoscopy, VAS and 5PLS). The SPSS version 16, Wilcoxon rank test, pared proportion test and student’s t test were used to analyze the significance of differences before and after treatment.
Result: Statistical analysis showed highly significant improvement in pain in abdomen and overall symptom relief (p<0.001). The mean number of ulcers before and after treatment was 3.36 ±2.34 and 0.18±0.66 respectively while the mean size of ulcer before and after treatment were10.32±4.58 and 0.64±2.08 respectively. UGIT Endoscopic investigation revealed strongly significant improvement in healing of ulcer (p<0.001).
Conclusion: The study confirmed that the test formulation was significantly effective in relieving symptoms and healing ulcer of upper GIT. No adverse effect was observed during the trial. Hence, it can be concluded that the test formulation is safe and effective. Thus, this trial validates the use of test formulation in the treatment of peptic ulcer.