- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00508729
Effect of Traditional Chinese Medicine on GI Function Recovery and Nutrition Support in SAP
July 29, 2007 updated by: Tianjin Nankai Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
300
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Naiqiang Cui, Dr
- Phone Number: 3892 +86 22 27022268
- Email: cuinq@sohu.com
Study Locations
-
-
-
Beijing, China, 100730
- Peking Union Medical College Hospital
-
Beijing, China, 100700
- Dongzhimen Hospital of Beijing Traditional Chinese Medicine University
-
Contact:
- Naiqing Li, Dr
- Email: 13301119560@m165.com
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Shanghai, China, 200032
- Longhua Hospital of Shanghai Traditional Chinese Medicine Unversity
-
Contact:
- JIngzhe Zhang, Dr
- Email: zjzzzq@sina.com
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Tianjin, China, 300100
- Tianjin Nankai Hospital
-
-
Guangdong
-
Zhanjiang, Guangdong, China, 524001
- Affiliated Hospital of Guangdong Medical College
-
Contact:
- Huilai Miao, Dr
- Email: miaohuilai@tom.com
-
-
Guizhou
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Guiyang, Guizhou, China, 550002
- GuiZhou Province People's Hospital
-
Contact:
- Chengxian Shi, Dr
- Email: chengxia1@yahoo.com.cn
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-
Liaoning
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Dalian, Liaoning, China, 116011
- The 1st Affiliated Hospital, Dalian Medical Unversity
-
-
Sichuan
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Chengdu, Sichuan, China, 610041
- West China Hospital, Sichuan Unversity
-
-
Zhejiang
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Hangzhou, Zhejiang, China
- Zhejiang Province People's Hospital
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Contact:
- Zaiyuang Ye, Dr
- Email: zaiyuanye@163.com
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Hangzhou, Zhejiang, China
- Zhejiang Province Traditional Chinese Medicine Hospital
-
Contact:
- Qin Zhang, Dr
- Email: hz166cn@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mortality
Time Frame: endpoint of the trial
|
endpoint of the trial
|
Morbidity
Time Frame: endpoint of the trial
|
endpoint of the trial
|
Hospitalization days
Time Frame: endpoint of the trial
|
endpoint of the trial
|
Total expenses
Time Frame: endpoint of the trial
|
endpoint of the trial
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Naiqiang Cui, Dr, Tianjin Nankai Hospital
- Principal Investigator: Zhuming Jiang, Dr, Peking Union Medical College Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Study Completion (Anticipated)
October 1, 2010
Study Registration Dates
First Submitted
July 26, 2007
First Submitted That Met QC Criteria
July 27, 2007
First Posted (Estimate)
July 30, 2007
Study Record Updates
Last Update Posted (Estimate)
July 31, 2007
Last Update Submitted That Met QC Criteria
July 29, 2007
Last Verified
July 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2006BAI04A15-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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