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Completed

NCT Number: NCT03837210

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

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.

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Key information

Conditions

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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

  • To establish and evaluate scientific and clinical evidence of herbal/eastern formulation and find out the clinical safety and efficacy.
  • To measure the clinical response of herbal formulation in the patients of H.Pylori.

Research Questions

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The individuals suffering from H. pylori infection .
  • Individuals having no previous history of H. pylori infection treatment.
  • Individuals living in Karachi.
  • Individuals with no pathological finding on routine examination.
  • Individuals from either socioeconomic class including lower, middle and higher.
  • Both male and female individuals between 14 to 55 years of age
  • Subjects with informed written consent
  • Patients having no complications regarding other than GIT system.

Exclusion criteria

The following were the reason for excluding the individuals from this trial:

  • Patient with simultaneous physical illness, for example renal dialysis and uncontrolled diabetes mellitus.
  • Individuals having stomach or intestinal surgical history were excluded.
  • Individuals with past record of any herbal or allopathic medication were excluded
  • Individuals with hyper sensitivity history of drug or adverse reaction to any of the study drugs .
  • Females with pregnancy were also excluded for the safety measures
  • Individuals with coma, meningitis, and encephalitis or head injury were also excluded.
  • Hospitalized individuals due to any serious diseases were excluded.
  • Individuals with known poor compliance and history of drug abuse were excluded.

Treatment and study plan

Pylorin

Drug

Poly Herbal formulation

Other names: Poly Herbal formulation

Primary outcomes

  1. Eradication of H. Pylori

    Time frame: 4 week duration

    Negative Stool antigen for H. pylori

Sponsors and collaborators

Lead sponsor

Hamdard University

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 12, 2019
Registry last updated
Feb 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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