GastritisNCT00920712
Study of the Chinese Prescription Weiqi Decoction on Chronic Atrophic Gastritis
A study testing Weiqi decotion in people with Gastritis, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of the Chinese prescription Weiqi decoction on Chronic Atrophic Gastritis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastritis
- What is being tested?
- Weiqi decotion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Aug 2009to Jul 2012
- Phase
- Interventional
- 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
- Clinical diagnosis of Chronic Atrophic Gastritis
- Male of female patients between 18-65 years old
- Written informed consent
Who cannot join
- Combine with malignant pathology on epithelial dysplasia of gastric mucosa
- Combine with duodenal ulcer or gastric ulcer
- Combined with severe heart, gallbladder, kidney, endocrine system, hemopoietic system or nervous system disease.
- Pregnancy or breast feeding women, or unwilling to have contraception.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the efficacy and safety of the Chinese prescription Weiqi decoction on Chronic Atrophic Gastritis.
- Conditions
- Gastritis
- Being tested
- Weiqi decotion
- Keywords
- chronic atrophic gastritis, Traditional Chinese Medicine
- Medical subject headings
- Gastritis, Gastritis, Atrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weiqi decotionDrug
Decoction ,two times a day
| Study group | Role | What they receive |
|---|---|---|
| Weiqi decoction | Experimental | Not described Receives: Drug: Weiqi decotion |
| low dose of Weiqi decoction | Placebo comparator | Not described Receives: Drug: Weiqi decotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms and conditions of tongue and pulse,the gastroscopy and pathological change
Measured: 12 weeks
Secondary outcomes (1)
Indicates of liver and renal function
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2009 (estimated)
- Study startAug 2009
- Primary completionJun 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastritisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xie Jianqun, Phd, Study director, Shanghai University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00920712
- Sponsor's protocol ID
- SHTCM-001
- Status last verified
- Aug 2009
- First submitted
- 11 Jun 2009
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Chinese Prescription Weiqi Decoction on Chronic Atrophic Gastritis
- ClinicalTrials.gov ID
- NCT00920712
- Acronym / sponsor ID
- SHTCM-001
- Conditions
- Gastritis
- Keywords
- chronic atrophic gastritis, Traditional Chinese Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 15 Jun 2009 (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.
The purpose of this study is to evaluate the efficacy and safety of the Chinese prescription Weiqi decoction on Chronic Atrophic Gastritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weiqi decoction | Experimental | Drug: Weiqi decotion |
| low dose of Weiqi decoction | Placebo comparator | Drug: Weiqi decotion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of Chronic Atrophic Gastritis
- Male of female patients between 18-65 years old
- Written informed consent
Key exclusion criteria (4 listed)
- Combine with malignant pathology on epithelial dysplasia of gastric mucosa
- Combine with duodenal ulcer or gastric ulcer
- Combined with severe heart, gallbladder, kidney, endocrine system, hemopoietic system or nervous system disease.
- Pregnancy or breast feeding women, or unwilling to have contraception.
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 |
|---|---|---|
| Weiqi decotionDecoction ,two times a day | Drug | Weiqi decoction, low dose of Weiqi decoction |
Primary outcome
Symptoms and conditions of tongue and pulse,the gastroscopy and pathological change
Time frame: 12 weeks
1 secondary outcome
Indicates of liver and renal function
Time frame: 12 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 19 Apr 2016.
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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.
Xie Jianqun, Phd study director
Shanghai University of Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weiqi decotion in people with Gastritis, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
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 3 inclusion and 4 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 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Symptoms and conditions of tongue and pulse,the gastroscopy and pathological change (time frame: 12 weeks). 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 19 Apr 2016.