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Completed

NCT Number: NCT02803216

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

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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Key information

Conditions

Helicobacter Pylori Infection

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

standard triple region

Drug

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

Other names: omeprazole, amoxicillin, clarithromycin

2-week Xiang-sha-liu-jun decoction

Drug

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

4-week Xiang-sha-liu-jun decoction

Drug

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

Primary outcomes

  1. H. pylori eradication rate

    Time frame: 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

    Time frame: at baseline, and every week up to four weeks.

Sponsors and collaborators

Lead sponsor

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Jun 16, 2016
Registry last updated
Sep 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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