Pancreatitis, Acute NecrotizingPhase 2/3NCT00508729
Effect of Traditional Chinese Medicine on GI Function Recovery and Nutrition Support in SAP
A Phase 2/3 study testing Qingyi granules in people with Pancreatitis, Acute Necrotizing, run by Tianjin Nankai Hospital at 10 sites in China.
Trial summary
With multicenter randomized control clinical evaluation investigations, the effect of traditional Chinese medicine on gastrointestinal function recovery and nutrition support in early stage of severe acute pancreatitis (SAP) was evaluated, and the therapeutic effects, safety and indications assured. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pancreatitis, Acute Necrotizing
- What is being tested?
- Qingyi granules
- How many people
- 300 participants
- Where
- 10 sitesChina
- Study dates
- Oct 2007to Oct 2010
- Phase
- Phase 2/3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients 18 yr-70 yr
- Complying with the diagnostic standard of acute pancretitis (clinical symptoms and signs, elevated blood and urine amylase, and imaging criteria)
- Conforming to 3 or more Ranson's criteria and APACHE-II score larger than 8, Balhazar CT score larger than 5
Who cannot join
- Pregnancy
- Nursing mother
- Critical cases of advanced tumor
- On the verge of death (estimated to be moral in 12h)
- Severe visceral function disturbance
- Patients undergoing other therapeutic research that might interfere with the present study
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
Dongzhimen Hospital of Beijing Traditional Chinese Medicine University
Beijing, 100700
Naiqing Li, Dr, 13301119560@m165.com
Peking Union Medical College Hospital
Beijing, 100730
West China Hospital, Sichuan Unversity
Chengdu, Sichuan, 610041
The 1st Affiliated Hospital, Dalian Medical Unversity
Dalian, Liaoning, 116011
Guizhou Province People's Hospital
Guiyang, Guizhou, 550002
Chengxian Shi, Dr, chengxia1@yahoo.com.cn
Zhejiang Province People's Hospital
Hangzhou, Zhejiang
Zaiyuang Ye, Dr, zaiyuanye@163.com
Zhejiang Province Traditional Chinese Medicine Hospital
Hangzhou, Zhejiang
Qin Zhang, Dr, hz166cn@163.com
Longhua Hospital of Shanghai Traditional Chinese Medicine Unversity
Shanghai, 200032
JIngzhe Zhang, Dr, zjzzzq@sina.com
Tianjin Nankai Hospital
Tianjin, 300100
Affiliated Hospital of Guangdong Medical College
Zhanjiang, Guangdong, 524001
Huilai Miao, Dr, miaohuilai@tom.com
About this study
Official title: Effect of Traditional Chinese Medicine on Gastrointestinal Function Recovery and Nutrition Support in Severe Acute Pancreatitis
With multicenter randomized control clinical evaluation investigations, the effect of traditional Chinese medicine on gastrointestinal function recovery and nutrition support in early stage of severe acute pancreatitis (SAP) was evaluated, and the therapeutic effects, safety and indications assured. Drawing in latest research fruits at home and abroad, a clinical practical guideline would be formed, to be popularized all over China.
- Conditions
- Pancreatitis, Acute Necrotizing
- Being tested
- Qingyi granules
- Medical subject headings
- Pancreatitis, Acute Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qingyi granulesDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: endpoint of the trial
Morbidity
Measured: endpoint of the trial
Hospitalization days
Measured: endpoint of the trial
Total expenses
Measured: endpoint of the trial
Secondary outcomes (2)
G-I tract function: nature of abdominal pain, intra-abdominal pressure, number of bowel movements
Measured: The above criteria should be tested on admission, and 24h, 48h and 72h later, 5d, 7d, and 2wks after admission, and on the day of discharge
Parameters of nutrition
Measured: The above criteria should be tested on admission, and 24h, 48h and 72h later, 5d, 7d, and 2wks after admission, and on the day of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2007 (estimated)
- Study startOct 2007
- Study completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatitis, Acute NecrotizingStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Nankai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College
- Investigators
- Naiqiang Cui, Dr, Principal investigator, Tianjin Nankai HospitalZhuming Jiang, Dr, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00508729
- Sponsor's protocol ID
- 2006BAI04A15-1
- Status last verified
- Jul 2007
- First submitted
- 26 Jul 2007
- Last updated
- 31 Jul 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Traditional Chinese Medicine on Gastrointestinal Function Recovery and Nutrition Support in Severe Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT00508729
- Acronym / sponsor ID
- 2006BAI04A15-1
- Conditions
- Pancreatitis, Acute Necrotizing
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Tianjin Nankai HospitalUniversity, hospital or other
- Collaborators
- Peking Union Medical College
- Study start
- Oct 2007
- Study completion
- Oct 2010 (estimated)
- First posted
- 30 Jul 2007 (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.
With multicenter randomized control clinical evaluation investigations, the effect of traditional Chinese medicine on gastrointestinal function recovery and nutrition support in early stage of severe acute pancreatitis (SAP) was evaluated, and the therapeutic effects, safety and indications assured. Drawing in latest research fruits at home and abroad, a clinical practical guideline would be formed, to be popularized all over China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients 18 yr-70 yr
- Complying with the diagnostic standard of acute pancretitis (clinical symptoms and signs, elevated blood and urine amylase, and imaging criteria)
- Conforming to 3 or more Ranson's criteria and APACHE-II score larger than 8, Balhazar CT score larger than 5
Key exclusion criteria (6 listed)
- Pregnancy
- Nursing mother
- Critical cases of advanced tumor
- On the verge of death (estimated to be moral in 12h)
- Severe visceral function disturbance
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 |
|---|---|---|
| Qingyi granules | Drug | – |
Primary outcome
Mortality
Time frame: endpoint of the trial
Morbidity
Time frame: endpoint of the trial
Hospitalization days
Time frame: endpoint of the trial
Total expenses
Time frame: endpoint of the trial
2 secondary outcomes
G-I tract function: nature of abdominal pain, intra-abdominal pressure, number of bowel movements
Time frame: The above criteria should be tested on admission, and 24h, 48h and 72h later, 5d, 7d, and 2wks after admission, and on the day of discharge
Parameters of nutrition
Time frame: The above criteria should be tested on admission, and 24h, 48h and 72h later, 5d, 7d, and 2wks after admission, and on the day of discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2007.
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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.
Naiqiang Cui, Dr principal investigator
Tianjin Nankai Hospital
Zhuming Jiang, Dr principal investigator
Peking Union Medical College Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Qingyi granules in people with Pancreatitis, Acute Necrotizing, run by Tianjin Nankai Hospital at 10 sites 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 6 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: status not confirmed, as of the sponsor's last update on 31 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naiqiang Cui, Dr (+86 22 27022268 ext. 3892, cuinq@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: endpoint of the trial). The study lists 4 primary outcomes in all. 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 31 Jul 2007.