H.Pylori InfectionPhase 2/3NCT03837210
Comparative Anti Helicobacter Pylori Efficacy Assessment of Unani Formulation and Quintuple Regimen
A Phase 2/3 study testing Pylorin in people with H.Pylori Infection, run by Hamdard University.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- H.Pylori Infection
- What is being tested?
- Pylorin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 5 Jan 2017to 10 Jan 2019
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
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.
Read the 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
- 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
- Being tested
- Pylorin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PylorinDrug
Also called Poly Herbal formulation
Poly Herbal formulation
| Study group | Role | What they receive |
|---|---|---|
| Test Drug | Experimental | This group is treated with Herbal formulation. Receives: Drug: Pylorin |
| Control Drug | Active comparator | This group is treated with Quintuple therapy Receives: Drug: Pylorin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication of H. Pylori
Negative Stool antigen for H. pylori
Measured: 4 week duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start5 Jan 2017
- Primary completion10 Jan 2019
- Study completion10 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for H.Pylori InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamdard University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Syed Zahoor Ul Hassan Zaidi, Hamdard University
- Investigators
- Zahoor Zaidi, M.Phil, Principal investigator, Hamdard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03837210
- Sponsor's protocol ID
- zahoor11
- Status last verified
- Feb 2019
- First submitted
- 8 Feb 2019
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Anti Helicobacter Pylori Efficacy Assessment of Unani Formulation and Quintuple Regimen
- ClinicalTrials.gov ID
- NCT03837210
- Acronym / sponsor ID
- zahoor11
- Conditions
- H.Pylori Infection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Hamdard UniversityUniversity, hospital or other
- Study start
- 5 Jan 2017 (actual)
- Primary completion
- 10 Jan 2019 (actual)
- Study completion
- 10 Jan 2019 (actual)
- First posted
- 12 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Drug | Experimental | Drug: PylorinThis group is treated with Herbal formulation. |
| Control Drug | Active comparator | Drug: PylorinThis group is treated with Quintuple therapy |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PylorinAlso: Poly Herbal formulationPoly Herbal formulation | Drug | Control Drug, Test Drug |
Primary outcome
Eradication of H. Pylori
Time frame: 4 week duration
Negative Stool antigen for H. pylori
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zahoor Zaidi, M.Phil principal investigator
Hamdard University
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Pylorin in people with H.Pylori Infection, run by Hamdard University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication of H. Pylori (time frame: 4 week duration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2019.