Helicobacter Pylori InfectionPhase 1/2NCT02803216
Traditional Chinese Medicine Combined With Standard Triple Region for Eradication of Helicobacter Pylori
A Phase 1/2 study testing standard triple region, 2-week Xiang-sha-liu-jun decoction and 4-week Xiang-sha-liu-jun decoction in people with Helicobacter Pylori Infection, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- standard triple region, 2-week Xiang-sha-liu-jun decoction and 4-week Xiang-sha-liu-jun decoction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 576 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Apr 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- standard triple region, 2-week Xiang-sha-liu-jun decoction, 4-week Xiang-sha-liu-jun decoction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard triple regionDrug
Also called omeprazole, amoxicillin, clarithromycin
ten days of standard triple region (20mg omeprazole 20mg, 1.0 amoxicillin, 0.5 clarithromycin, Bid).
2-week Xiang-sha-liu-jun decoctionDrug
2-week Xiang-sha-liu-jun decoction, bid.
4-week Xiang-sha-liu-jun decoctionDrug
4-week Xiang-sha-liu-jun decoction, bid.
| Study group | Role | What they receive |
|---|---|---|
| standard triple region | Experimental | The patients in this group were given 10-day standard triple therapy. Receives: 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. Receives: 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. Receives: Drug: standard triple region; Drug: 4-week Xiang-sha-liu-jun decoction |
What is being measured
The primary outcome is the main question the study is designed to answer.
H. pylori eradication rate
Measured: 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
Measured: at baseline, and every week up to four weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startJan 2013
- Primary completionDec 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 576 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- xudong Tang, Ph.D, Study chair, XiYuan Hospital of China Academy of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02803216
- Sponsor's protocol ID
- Digestion-02
- Status last verified
- Jun 2016
- First submitted
- 31 May 2016
- Last updated
- 5 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional Chinese Medicine Combined With Standard Triple Region for Eradication of Helicobacter Pylori: a Prospective, Double-blinded, Randomized Trial
- ClinicalTrials.gov ID
- NCT02803216
- Acronym / sponsor ID
- Digestion-02
- Conditions
- Helicobacter Pylori Infection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 576 participants (actual)
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 16 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| standard triple region | Experimental | Drug: standard triple regionThe patients in this group were given 10-day standard triple therapy. |
| standard triple region +2-week TCM | Active comparator | Drug: standard triple region, Drug: 2-week Xiang-sha-liu-jun decoctionThe 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 | Active comparator | Drug: standard triple region, Drug: 4-week Xiang-sha-liu-jun decoctionThe patients in this group were given 10days of standard triple therapy + 4-week Xiang-sha-liu-jun decoction. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard triple regionAlso: omeprazole, amoxicillin, clarithromycinten days of standard triple region (20mg omeprazole 20mg, 1.0 amoxicillin, 0.5 clarithromycin, Bid). | Drug | standard triple region, standard triple region +2-week TCM, standard triple region +4-week TCM |
| 2-week Xiang-sha-liu-jun decoction2-week Xiang-sha-liu-jun decoction, bid. | Drug | standard triple region +2-week TCM |
| 4-week Xiang-sha-liu-jun decoction4-week Xiang-sha-liu-jun decoction, bid. | Drug | standard triple region +4-week TCM |
Primary outcome
H. pylori eradication rate
Time frame: 13C or 14C urea breath test was performed at four weeks after western medicine termination.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2016.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
xudong Tang, Ph.D study chair
XiYuan Hospital of China Academy of Traditional Chinese Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing standard triple region, 2-week Xiang-sha-liu-jun decoction and 4-week Xiang-sha-liu-jun decoction in people with Helicobacter Pylori Infection, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
H. pylori eradication rate (time frame: 13C or 14C urea breath test was performed at four weeks after western medicine termination.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2016.