Traditional Chinese Medicine Combined With Standard Triple Region for Eradication of Helicobacter Pylori

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of Traditional Chinese Medicine (TCM) decoction and powder combined with standard triple therapy on improving eradication rate of Helicobacter Pylori (H. pylori).A multi-center randomized control clinical trial design was adopted in the trial.

Official Title
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Traditional Chinese Medicine Combined With Standard Triple Region for Eradication of Helicobacter Pylori: a Prospective, Double-blinded, Randomized Trial

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: standard triple region
* Drug: 2-week Xiang-sha-liu-jun decoction
* Drug: 4-week Xiang-sha-liu-jun decoction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: those who met chronic gastritis (chronic superficial gastritis and chronic atrophic gastritis) diagnostic criteria; aged between 18-65 years old; positive H. pylori infection confirmed by two or more methods of different principles (stop using PPI, H2RA, bismuth, and antibiotics since two weeks before examination); patients were informed consent and willing to accept corresponding treatments. Exclusion criteria: Patients having chronic atrophic gastritis with severe dysplasia, upper gastrointestinal bleeding, peptic ulcers, and gastrointestinal tumors; digestive organic disease (such as chronic pancreatitis, cirrhosis, etc.), or systemic diseases affecting intestinal motility (such as hyperthyroidism, diabetes mellitus, chronic renal insufficiency, mental, and neurological diseases, etc.); those who were accompanied by serious heart, liver and other major organs lesions, blood diseases, and cancer (ALT, AST two times higher than normal value); those who had taken medicines that might affect H. pylori detection results within two weeks (antacids, H2RA, PPIs, bismuth and antibiotics, etc.); pregnant and lactating women; patients with history of systematic and neuropsychiatric disorders; those who had history of any drug allergy; and those who were participating in other clinical trials.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: standard triple region<br>The patients in this group were given 10-day standard triple therapy. | Drug: standard triple region<br>* ten days of standard triple region (20mg omeprazole 20mg, 1.0 amoxicillin, 0.5 clarithromycin, Bid).<br>* Other names: omeprazole, amoxicillin, clarithromycin;|
| Active Comparator: standard triple region +2-week TCM<br>The patients in this group were given 10 days of standard triple therapy + 2-week Xiang-sha-liu-jun decoction. | Drug: standard triple region<br>* ten days of standard triple region (20mg omeprazole 20mg, 1.0 amoxicillin, 0.5 clarithromycin, Bid).<br>* Other names: omeprazole, amoxicillin, clarithromycin;Drug: 2-week Xiang-sha-liu-jun decoction<br>* 2-week Xiang-sha-liu-jun decoction, bid.<br>|
| Active Comparator: standard triple region +4-week TCM<br>The patients in this group were given 10days of standard triple therapy + 4-week Xiang-sha-liu-jun decoction. | Drug: standard triple region<br>* ten days of standard triple region (20mg omeprazole 20mg, 1.0 amoxicillin, 0.5 clarithromycin, Bid).<br>* Other names: omeprazole, amoxicillin, clarithromycin;Drug: 4-week Xiang-sha-liu-jun decoction<br>* 4-week Xiang-sha-liu-jun decoction, bid.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| H. pylori eradication rate |  | 13C or 14C urea breath test was performed at four weeks after western medicine termination. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment |  | at baseline, and every week up to four weeks. |