Effects of Jinghuaweikang capsule combined quadruple therapy on the refractory infection of Helicobacter pylori

Not Applicable

Active, not recruiting

• Conditions: Helicobacter pylori; Infections and Infestations; Refractory infection of Helicobacter pylori

• Registration Number: ISRCTN12785009
• Lead Sponsor: China Health Promotion Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-09
• Last Update Posted: 13 September 2021
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 510

Inclusion Criteria

1. Aged 18 to 65 without gender limitation.
2. Meet the refractory Helicobacter pylori infection:
2.1. Referred after three or more than three standard therapy (according to consensus for 10-14 days, at least two times of standard quadruple therapy, at least one time for 14 days) failures in three years.
2.2. Received upper endoscopy and suitable for eradication of Helicobacter pylori.
3. Diagnosed with Helicobacter pylori infection by rapid urease test or 13C-urea breath test results.
4. Proven endoscopic gastritis (including atrophic gastritis and non-atrophic gastritis) or ulcers.
5. Participants without prior penicillin treatment need to demonstrate negative reaction to penicillin skin test.
6. No dyspepsia syndromes of epigastric discomfort, epigastric pain, acid regurgitation, heartburn, and so on, but meet indication of Helicobacter pylori eradication.
7. Accept the medications treatment voluntarily and signed informed consent.

Exclusion Criteria

1. History of stomach operation: partial gastrectomy, stomach plasty, vagotomy (but patients who had simple repair of gastroduodenal ulcer perforation or hemostatic suture of gastroduodenal ulcer were accepted)
2. Pregnancy or lactation, or childbearing age women without reliable contraception (e.g.,oophorectomy, hysterectomy, at least 6 months of tubal ligation, oral contraceptives, barrier method of contraception)
3. Cannot avoid alcohol during the experiment
4 Patients who concomitant with liver disease, kidney disease, cardiovascular disease, brain disease, pulmonary disease, endocrine system diseases, hematopoietic system disease, and other serious primary diseases which is not effectively controlled
5. Severe hepatic and renal insufficiency( transaminase is more than 1.5 times of the normal limit, or serum creatinine more than the upper limit of normal )or liver disease, anemia (hemoglobin < 90 g/L)
6. Allergic to furazolidone, penicillin, rabeprazole or ingredients of JinghuaWeikang Capsule
7. Used antibiotics, bismuth agent (>three timesper week) or clinical trial other drugs within 30 days
8 . Taking anticoagulant therapy or non-steroidal anti-inflammatory drugs (NSAIDs)
9. Swallowing difficulties
10. Used anti-ulcer drugs, including H2-receptor blocking agent, sucralfate, misoprostol or proton pump inhibitor (PPI) within two weeks
11. Zollinger-Ellison syndrome
12. Malignant tumor
13. Included in another clinical trial within 3 months
14. Inappropriate according to the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Elimination rate of Helicobacter pylori is measured using 13C-urea breath test at 56 days

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal symptoms are measured using Scale of gastrointestinal symptoms at baseline, 14 days, 28 days and 56 days