Pancreatitis, Acute NecrotizingPhase 2/3NCT00506337
Evaluation of Effect of Integrated Treatment by Traditional Chinese and Western Medicine for Severe Acute Pancreatitis
A Phase 2/3 study testing Qingyi granules in people with Pancreatitis, Acute Necrotizing, run by Tianjin Nankai Hospital at 3 sites in China.
Trial summary
With multicenter randomized control clinical evaluation investigations, the scheme of integrated medicine treatment of severe acute pancreatitis (SAP) was further improved, 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
- 3 sitesChina
- Study dates
- Oct 2006to Oct 2009
- 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
- Adult, Older adult
Who may be able to join
- Adult patients 18yr-70yr, 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
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
West China Hospital, Sichuan Unversity
Chengdu, Sichuan, 610041
Qing Xia, Dr, xiaqing@medmail.com.cn
- Recruiting
The 1st Affiliated Hospital, Dalian Medical Unversity
Dalian, Liaoning, 116011
Qinghui Qi, Dr, qiqh@medmail.com.cn
- Recruiting
Tianjin Nankai Hospital
Tianjin, 300100
Naiqiang Cui, Dr, +86 22 27022268 ext. 3892, cuinq@sohu.com
About this study
With multicenter randomized control clinical evaluation investigations, the scheme of integrated medicine treatment of severe acute pancreatitis (SAP) was further improved, and the therapeutic effects, safety and indications assured. Drawing in latest research fruits at home and abroad, a clinical practical guideline for integrated medicine of diagnosis and treatment of SAP 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
Control group: The therapeutic methods accord to the concert schemes cited in the "Guides to diagnosis and treatment of severe acute pancreatitis" introduced by the Pancreatic Surgery Group of Surgical Chapter of Chinese Medical Association.
Treatment group: In addition to the concert schemes cited in the "Guides to diagnosis and treatment of severe acute pancreatitis", during the first stage of the disease herbal Qingyi granules 1-B 4 bags dissolved in water 200ml were administered through the gastric tube q6h. Then the gastric tube was closed for 1h, and Qingyi granules 1-B another 4 bags dissolved in water 400ml were given through enema q6h. During the second stage (from the 2nd week to the 4th week after onset) Qingyi granules 2-B 2bags dissolved in water 200ml were added QD.
What is being measured
The primary outcome is the main question the study is designed to answer.
1,Mortality 2,Morbidity 3,Crossing stage cure rates 4,Number of operation procedures 5,Incidences of secondary infections 6,Hospitalization days 7,Total expenses 8,Traditional Chinese medicine diagnostic parameters
Measured: To observe the relationship between the parameters of the first and second stages and the endpoints
Secondary outcomes (1)
1.Routine laboratory tests, blood and urine amylase, blood lipase. 2.Important visceral function criteria 3.microorganism culture, endotoxin determination, CRP 4.B-ultrasound, CT, chest films, plain abdomen film
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 posted25 Jul 2007 (estimated)
- Study startOct 2006
- Study completionOct 2009 (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
- Sichuan University
- Investigators
- Naiqiang Cui, Dr, Principal investigator, Tianjin Nankai HospitalQing Xia, Dr, Principal investigator, West China HospitalQinghui Qi, Dr, Principal investigator, The 1st Affiliated Hospital, Dalian Medical Unversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00506337
- Sponsor's protocol ID
- 2006BAI04A15
- Status last verified
- Jul 2007
- First submitted
- 23 Jul 2007
- Last updated
- 31 Jul 2007
- Results posted
- No
- Data monitoring committee
- Yes
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
- Evaluation of Effect of Integrated Treatment by Traditional Chinese and Western Medicine for Severe Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT00506337
- Acronym / sponsor ID
- 2006BAI04A15
- 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
- Sichuan University
- Study start
- Oct 2006
- Study completion
- Oct 2009 (estimated)
- First posted
- 25 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 scheme of integrated medicine treatment of severe acute pancreatitis (SAP) was further improved, and the therapeutic effects, safety and indications assured. Drawing in latest research fruits at home and abroad, a clinical practical guideline for integrated medicine of diagnosis and treatment of SAP 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
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients 18yr-70yr, 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 (1 listed)
- 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.
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 granulesControl group: The therapeutic methods accord to the concert schemes cited in the "Guides to diagnosis and treatment of severe acute pancreatitis" introduced by the Pancreatic Surgery Group of Surgical Chapter of Chinese Medical Association. Treatment group: In addition to the concert schemes cited in the "Guides to diagnosis and treatment of severe acute pancreatitis", during the first stage of the disease herbal Qingyi granules 1-B 4 bags dissolved in water 200ml were administered through the gastric tube q6h. Then the gastric tube was closed for 1h, and Qingyi granules 1-B another 4 bags dissolved in water 400ml were given through enema q6h. During the second stage (from the 2nd week to the 4th week after onset) Qingyi granules 2-B 2bags dissolved in water 200ml were added QD. | Drug | – |
Primary outcome
1,Mortality 2,Morbidity 3,Crossing stage cure rates 4,Number of operation procedures 5,Incidences of secondary infections 6,Hospitalization days 7,Total expenses 8,Traditional Chinese medicine diagnostic parameters
Time frame: To observe the relationship between the parameters of the first and second stages and the endpoints
1 secondary outcome
1.Routine laboratory tests, blood and urine amylase, blood lipase. 2.Important visceral function criteria 3.microorganism culture, endotoxin determination, CRP 4.B-ultrasound, CT, chest films, plain abdomen film
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
Qing Xia, Dr principal investigator
West China Hospital
Qinghui Qi, Dr principal investigator
The 1st Affiliated Hospital, Dalian Medical Unversity
3 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 3 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 1 inclusion and 1 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 3 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?
1,Mortality 2,Morbidity 3,Crossing stage cure rates 4,Number of operation procedures 5,Incidences of secondary infections 6,Hospitalization days 7,Total expenses 8,Traditional Chinese medicine diagnostic parameters (time frame: To observe the relationship between the parameters of the first and second stages and the endpoints). 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.