NCT03837210

Comparative Anti Helicobacter Pylori Efficacy Assessment of Unani Formulation and Quintuple Regimen

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Hamdard University · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

Helicobacter pylori (H. pylori) is a bacterium its infection is regarded the most common medical condition associated with gastritis1 more over peptic ulcer disease2, gastric adenocarcinoma3 and lymphoma.4control of H pylori infection is thought to be the solution of public health problem.5,6 rate of infection is abating in developed world 7 , but this is slow and people health is challenged, to stop or decrease the new cases is complicated despite the fact that route of transmission are still unclear .8-10 The only option for reducing incidence and prevalence is that screening of masses followed by eradication therapy. A rough estimate propose about 50% of developing country population is affected from infection than the industrialized country. Infected individual may be asymptomatic or some time present with gastroduodenal disease. Prevalence of H pylori is different in developing countries where the adult prevalence reaches up to 80% and in children it is found before the age of 10 years.

Detailed description

Helicobacter pylori (H. pylori) is a bacterium its infection is regarded the most common medical condition associated with gastritis1 more over peptic ulcer disease2, gastric adenocarcinoma3 and lymphoma.4control of H pylori infection is thought to be the solution of public health problem.5,6 rate of infection is abating in developed world 7 , but this is slow and people health is challenged, to stop or decrease the new cases is complicated despite the fact that route of transmission are still unclear .8-10 The only option for reducing incidence and prevalence is that screening of masses followed by eradication therapy. A rough estimate propose about 50% of developing country population is affected from infection than the industrialized country. Infected individual may be asymptomatic or some time present with gastroduodenal disease. Prevalence of H pylori is different in developing countries where the adult prevalence reaches up to 80% and in children it is found before the age of 10 years. Aims and objectives 1. To establish and evaluate scientific and clinical evidence of herbal/eastern formulation and find out the clinical safety and efficacy. 2. To measure the clinical response of herbal formulation in the patients of H.Pylori. Research Questions 1\. has the Unani formulation better effects than quadruple regimen? Hypothesis (H1): Unani has shown better clinical, effects than quadruple regimen. Null Hypothesis (Ho): Quadruple regimen has shown superior clinical, response than Unani formulation. Experimental approaches To check this hypothesis independent variable to dependent variable and perplexing variables will apply by statistical analysis. In this study H. Pylori infection, quadruple regimen are independent variables while signs and symptoms, level of improvement are dependent variables.

Conditions

• H.Pylori Infection

Interventions

Type	Name	Description
DRUG	Pylorin	Poly Herbal formulation

Timeline

• Start date: 2017-01-05
• Primary completion: 2019-01-10
• Completion: 2019-01-10
• First posted: 2019-02-12
• Last updated: 2019-02-12