Helicobacter Pylori InfectionNCT07159412
Huazhi Rougan Granule as an Add-On Therapy for H. Pylori Infection With Metabolic-associated Steatohepatitis
A study testing Vonoprazan-amoxicillin combined with Huazhi Rougan Granule in people with Helicobacter Pylori Infection and Metabolic-associated Steatohepatitis, run by Nanjing First Hospital, Nanjing Medical University.
Trial summary
This study employed a double-blind, randomized, placebo-controlled design. Eligible treatment-naïve patients with Helicobacter pylori (Hp) infection complicated by metabolic-associated steatohepatitis (MASH) (dampness-heat accumulation syndrome) were enrolled and randomly assigned to either the experimental group or… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Helicobacter Pylori Infection, Metabolic-associated Steatohepatitis, High-dose Dual Therapy
- What is being tested?
- Vonoprazan-amoxicillin combined with Huazhi Rougan Granule
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 286 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2025to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65 years;
- Meeting the diagnostic criteria for metabolic-associated steatohepatitis (MASH) and the traditional Chinese medicine syndrome differentiation criteria for dampness-heat accumulation pattern;
- Initial treatment for H. pylori infection (positive 13C- or 14C-urea breath test);
- Signed informed consent form.
Who cannot join
- Individuals with fatty liver caused by chronic heart failure, malnutrition, or pregnancy; those with fatty liver syndrome in encephalopathy, abetalipoproteinemia, or localized fatty liver;
- Patients with severe fatty liver accompanied by ascites, edema, hyponatremia, hypokalemia, or other signs suggestive of cirrhosis; those with hepatitis or cirrhosis caused by viruses, drug toxicity, autoimmune diseases, or other factors;
- Individuals using hepatoprotective, enzyme-lowering, or lipid-lowering medications that may interfere with efficacy evaluation;
- Pregnant or lactating women;
- Patients with severe primary cardiovascular, renal, or other life-threatening diseases;
- Individuals with a history of cancer;
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- Those positive for HCV antibody, HIV antibody, or HBsAg with detectable HBV-DNA levels;
- Individuals with a history of alcohol abuse (≥210 g/week for males or ≥140 g/week for females) or substance abuse;
- Those with known hypersensitivity to any component of the study drug;
- Participation in another clinical trial within 3 months prior to screening;
- Use of Chinese herbal medicines for the treatment of non-alcoholic simple fatty liver within 2 weeks prior to screening;
- Individuals deemed unsuitable for participation by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial of Huazhi Rougan Granule Combined With High-Dose Dual Therapy for Helicobacter Pylori Infection Complicated With Metabolic-associated Steatohepatitis (Dampness-Heat Accumulation Syndrome)
This study employed a double-blind, randomized, placebo-controlled design. Eligible treatment-naïve patients with Helicobacter pylori (Hp) infection complicated by metabolic-associated steatohepatitis (MASH) (dampness-heat accumulation syndrome) were enrolled and randomly assigned to either the experimental group or the placebo control group. Both groups received a 2-week Hp eradication regimen consisting of vonoprazan (20 mg twice daily) and amoxicillin (1000 mg three times daily). The experimental group additionally received active Huazhi Rougan Granule (taken orally three times daily, one sachet each time, with a 6-day medication followed by a 1-day drug holiday per cycle), while the placebo control group received an identical matching placebo on the same schedule. The study aims to evaluate the synergistic therapeutic efficacy of Huazhi Rougan Granule in combination with the vonoprazan-amoxicillin dual therapy.
- Conditions
- Helicobacter Pylori Infection, Metabolic-associated Steatohepatitis, High-dose Dual Therapy, Huazhi Rougan Granule
- Being tested
- Vonoprazan-amoxicillin combined with Huazhi Rougan Granule, Vonoprazan-amoxicillin combined with Huazhi Rougan Granule placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vonoprazan-amoxicillin combined with Huazhi Rougan GranuleDrug
Vonoprazan-amoxicillin dual therapy combined with Huazhi Rougan Granule
Vonoprazan-amoxicillin combined with Huazhi Rougan Granule placeboDrug
Vonoprazan-amoxicillin dual therapy combined with Huazhi Rougan Granule placebo
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Drug: Vonoprazan-amoxicillin combined with Huazhi Rougan Granule |
| Placebo Group | Placebo comparator | Not described Receives: Drug: Vonoprazan-amoxicillin combined with Huazhi Rougan Granule placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Helicobacter pylori eradication rate
Patients must undergo a follow-up 13C-urea breath test (13C-UBT) after treatment completion to determine eradication success. A DOB value < 4‱ is considered indicative of successful eradication. The eradication rate is calculated as follows: (number of successfully eradicated patients in each group / total number of patients in that group) × 100.00%.
