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

Not Applicable

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Bismuth-containing quadruple therapy; Drug: JWC containing quadruple therapy

• Registration Number: NCT05320133
• Lead Sponsor: Peking University First Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-30
• Study First Submitted QC: 2022-04-08
• Study First Posted: 2022-04-11
• Study Start: 2022-06-20
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-17
• Last Update Posted: 2022-10-18
• Primary Completion: 2024-11-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Bismuth-containing quadruple therapy	Bismuth-containing quadruple therapy.
JWC group	JWC containing quadruple therapy	Jinghua Weikang Capsule containing quadruple therapy.

Primary Outcome Measures

Name	Time	Method
Helicobacter pylori eradicaion rate	The forth week after the treatment.	The Helicobacter pylori infection status was measured by 13-carbon breath test.

Secondary Outcome Measures

Name	Time	Method
eGFR	Baseline, the third and sixth month after the treatment, respectively.	The change of average eGFR level between two groups.
Blood creatinine level	Baseline, the third and sixth month after the treatment, respectively.	The change of average blood creatinine level between two groups.
Blood urea nitrogen level	Baseline, the third and sixth month after the treatment, respectively.	The change of average blood urea nitrogen level between two groups.
24hrs urine protein level	Baseline, the third and sixth month after the treatment, respectively.	The change of average24hrs urine protein level between two groups.
Blood presure	Baseline, the third and sixth month after the treatment, respectively.	The change of average blood presure level between two groups.
IgA level	Baseline, the third and sixth month after the treatment, respectively.	The change of average IgA level level between two groups.
IgA1 level	Baseline, the third and sixth month after the treatment, respectively.	The change of average IgA1 level between two groups.
Gd-IgA1 level	Baseline, the third and sixth month after the treatment, respectively.	The change of average Gd-IgA1 level level between two groups.

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China