Helicobacter Pylori InfectionNCT05320133
Jinghua Weikang Capsule Containing Quadruple Therapy for IgAN With Helicobacter Pylori Infection
A study testing JWC containing quadruple therapy and Bismuth-containing quadruple therapy in people with Helicobacter Pylori Infection, run by Peking University First Hospital at 1 site in China.
Trial summary
This study is to evaluate the efficacy and safety of the Jinghua Weikang Capsule (a Chinese patent medicine for peptic ulcer and gastritis) containing quadruple therapy (Jinghua Weikang Caplsule plus triple therpy) for eradicating Helicobacter pylori in IgA nephropathy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- JWC containing quadruple therapy and Bismuth-containing quadruple therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- IgA nephropathy diagnosed by renal biopsy;
- Current Helicobacter pylori infection;
- Age 18-65.
Who cannot join
- ①eGFR<90ml/（min·1.73m2）-
- History of Helicobacter pylori treatment
- Present taking hormones or immunosuppressants
- Malignant tumor and high-grade intraepithelial neoplasia and severe dysplasia of gastric mucosa
- Allergy history to medicines used in the study
- History of gastric surgery
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- Uncontrolled chronic diseases such as diabetes, cardiovascular and cerebrovascular diseases, respiratory diseases, mental disorders and other researchers are considered to affect treatment and assessment
- Combined with other primary or secondary nephropathy except for IgAN
- Combined with acute renal injury
- Female patients with pregnancy, lactation and planned pregnancy.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
Official title: The Effect and Safety of Jinghua Weikang Capsule Containing Quadruple Therapy for IgAN With Helicobacter Pylori Infection, a Randomized Pilot Study
This study is to evaluate the efficacy and safety of the Jinghua Weikang Capsule (a Chinese patent medicine for peptic ulcer and gastritis) containing quadruple therapy (Jinghua Weikang Caplsule plus triple therpy) for eradicating Helicobacter pylori in IgA nephropathy.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- JWC containing quadruple therapy, Bismuth-containing quadruple therapy
- Keywords
- Helicobacter pylori, IgA nephropathy, Jinghua Weikang Caplsule, Bismuth-containing quadruple therapy, Eradication
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JWC containing quadruple therapyDrug
Subjects will receive the rabeprazole 10mg, moxycillin 1.0g, clarithromycin 500mg and Jinghua Weikang Capsule 240mg twice daily for 14 days.
Bismuth-containing quadruple therapyDrug
Subjects will receive the rabeprazole 10mg, moxycillin 1.0g, clarithromycin 500mg and bismuth potassium citrate 220mg twice daily for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| JWC group | Experimental | Jinghua Weikang Capsule containing quadruple therapy. Receives: Drug: JWC containing quadruple therapy |
| Control group | Active comparator | Bismuth-containing quadruple therapy. 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 eradicaion rate
The Helicobacter pylori infection status was measured by 13-carbon breath test.
Measured: The forth week after the treatment.
Secondary outcomes (8)
Blood creatinine level
The change of average blood creatinine level between two groups.
Measured: Baseline, the third and sixth month after the treatment, respectively.
Blood urea nitrogen level
The change of average blood urea nitrogen level between two groups.
Measured: Baseline, the third and sixth month after the treatment, respectively.
eGFR
The change of average eGFR level between two groups.
Measured: Baseline, the third and sixth month after the treatment, respectively.
24hrs urine protein level
The change of average24hrs urine protein level between two groups.
Measured: Baseline, the third and sixth month after the treatment, respectively.
Blood presure
The change of average blood presure level between two groups.
Measured: Baseline, the third and sixth month after the treatment, respectively.
IgA level
The change of average IgA level level between two groups.
Measured: Baseline, the third and sixth month after the treatment, respectively.
IgA1 level
The change of average IgA1 level between two groups.
Measured: Baseline, the third and sixth month after the treatment, respectively.
Gd-IgA1 level
The change of average Gd-IgA1 level level between two groups.
Measured: Baseline, the third and sixth month after the treatment, respectively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start20 Jun 2022
- Primary completion30 Nov 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- HUI YE, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320133
- Sponsor's protocol ID
- 2021CR36
- Status last verified
- Oct 2022
- First submitted
- 30 Mar 2022
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared on https://clinicaltrials.gov.
Publications
Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.
PubMed 38299639
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
- The Effect and Safety of Jinghua Weikang Capsule Containing Quadruple Therapy for IgAN With Helicobacter Pylori Infection, a Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT05320133
- Acronym / sponsor ID
- 2021CR36
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, IgA nephropathy, Jinghua Weikang Caplsule, Bismuth-containing quadruple therapy, Eradication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 11 Apr 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 study is to evaluate the efficacy and safety of the Jinghua Weikang Capsule (a Chinese patent medicine for peptic ulcer and gastritis) containing quadruple therapy (Jinghua Weikang Caplsule plus triple therpy) for eradicating Helicobacter pylori in IgA nephropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JWC group | Experimental | Drug: JWC containing quadruple therapyJinghua Weikang Capsule containing quadruple therapy. |
| Control group | Active comparator | Drug: Bismuth-containing quadruple therapyBismuth-containing quadruple therapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- IgA nephropathy diagnosed by renal biopsy;
- Current Helicobacter pylori infection;
- Age 18-65.
Key exclusion criteria (10 listed)
- ①eGFR<90ml/（min·1.73m2）-
- History of Helicobacter pylori treatment
- Present taking hormones or immunosuppressants
- Malignant tumor and high-grade intraepithelial neoplasia and severe dysplasia of gastric mucosa
- Allergy history to medicines used in the study
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 |
|---|---|---|
| JWC containing quadruple therapySubjects will receive the rabeprazole 10mg, moxycillin 1.0g, clarithromycin 500mg and Jinghua Weikang Capsule 240mg twice daily for 14 days. | Drug | JWC group |
| Bismuth-containing quadruple therapySubjects will receive the rabeprazole 10mg, moxycillin 1.0g, clarithromycin 500mg and bismuth potassium citrate 220mg twice daily for 14 days. | Drug | Control group |
Primary outcome
Helicobacter pylori eradicaion rate
Time frame: The forth week after the treatment.
The Helicobacter pylori infection status was measured by 13-carbon breath test.
8 secondary outcomes
Blood creatinine level
Time frame: Baseline, the third and sixth month after the treatment, respectively.
Blood urea nitrogen level
Time frame: Baseline, the third and sixth month after the treatment, respectively.
eGFR
Time frame: Baseline, the third and sixth month after the treatment, respectively.
24hrs urine protein level
Time frame: Baseline, the third and sixth month after the treatment, respectively.
Blood presure
Time frame: Baseline, the third and sixth month after the treatment, respectively.
IgA level
Time frame: Baseline, the third and sixth month after the treatment, respectively.
IgA1 level
Time frame: Baseline, the third and sixth month after the treatment, respectively.
Gd-IgA1 level
Time frame: Baseline, the third and sixth month after the treatment, respectively.
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.
- Derived from this study: PubMed 38299639Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.
- Individual participant dataSharing planned: Yes. IPD will be shared on https://clinicaltrials.gov.
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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.
HUI YE principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JWC containing quadruple therapy and Bismuth-containing quadruple therapy in people with Helicobacter Pylori Infection, run by Peking University First Hospital at 1 site 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 3 inclusion and 10 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 1 site 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?
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?
Helicobacter pylori eradicaion rate (time frame: The forth week after the treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05320133, which also lists 1 linked publication.
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.