Jinghua Weikang Capsule Containing Quadruple Therapy for IgAN With Helicobacter Pylori Infection

NCT ID: NCT05320133

Last Updated: 2022-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-20

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Helicobacter Pylori Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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JWC group

Jinghua Weikang Capsule containing quadruple therapy.

Group Type EXPERIMENTAL

JWC containing quadruple therapy

Intervention Type DRUG

Subjects will receive the rabeprazole 10mg, moxycillin 1.0g, clarithromycin 500mg and Jinghua Weikang Capsule 240mg twice daily for 14 days.

Control group

Bismuth-containing quadruple therapy.

Group Type ACTIVE_COMPARATOR

Bismuth-containing quadruple therapy

Intervention Type DRUG

Subjects will receive the rabeprazole 10mg, moxycillin 1.0g, clarithromycin 500mg and bismuth potassium citrate 220mg twice daily for 14 days.

Interventions

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JWC containing quadruple therapy

Subjects will receive the rabeprazole 10mg, moxycillin 1.0g, clarithromycin 500mg and Jinghua Weikang Capsule 240mg twice daily for 14 days.

Intervention Type DRUG

Bismuth-containing quadruple therapy

Subjects will receive the rabeprazole 10mg, moxycillin 1.0g, clarithromycin 500mg and bismuth potassium citrate 220mg twice daily for 14 days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* IgA nephropathy diagnosed by renal biopsy;
* Current Helicobacter pylori infection;
* Age 18-65.

Exclusion Criteria

* 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
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University First Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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HUI YE

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

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Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 38299639 (View on PubMed)

Other Identifiers

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2021CR36

Identifier Type: -

Identifier Source: org_study_id

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