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

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02803216
• Other study ID #: Digestion-02
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 31, 2016
• Last updated: September 2, 2016
• Start date: January 2013
• Est. completion date: April 2016

Study information

• Verified date: June 2016
• Source: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 576
• Est. completion date: April 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection

Intervention

Drug:
• standard triple region
ten days of standard triple region (20mg omeprazole 20mg, 1.0 amoxicillin, 0.5 clarithromycin, Bid).
• 2-week Xiang-sha-liu-jun decoction
2-week Xiang-sha-liu-jun decoction, bid.
• 4-week Xiang-sha-liu-jun decoction
4-week Xiang-sha-liu-jun decoction, bid.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xiyuan Hospital of China Academy of Chinese Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	H. pylori eradication rate		13C or 14C urea breath test was performed at four weeks after western medicine termination.	Yes
Secondary	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.	Yes