Helicobacter Pylori InfectionNCT05364619
Qingre Huashi Granules Combined the Modified Dual Therapy for Helicobacter Pylori Infection
A study testing Qingre Huashi Granules combined the modified dual therapy and Bismuth containing quadruple therapy in people with Helicobacter Pylori Infection, run by Peking University First Hospital at 3 sites in China.
Trial summary
This is an open-label, randomized controlled trial. The aim of the study is to evaluate the efficacy and safety of the Qingre Huashi Granules combined the modified dual therapy (or called high dose dual therapy) for Helicobacter pylori infection specifically in geriatric patients, compared with the bismuth containing… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Qingre Huashi Granules combined the modified dual therapy and Bismuth containing quadruple therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 3 sitesChina
- Study dates
- 5 Aug 2022to 31 Dec 2024
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current Helicobacter pylori infection.
- Age ≥ 60 years.
- Diagnosed with syndrome of dampness-heat by Traditional Chinese Medicine.
- Signed the informed consent document.
Who cannot join
- History of Helicobacter pylori treatment.
- History of gastric surgery.
- Allergic to any medications involved in the intervention.
- Sever complications, such as lung dysfunction, uncontrolled hypertension, diabetes, cardiovascular disease, renal dysfunction (eGFR<60ml/min'1.73m2) , malignant tumor，mental disorder.
- Taking medications that may be conflict to the intervention drugs.
- Failing to express symptoms, unwilling to cooperate.
- Taking any antibiotics within a month.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
HUI YE, +86 10 83572351, brightleaf723@163.com
- Active, not recruiting
Beijing Changping Integrative Medicine Hospital
Beijing, Beijing Municipality
- Active, not recruiting
Peking University International Hospital
Beijing, Beijing Municipality
About this study
Official title: Qingre Huashi Granules Combined the Modified Dual Therapy for Helicobacter Pylori Infection Treatment in the Elderly Patient, a Multi-center, Randomized, Controlled Trial
This is an open-label, randomized controlled trial. The aim of the study is to evaluate the efficacy and safety of the Qingre Huashi Granules combined the modified dual therapy (or called high dose dual therapy) for Helicobacter pylori infection specifically in geriatric patients, compared with the bismuth containing quadruple therapy. A total of 160 eligible patients will be enrolled in 4 hospitals. The eradication rate, symptoms, and the adverse events will be recorded and analyzed.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Qingre Huashi Granules combined the modified dual therapy, Bismuth containing quadruple therapy
- Keywords
- Helicobacter pylori, Geriatic, Dual therapy, Bismuth-containing quadruple therapy, Qingre Huashi Decoction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qingre Huashi Granules combined the modified dual therapyDrug
Qingre Huashi Granules combined the modified dual therapy for 14 days
Bismuth containing quadruple therapyDrug
Bismuth containing quadruple therapy for 14 days
| Study group | Role | What they receive |
|---|---|---|
| QHD group | Experimental | Qingre Huashi Granules 1 package twice daily, Rabeprazole 20mg triple daily, Amoxycillin 1g triple daily. The duration is 14 days. Receives: Drug: Qingre Huashi Granules combined the modified dual therapy |
| Control group | Active comparator | Rabeprazole 20mg twice daily, bismuth potassium citrate 220mg twice daily, Amoxycillin 1g twice daily, clarithromycin 500mg twice daily. The duration is 14 days. Receives: Drug: Bismuth containing quadruple therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Helicobacter pylori eradication rate
At the 4th week after the treatment, the 13-carbon urease test was conducted to evaluate the eradication condition. The value of "delta over baseline" <4 was considered to be successful eradication.
Measured: The 4th week after the treatment.
Secondary outcomes (3)
7-point Global Overall Symptom Scale
The 7-point Global Overall Symptom Scale was used to record and evaluate the symptoms. The scale value ranges from 7 to 56. The higher scale means the worse outcome.
Measured: Baseline, the second and sixth week after the treatment, respectively.
