- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03837210
Comparative Anti Helicobacter Pylori Efficacy Assessment of Unani Formulation and Quintuple Regimen
Study Overview
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
- 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
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Test Drug
This group is treated with Herbal formulation.
|
Poly Herbal formulation
Other Names:
|
Active Comparator: Control Drug
This group is treated with Quintuple therapy
|
Poly Herbal formulation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eradication of H. Pylori
Time Frame: 4 week duration
|
Negative Stool antigen for H. pylori
|
4 week duration
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zahoor Zaidi, M.Phil, Hamdard University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- zahoor11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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