Helicobacter Pylori [H. Pylori] as the Cause of DiseasesPhase 2/3NCT02004197
Quadruple and Phytomedicine-based Therapies in H. Pylori Infection
A Phase 2/3 study testing Quadruple Allopathic therapy and Pylorex plus in people with Helicobacter Pylori [H. Pylori] as the Cause of Diseases, run by Hafiz Muhammad Asif at 2 sites in Pakistan.
Trial summary
Helicobacter pylori is strongly associated to the development of gastrointestinal disorders. Emerging antibiotic resistance and poor patient compliance of modern therapies has resulted in significant eradication failure. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori [H. Pylori] as the Cause of Diseases
- What is being tested?
- Quadruple Allopathic therapy and Pylorex plus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 2 sitesPakistan
- Study dates
- Jan 2010to Jan 2013
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The patients suffering from H. pylori infection
- Patients having no previous record of treatment against H. pylori infection
- Patients living in Karachi, Rawalpindi and Bahawalpur
- Patients having no pathological complications on routine examination
- All socioeconomic classes were included in the study
- Male and female patients between 15 to 45 years of age
Who cannot join
- there was peptic ulceration, gastrointestinal bleeding or gastric carcinoma
- if history of use of antibiotics, proton-pump inhibitors or bismuth compound in the last one month before test
- any patient found to be allergic or intolerant to therapeutic regimens
- they failed to report for follow-up
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
clinical trial was conducted in high risk areas of Pakistan such as Karachi, Bahawalpur, Islamabad and Rawalpindi at Shifa-Ul-Mulk Memorial Hospital, Hamdrad University Karachi, Bahawalpur Victoria Hospital and Nawaz Salik Hospital respectively
Karachi
Shifa Ul MUlk Memorial Hospital
Karachi
About this study
Official title: Phytomedicine-based and Quadruple Therapies in Helicobacter Pylori Infection. A Comparative Randomized Trial
Helicobacter pylori is strongly associated to the development of gastrointestinal disorders. Emerging antibiotic resistance and poor patient compliance of modern therapies has resulted in significant eradication failure. Clinical trial was conducted to see the efficacy of current quadruple and phytomedicine-based therapies for the eradication of H. pylori infection and relief in its associated symptoms in Pakistan.
- Being tested
- Quadruple Allopathic therapy, Pylorex plus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadruple Allopathic therapyDrug
Also called Omeprazol, Amoxicillin, Metronodazole, TRITEC (ranitidine bismuth citrate)
Pylorex plusDrug
| Study group | Role | What they receive |
|---|---|---|
| Pylorex plus | Experimental | Pylorex plus consisting of medicinal plants. Receives: Drug: Quadruple Allopathic therapy; Drug: Pylorex plus |
| Quadruple therapy | Active comparator | Omeprazole, Amoxicillin, Metronodazole and TRITEC (ranitidine bismuth citrate) Receives: Drug: Quadruple Allopathic therapy; Drug: Pylorex plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
H. pylori eradication rate was the primary endpoint, which was considered to be achieved on the basis of a negative urea breath and stool antigen test four weeks after the end of treatment
Measured: 1 month
Secondary outcomes (1)
The secondary endpoint was the improvement in the clinical features as assessed by an improvement in dyspepsia scores
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startJan 2010
- Primary completionSep 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori [H. Pylori] as the Cause of DiseasesStudies 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
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hafiz Muhammad Asif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hafiz Muhammad Asif, Shifa Ul Mulk Memorial Hospital
- Investigators
- Khan Usman Ghani, Ph. D, Study director, Hamdard University Karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02004197
- Sponsor's protocol ID
- Asif-HP-001
- Status last verified
- Dec 2013
- First submitted
- 20 Aug 2013
- Last updated
- 9 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phytomedicine-based and Quadruple Therapies in Helicobacter Pylori Infection. A Comparative Randomized Trial
- ClinicalTrials.gov ID
- NCT02004197
- Acronym / sponsor ID
- Asif-HP-001
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Hafiz Muhammad AsifUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 9 Dec 2013 (estimated)
- 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 is strongly associated to the development of gastrointestinal disorders. Emerging antibiotic resistance and poor patient compliance of modern therapies has resulted in significant eradication failure. Clinical trial was conducted to see the efficacy of current quadruple and phytomedicine-based therapies for the eradication of H. pylori infection and relief in its associated symptoms in Pakistan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pylorex plus | Experimental | Drug: Quadruple Allopathic therapy, Drug: Pylorex plusPylorex plus consisting of medicinal plants. |
| Quadruple therapy | Active comparator | Drug: Quadruple Allopathic therapy, Drug: Pylorex plusOmeprazole, Amoxicillin, Metronodazole and TRITEC (ranitidine bismuth citrate) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- The patients suffering from H. pylori infection
- Patients having no previous record of treatment against H. pylori infection
- Patients living in Karachi, Rawalpindi and Bahawalpur
- Patients having no pathological complications on routine examination
- All socioeconomic classes were included in the study
Key exclusion criteria (4 listed)
- there was peptic ulceration, gastrointestinal bleeding or gastric carcinoma
- if history of use of antibiotics, proton-pump inhibitors or bismuth compound in the last one month before test
- any patient found to be allergic or intolerant to therapeutic regimens
- they failed to report for follow-up
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 |
|---|---|---|
| Quadruple Allopathic therapyAlso: Omeprazol, Amoxicillin, Metronodazole, TRITEC (ranitidine bismuth citrate) | Drug | Pylorex plus, Quadruple therapy |
| Pylorex plus | Drug | Pylorex plus, Quadruple therapy |
Primary outcome
H. pylori eradication rate was the primary endpoint, which was considered to be achieved on the basis of a negative urea breath and stool antigen test four weeks after the end of treatment
Time frame: 1 month
1 secondary outcome
The secondary endpoint was the improvement in the clinical features as assessed by an improvement in dyspepsia scores
Time frame: 1 month
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 9 Dec 2013.
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.
Khan Usman Ghani, Ph. D study director
Hamdard University Karachi
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Quadruple Allopathic therapy and Pylorex plus in people with Helicobacter Pylori [H. Pylori] as the Cause of Diseases, run by Hafiz Muhammad Asif at 2 sites in Pakistan.
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 6 inclusion and 4 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 9 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
H. pylori eradication rate was the primary endpoint, which was considered to be achieved on the basis of a negative urea breath and stool antigen test four weeks after the end of treatment (time frame: 1 month). 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 9 Dec 2013.