Evaluation of Effect of Integrated Treatment by Traditional Chinese and Western Medicine for Severe Acute Pancreatitis
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatitis, Acute Necrotizing |
Drug: Qingyi granules |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Evaluation of Effect of Integrated Treatment by Traditional Chinese and Western Medicine for Severe Acute Pancreatitis |
- 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.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. ]
| Estimated Enrollment: | 300 |
| Study Start Date: | October 2006 |
| Estimated Study Completion Date: | October 2009 |
-
Drug: Qingyi granules
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
Inclusion Criteria:
- 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.
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.
Contacts and Locations| Contact: Naiqiang Cui, Dr | +86 22 27022268 ext 3892 | cuinq@sohu.com |
| China, Liaoning | |
| The 1st Affiliated Hospital, Dalian Medical Unversity | Recruiting |
| Dalian, Liaoning, China, 116011 | |
| Contact: Qinghui Qi, Dr qiqh@medmail.com.cn | |
| China, Sichuan | |
| West China Hospital, Sichuan Unversity | Recruiting |
| Chengdu, Sichuan, China, 610041 | |
| Contact: Qing Xia, Dr xiaqing@medmail.com.cn | |
| China | |
| Tianjin Nankai Hospital | Recruiting |
| Tianjin, China, 300100 | |
| Contact: Naiqiang Cui, Dr +86 22 27022268 ext 3892 cuinq@sohu.com | |
| Principal Investigator: | Naiqiang Cui, Dr | Tianjin Nankai Hospital |
| Principal Investigator: | Qing Xia, Dr | West China Hospital |
| Principal Investigator: | Qinghui Qi, Dr | The 1st Affiliated Hospital, Dalian Medical Unversity |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00506337 History of Changes |
| Other Study ID Numbers: | 2006BAI04A15 |
| Study First Received: | July 23, 2007 |
| Last Updated: | July 29, 2007 |
| Health Authority: | China: Ministry of Health |
Additional relevant MeSH terms:
|
Pancreatitis Pancreatitis, Acute Necrotizing Pancreatic Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013