Helicobacter Pylori Infection Clinical Trial
Official title:
The Clinical Trial on the Eradication of Helicobacter Pylori With Bismuth Agent Quadruple and Modified Ban Xia Xie Xin Decoction
This study is a prospective randomized case-control study. Six hundred patients who were firstly diagnosed as Helicobacter pylori infection will be selected, and then randomly assigned into case group and control group. Patients in control group take bismuth quadruplicate for 14 days. Patients in case group take Ban xia xie xin Decoction and bismuth agent quadruple for 14 days. Exhalation test or stool Helicobacter pylori antigen detection were used to assess the eradication rate of Helicobacter pylori 30 days (the 45th day) after treatment; Adverse reactions were evaluated on the first day (15th day) and the 30th day (45th day) after treatment. The eradication rate of Helicobacter pylori and the adverse drug reactions during the medication will be evaluated. The effect of Ban xia xie xin Decoction and bismuth quadruple based on furazolidone on the eradication of helicobacter pylori infection will be explored.
Helicobacter pylori is a primary carcinogen of gastric cancer. Helicobacter pylori infection rate is about 50% in China. Helicobacter pylori infection should be eradicated unless there are countervailing factors. The bismuth agent quadruple (PPI+bismuth pectin+2 kinds of antibiotics) has eradicated the first line therapy of H. Pylori infection. The rise of antibiotic resistance rate leads to the decline of eradication rate of H. pylori. Traditional Chinese medicine played an important role in the treatment of H. pylori infection. This study explored the application of Ban xia xie xin Decoction and bismuth agent quadruple based on furazolidone in the role of the eradication of H. Pylori infection. This study is a prospective randomized case-control study. Six hundred patients who were firstly diagnosed as Helicobacter pylori infection will be selected, and then randomly assigned into case group and control group. The case group was named as Traditional Chinese Medicine group. Patients in the case group will take Ban xia xie xin Decoction and bismuth quadruplicate for 14 days. The control group was named as bismuth quadruplicate group. Patients in the control group will take bismuth quadruplicate for 14 days. Bismuth quadruplicate includes esomeprazole (nexium 20mg bid), amoxicillin (amoxicillin 1.0 bid), furazolidone (100mg bid) and pectin bismuth gel (150mg qid). Ban xia xie xin Decoction includes 10g of banxia, 10g of huangqin, 6g of coptis chinensis, 6g of dried ginger, 6g of ginseng, 6g of roasted licorice, 6g of Chinese jujube. One dose in the morning and one dose in the evening, and take after meals. Exhalation test or stool Helicobacter pylori antigen detection were used to assess the eradication rate of Helicobacter pylori 30 days (the 45th day) after treatment; Adverse reactions were evaluated on the first day (15th day) and the 30th day (45th day) after treatment. The eradication rate of Helicobacter pylori and the adverse drug reactions during the medication will be evaluated. The effect of Ban xia xie xin Decoction and bismuth quadruple on the eradication of helicobacter pylori infection will be explored. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05061732 -
Helicobacter Pylori Eradication and Follow-up
|
Phase 4 | |
| Completed |
NCT03779074 -
Comparing the Efficacy of Hybrid, High-dose Dual and Bismuth Quadruple Therapies
|
Phase 3 | |
| Completed |
NCT06076681 -
A Study to Evaluate Preliminary Helicobacter Pylori Eradication After Multiple Doses of TNP-2198 Capsules Combined With Rabeprazole Sodium Enteric-coated Tablets, or Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05329636 -
Auto Fecal Microbial Transplant Post Helicobacter Pylori Antibiotic Therapy
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05065138 -
Comparison of Helicobacter Pylori Eradication Effect Before and After Training of Gastroenterologists
|
N/A | |
| Completed |
NCT05049902 -
Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication
|
Phase 4 | |
| Not yet recruiting |
NCT06200779 -
Tailored vs. Empirical Helicobacter Pylori Infection Treatment
|
Phase 4 | |
| Not yet recruiting |
NCT06037122 -
Efficacy of Low-dose Vonoprazan for Helicobacter Pylori Eradication
|
||
| Completed |
NCT04617613 -
Comparing Different Regimens for Eradication of Helicobacter Pylori in Kuwait
|
Phase 4 | |
| Withdrawn |
NCT02552641 -
Food Effect on the Eradication Rate of H. Pylori With Triple Therapy With Esomeprazole
|
Phase 4 | |
| Completed |
NCT02873247 -
Standardize Communication With General Practitioner & Patient for Improved Eradication of Helicobacter Pylori
|
||
| Completed |
NCT02557932 -
Comparison of 7-day PPI-based Standard Triple Therapy and 10-day Bismuth Quadruple Therapy for H. Pylori Eradication
|
Phase 3 | |
| Recruiting |
NCT02249546 -
Efficacy of Acetylcysteine-containing Triple Therapy in the First Line of Helicobacter Pylori Infection
|
Phase 4 | |
| Completed |
NCT01933659 -
Anti-H. Pylori Effect of Deep See Water
|
Phase 3 | |
| Unknown status |
NCT01464060 -
14-day Quadruple Hybrid vs. Concomitant Therapies for Helicobacter Pylori Eradication
|
Phase 4 | |
| Completed |
NCT00841490 -
Oral H. Pylori Prevalence in Intellectually & Developmentally Disabled Adults
|
N/A | |
| Recruiting |
NCT05549115 -
Susceptibility-Guided Sequential Therapy for Helicobacter Pylori Infection
|
N/A | |
| Recruiting |
NCT05728424 -
One vs Two Weeks Treatment for H.Pylori Eradication A RANDOMIZED NON-INFERIORITY PLACEBO CONTROLLED TRIAL
|
Phase 3 | |
| Recruiting |
NCT05997433 -
Efficacy of 7-day Versus 14-day Bismuth Quadruple Therapy for the Eradication of Helicobacter Pylori（SHARE2302)
|
N/A | |
| Completed |
NCT04708405 -
The Relationship Between Helicobacter Pylori Infection and Inflammatory Bowel Diseases: A Real-life Observation
|