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

NCT02803216 | Completed Phase 1 DMC

• 1 other identifier: Digestion-02
• Study Type: interventional
• Target: 576
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• H. pylori eradication rate

  13C or 14C urea breath test was performed at four weeks after western medicine termination.

Secondary Outcomes (1)

• 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.

Study Arms (3)

standard triple region

EXPERIMENTAL

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

Drug: standard triple region

standard triple region +2-week TCM

ACTIVE COMPARATOR

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

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

standard triple region +4-week TCM

ACTIVE COMPARATOR

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

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

Interventions

standard triple region DRUG

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

Also known as: omeprazole, amoxicillin, clarithromycin

standard triple region; standard triple region +2-week TCM; standard triple region +4-week TCM

2-week Xiang-sha-liu-jun decoction DRUG

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

standard triple region +2-week TCM

4-week Xiang-sha-liu-jun decoction DRUG

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

standard triple region +4-week TCM

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiyuan Hospital of China Academy of Chinese Medical Sciences: lead

MeSH Terms

Interventions

Omeprazole; Amoxicillin; Clarithromycin

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Erythromycin; Macrolides; Polyketides; Lactones

Study Officials

• xudong Tang, Ph.D

  XiYuan Hospital of China Academy of Traditional Chinese Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2016
• First Posted: June 16, 2016
• Study Start: January 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: April 1, 2016
• Last Updated: September 5, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will share