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

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

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.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: standard triple region; Drug: 2-week Xiang-sha-liu-jun decoction; Drug: 4-week Xiang-sha-liu-jun decoction

• Study Type: Interventional
• Enrollment (Actual): 576
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Investigators: Study Chair: xudong Tang, Ph.D, XiYuan Hospital of China Academy of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: May 31, 2016
• First Submitted That Met QC Criteria: June 13, 2016
• First Posted (Estimate): June 16, 2016

Study Record Updates

• Last Update Posted (Estimate): September 5, 2016
• Last Update Submitted That Met QC Criteria: September 2, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Anti-Ulcer Agents; Proton Pump Inhibitors; Amoxicillin; Clarithromycin; Omeprazole
• Other Study ID Numbers: Digestion-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes