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

Helicobacter Pylori Infection Clinical Trial

Official title:

The Effect and Safety of Jinghua Weikang Capsule Containing Quadruple Therapy for IgAN With Helicobacter Pylori Infection, a Randomized Pilot Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05320133
• Other study ID #: 2021CR36
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 20, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2022
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• IgA nephropathy diagnosed by renal biopsy;

• Current Helicobacter pylori infection;

• Age 18-65.

Exclusion Criteria:

• ?eGFR<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.

Related Conditions & MeSH terms

• Communicable Diseases
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infections

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Helicobacter pylori eradicaion rate	The Helicobacter pylori infection status was measured by 13-carbon breath test.	The forth week after the treatment.
Secondary	Blood creatinine level	The change of average blood creatinine level between two groups.	Baseline, the third and sixth month after the treatment, respectively.
Secondary	Blood urea nitrogen level	The change of average blood urea nitrogen level between two groups.	Baseline, the third and sixth month after the treatment, respectively.
Secondary	eGFR	The change of average eGFR level between two groups.	Baseline, the third and sixth month after the treatment, respectively.
Secondary	24hrs urine protein level	The change of average24hrs urine protein level between two groups.	Baseline, the third and sixth month after the treatment, respectively.
Secondary	Blood presure	The change of average blood presure level between two groups.	Baseline, the third and sixth month after the treatment, respectively.
Secondary	IgA level	The change of average IgA level level between two groups.	Baseline, the third and sixth month after the treatment, respectively.
Secondary	IgA1 level	The change of average IgA1 level between two groups.	Baseline, the third and sixth month after the treatment, respectively.
Secondary	Gd-IgA1 level	The change of average Gd-IgA1 level level between two groups.	Baseline, the third and sixth month after the treatment, respectively.