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

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Status and phase: Completed; Phase 2; Phase 1

Conditions: Helicobacter Pylori Infection

Treatments: Drug: 2-week Xiang-sha-liu-jun decoction; Drug: 4-week Xiang-sha-liu-jun decoction; Drug: standard triple region

Study type: Interventional

Funder types: Other

Identifiers

NCT02803216

Digestion-02

Details and patient eligibility

About

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.

Enrollment: 576 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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576 participants in 3 patient groups

standard triple region

Experimental group

Description:

The patients in this group were given 10-day standard triple therapy.

Treatment:

Drug: standard triple region

standard triple region +2-week TCM

Active Comparator group

Description:

The patients in this group were given 10 days of standard triple therapy + 2-week Xiang-sha-liu-jun decoction.

Treatment:

Drug: 2-week Xiang-sha-liu-jun decoction

Drug: standard triple region

standard triple region +4-week TCM

Active Comparator group

Description:

The patients in this group were given 10days of standard triple therapy + 4-week Xiang-sha-liu-jun decoction.

Treatment:

Drug: standard triple region

Drug: 4-week Xiang-sha-liu-jun decoction