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

Phase 1

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: standard triple region; Drug: 2-week Xiang-sha-liu-jun decoction; Drug: 4-week Xiang-sha-liu-jun decoction

• Registration Number: NCT02803216
• Lead Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2015-12
• Study Completion: 2016-04
• Study First Submitted: 2016-05-31
• Status Verified: 2016-06
• Study First Submitted QC: 2016-06-13
• Study First Posted: 2016-06-16
• Last Update Submitted: 2016-09-02
• Last Update Posted: 2016-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 576

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard triple region +2-week TCM	2-week Xiang-sha-liu-jun decoction	The patients in this group were given 10 days of standard triple therapy + 2-week Xiang-sha-liu-jun decoction.
standard triple region +4-week TCM	4-week Xiang-sha-liu-jun decoction	The patients in this group were given 10days of standard triple therapy + 4-week Xiang-sha-liu-jun decoction.
standard triple region +2-week TCM	standard triple region	The patients in this group were given 10 days of standard triple therapy + 2-week Xiang-sha-liu-jun decoction.
standard triple region	standard triple region	The patients in this group were given 10-day standard triple therapy.
standard triple region +4-week TCM	standard triple region	The patients in this group were given 10days of standard triple therapy + 4-week Xiang-sha-liu-jun decoction.

Primary Outcome Measures

Name	Time	Method
H. pylori eradication rate	13C or 14C urea breath test was performed at four weeks after western medicine termination.

Secondary Outcome Measures

Name	Time	Method
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.