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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

576 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-04-30

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.

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Detailed Description

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Conditions

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Helicobacter Pylori Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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standard triple region

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

Group Type EXPERIMENTAL

standard triple region

Intervention Type DRUG

ten days of standard triple region (20mg omeprazole 20mg, 1.0 amoxicillin, 0.5 clarithromycin, Bid).

standard triple region +2-week TCM

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

Group Type ACTIVE_COMPARATOR

standard triple region

Intervention Type DRUG

ten days of standard triple region (20mg omeprazole 20mg, 1.0 amoxicillin, 0.5 clarithromycin, Bid).

2-week Xiang-sha-liu-jun decoction

Intervention Type DRUG

2-week Xiang-sha-liu-jun decoction, bid.

standard triple region +4-week TCM

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

Group Type ACTIVE_COMPARATOR

standard triple region

Intervention Type DRUG

ten days of standard triple region (20mg omeprazole 20mg, 1.0 amoxicillin, 0.5 clarithromycin, Bid).

4-week Xiang-sha-liu-jun decoction

Intervention Type DRUG

4-week Xiang-sha-liu-jun decoction, bid.

Interventions

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standard triple region

ten days of standard triple region (20mg omeprazole 20mg, 1.0 amoxicillin, 0.5 clarithromycin, Bid).

Intervention Type DRUG

2-week Xiang-sha-liu-jun decoction

2-week Xiang-sha-liu-jun decoction, bid.

Intervention Type DRUG

4-week Xiang-sha-liu-jun decoction

4-week Xiang-sha-liu-jun decoction, bid.

Intervention Type DRUG

Other Intervention Names

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omeprazole, amoxicillin, clarithromycin

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No