Helicobacter Pylori Infection
Conditions
Brief summary
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.
Interventions
DRUG4-week Xiang-sha-liu-jun decoction
4-week Xiang-sha-liu-jun decoction, bid.
DRUGstandard triple region
ten days of standard triple region (20mg omeprazole 20mg, 1.0 amoxicillin, 0.5 clarithromycin, Bid).
DRUG2-week Xiang-sha-liu-jun decoction
2-week Xiang-sha-liu-jun decoction, bid.
Sponsors
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| H. pylori eradication rate | 13C or 14C urea breath test was performed at four weeks after western medicine termination. |
Secondary
| Measure | 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. |
Outcome results
None listed