Efficacy Scale of the Dampness-heat syndrome
The Scale of the Dampness-heat syndrome was used to record and evaluate the symptoms related to the Traditional Chinese Medicine symptoms. The scale value ranges from 0 to 24. The higher scale means the worse outcome.
Measured: Baseline, the second and sixth week after the treatment, respectively.
Adverse events rate
Any adverse event related to the drugs will be recorded during the entire follow-up period.
Measured: During the follow-up, up to 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start5 Aug 2022
- Primary completion1 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University International Hospital, Beijing Geriatric Hospital, Beijing Changping Integrative Medicine Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05364619
- Sponsor's protocol ID
- ShouFa-2022-2-40711
- Status last verified
- Oct 2022
- First submitted
- 24 Apr 2022
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qingre Huashi Granules Combined the Modified Dual Therapy for Helicobacter Pylori Infection Treatment in the Elderly Patient, a Multi-center, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT05364619
- Acronym / sponsor ID
- ShouFa-2022-2-40711
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, Geriatic, Dual therapy, Bismuth-containing quadruple therapy, Qingre Huashi Decoction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Peking University International Hospital, Beijing Geriatric Hospital, Beijing Changping Integrative Medicine Hospital
- Study start
- 5 Aug 2022 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 May 2022 (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.
This is an open-label, randomized controlled trial. The aim of the study is to evaluate the efficacy and safety of the Qingre Huashi Granules combined the modified dual therapy (or called high dose dual therapy) for Helicobacter pylori infection specifically in geriatric patients, compared with the bismuth containing quadruple therapy. A total of 160 eligible patients will be enrolled in 4 hospitals. The eradication rate, symptoms, and the adverse events will be recorded and analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QHD group | Experimental | Drug: Qingre Huashi Granules combined the modified dual therapyQingre Huashi Granules 1 package twice daily, Rabeprazole 20mg triple daily, Amoxycillin 1g triple daily. The duration is 14 days. |
| Control group | Active comparator | Drug: Bismuth containing quadruple therapyRabeprazole 20mg twice daily, bismuth potassium citrate 220mg twice daily, Amoxycillin 1g twice daily, clarithromycin 500mg twice daily. The duration is 14 days. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Current Helicobacter pylori infection.
- Age ≥ 60 years.
- Diagnosed with syndrome of dampness-heat by Traditional Chinese Medicine.
- Signed the informed consent document.
Key exclusion criteria (7 listed)
- History of Helicobacter pylori treatment.
- History of gastric surgery.
- Allergic to any medications involved in the intervention.
- Sever complications, such as lung dysfunction, uncontrolled hypertension, diabetes, cardiovascular disease, renal dysfunction (eGFR<60ml/min'1.73m2) , malignant tumor，mental disorder.
- Taking medications that may be conflict to the intervention drugs.
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 |
|---|---|---|
| Qingre Huashi Granules combined the modified dual therapyQingre Huashi Granules combined the modified dual therapy for 14 days | Drug | QHD group |
| Bismuth containing quadruple therapyBismuth containing quadruple therapy for 14 days | Drug | Control group |
Primary outcome
Helicobacter pylori eradication rate
Time frame: The 4th week after the treatment.
At the 4th week after the treatment, the 13-carbon urease test was conducted to evaluate the eradication condition. The value of "delta over baseline" <4 was considered to be successful eradication.
3 secondary outcomes
7-point Global Overall Symptom Scale
Time frame: Baseline, the second and sixth week after the treatment, respectively.
Efficacy Scale of the Dampness-heat syndrome
Time frame: Baseline, the second and sixth week after the treatment, respectively.
Adverse events rate
Time frame: During the follow-up, up to 6 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Individual participant dataSharing planned: Undecided
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qingre Huashi Granules combined the modified dual therapy and Bismuth containing quadruple therapy in people with Helicobacter Pylori Infection, run by Peking University First Hospital at 3 sites in China.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HUI YE, Doctor (+86010 83572351, brightleaf723@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Helicobacter pylori eradication rate (time frame: The 4th week after the treatment.). 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 18 Oct 2022.