Measured: At the end of the 12-week treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start31 Aug 2025 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2027 (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 Nanjing First Hospital, Nanjing Medical UniversityThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159412
- Sponsor's protocol ID
- KY20250819-12
- Status last verified
- Aug 2025
- First submitted
- 29 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- 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 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Trial of Huazhi Rougan Granule Combined With High-Dose Dual Therapy for Helicobacter Pylori Infection Complicated With Metabolic-associated Steatohepatitis (Dampness-Heat Accumulation Syndrome)
- ClinicalTrials.gov ID
- NCT07159412
- Acronym / sponsor ID
- KY20250819-12
- Conditions
- Helicobacter Pylori Infection, Metabolic-associated Steatohepatitis, High-dose Dual Therapy, Huazhi Rougan Granule
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 31 Aug 2025 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 8 Sep 2025 (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 study employed a double-blind, randomized, placebo-controlled design. Eligible treatment-naïve patients with Helicobacter pylori (Hp) infection complicated by metabolic-associated steatohepatitis (MASH) (dampness-heat accumulation syndrome) were enrolled and randomly assigned to either the experimental group or the placebo control group. Both groups received a 2-week Hp eradication regimen consisting of vonoprazan (20 mg twice daily) and amoxicillin (1000 mg three times daily). The experimental group additionally received active Huazhi Rougan Granule (taken orally three times daily, one sachet each time, with a 6-day medication followed by a 1-day drug holiday per cycle), while the placebo control group received an identical matching placebo on the same schedule. The study aims to evaluate the synergistic therapeutic efficacy of Huazhi Rougan Granule in combination with the vonoprazan-amoxicillin dual therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Drug: Vonoprazan-amoxicillin combined with Huazhi Rougan Granule |
| Placebo Group | Placebo comparator | Drug: Vonoprazan-amoxicillin combined with Huazhi Rougan Granule placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18-65 years;
- Meeting the diagnostic criteria for metabolic-associated steatohepatitis (MASH) and the traditional Chinese medicine syndrome differentiation criteria for dampness-heat accumulation pattern;
- Initial treatment for H. pylori infection (positive 13C- or 14C-urea breath test);
- Signed informed consent form.
Key exclusion criteria (12 listed)
- Individuals with fatty liver caused by chronic heart failure, malnutrition, or pregnancy; those with fatty liver syndrome in encephalopathy, abetalipoproteinemia, or localized fatty liver;
- Patients with severe fatty liver accompanied by ascites, edema, hyponatremia, hypokalemia, or other signs suggestive of cirrhosis; those with hepatitis or cirrhosis caused by viruses, drug toxicity, autoimmune diseases, or other factors;
- Individuals using hepatoprotective, enzyme-lowering, or lipid-lowering medications that may interfere with efficacy evaluation;
- Pregnant or lactating women;
- Patients with severe primary cardiovascular, renal, or other life-threatening diseases;
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 |
|---|---|---|
| Vonoprazan-amoxicillin combined with Huazhi Rougan GranuleVonoprazan-amoxicillin dual therapy combined with Huazhi Rougan Granule | Drug | Intervention Group |
| Vonoprazan-amoxicillin combined with Huazhi Rougan Granule placeboVonoprazan-amoxicillin dual therapy combined with Huazhi Rougan Granule placebo | Drug | Placebo Group |
Primary outcome
Helicobacter pylori eradication rate
Time frame: At the end of the 12-week treatment period.
Patients must undergo a follow-up 13C-urea breath test (13C-UBT) after treatment completion to determine eradication success. A DOB value < 4‱ is considered indicative of successful eradication. The eradication rate is calculated as follows: (number of successfully eradicated patients in each group / total number of patients in that group) × 100.00%.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Vonoprazan-amoxicillin combined with Huazhi Rougan Granule in people with Helicobacter Pylori Infection and Metabolic-associated Steatohepatitis, run by Nanjing First Hospital, Nanjing Medical 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 4 inclusion and 12 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: opening soon, as of the sponsor's last update on 8 Sep 2025. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wanli Liu (18951768998, 18951768998@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: At the end of the 12-week treatment period.). 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 8 Sep 2025.