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

Primary Purpose

Helicobacter Pylori Infection

Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
JWC containing quadruple therapy
Bismuth-containing quadruple therapy
Sponsored by
Peking University First Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring Helicobacter pylori, IgA nephropathy, Jinghua Weikang Caplsule, Bismuth-containing quadruple therapy, Eradication

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking University First Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

JWC group

Control group

Arm Description

Jinghua Weikang Capsule containing quadruple therapy.

Bismuth-containing quadruple therapy.

Outcomes

Primary Outcome Measures

Helicobacter pylori eradicaion rate
The Helicobacter pylori infection status was measured by 13-carbon breath test.

Secondary Outcome Measures

Blood creatinine level
The change of average blood creatinine level between two groups.
Blood urea nitrogen level
The change of average blood urea nitrogen level between two groups.
eGFR
The change of average eGFR level between two groups.
24hrs urine protein level
The change of average24hrs urine protein level between two groups.
Blood presure
The change of average blood presure level between two groups.
IgA level
The change of average IgA level level between two groups.
IgA1 level
The change of average IgA1 level between two groups.
Gd-IgA1 level
The change of average Gd-IgA1 level level between two groups.

Full Information

First Posted
March 30, 2022
Last Updated
October 17, 2022
Sponsor
Peking University First Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05320133
Brief Title
Jinghua Weikang Capsule Containing Quadruple Therapy for IgAN With Helicobacter Pylori Infection
Official Title
The Effect and Safety of Jinghua Weikang Capsule Containing Quadruple Therapy for IgAN With Helicobacter Pylori Infection, a Randomized Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 20, 2022 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University First Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection
Keywords
Helicobacter pylori, IgA nephropathy, Jinghua Weikang Caplsule, Bismuth-containing quadruple therapy, Eradication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
JWC group
Arm Type
Experimental
Arm Description
Jinghua Weikang Capsule containing quadruple therapy.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Bismuth-containing quadruple therapy.
Intervention Type
Drug
Intervention Name(s)
JWC containing quadruple therapy
Intervention Description
Subjects will receive the rabeprazole 10mg, moxycillin 1.0g, clarithromycin 500mg and Jinghua Weikang Capsule 240mg twice daily for 14 days.
Intervention Type
Drug
Intervention Name(s)
Bismuth-containing quadruple therapy
Intervention Description
Subjects will receive the rabeprazole 10mg, moxycillin 1.0g, clarithromycin 500mg and bismuth potassium citrate 220mg twice daily for 14 days.
Primary Outcome Measure Information:
Title
Helicobacter pylori eradicaion rate
Description
The Helicobacter pylori infection status was measured by 13-carbon breath test.
Time Frame
The forth week after the treatment.
Secondary Outcome Measure Information:
Title
Blood creatinine level
Description
The change of average blood creatinine level between two groups.
Time Frame
Baseline, the third and sixth month after the treatment, respectively.
Title
Blood urea nitrogen level
Description
The change of average blood urea nitrogen level between two groups.
Time Frame
Baseline, the third and sixth month after the treatment, respectively.
Title
eGFR
Description
The change of average eGFR level between two groups.
Time Frame
Baseline, the third and sixth month after the treatment, respectively.
Title
24hrs urine protein level
Description
The change of average24hrs urine protein level between two groups.
Time Frame
Baseline, the third and sixth month after the treatment, respectively.
Title
Blood presure
Description
The change of average blood presure level between two groups.
Time Frame
Baseline, the third and sixth month after the treatment, respectively.
Title
IgA level
Description
The change of average IgA level level between two groups.
Time Frame
Baseline, the third and sixth month after the treatment, respectively.
Title
IgA1 level
Description
The change of average IgA1 level between two groups.
Time Frame
Baseline, the third and sixth month after the treatment, respectively.
Title
Gd-IgA1 level
Description
The change of average Gd-IgA1 level level between two groups.
Time Frame
Baseline, the third and sixth month after the treatment, respectively.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HUI YE
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD will be shared on https://clinicaltrials.gov.
IPD Sharing Time Frame
The data will be uploaded within 6 month after Dec 31, 2024.
IPD Sharing Access Criteria
The user of ClinicalTrials.gov PRS could access the data.

Learn more about this trial

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

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