Effect of Traditional Chinese Medicine on GI Function Recovery and Nutrition Support in SAP

Pancreatitis, Acute Necrotizing Clinical Trial

Official title:

Effect of Traditional Chinese Medicine on Gastrointestinal Function Recovery and Nutrition Support in Severe Acute Pancreatitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00508729
• Other study ID #: 2006BAI04A15-1
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: July 26, 2007
• Last updated: July 29, 2007
• Start date: October 2007
• Est. completion date: October 2010

Study information

• Verified date: July 2007
• Source: Tianjin Nankai Hospital
• Contact: Naiqiang Cui, Dr
• Phone: +86 22 27022268
• Email: cuinq[@]sohu.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical 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. Drawing in latest research fruits at home and abroad, a clinical practical guideline would be formed, to be popularized all over China.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatitis
• Pancreatitis, Acute Necrotizing

Intervention

Drug:
• Qingyi granules

Locations

Country	Name	City	State
China	Dongzhimen Hospital of Beijing Traditional Chinese Medicine University	Beijing
China	Peking Union Medical College Hospital	Beijing
China	West China Hospital, Sichuan Unversity	Chengdu	Sichuan
China	The 1st Affiliated Hospital, Dalian Medical Unversity	Dalian	Liaoning
China	Guizhou Province People's Hospital	Guiyang	Guizhou
China	Zhejiang Province People's Hospital	Hangzhou	Zhejiang
China	Zhejiang Province Traditional Chinese Medicine Hospital	Hangzhou	Zhejiang
China	Longhua Hospital of Shanghai Traditional Chinese Medicine Unversity	Shanghai
China	Tianjin Nankai Hospital	Tianjin
China	Affiliated Hospital of Guangdong Medical College	Zhanjiang	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Tianjin Nankai Hospital	Peking Union Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		endpoint of the trial
Primary	Morbidity		endpoint of the trial
Primary	Hospitalization days		endpoint of the trial
Primary	Total expenses		endpoint of the trial
Secondary	G-I tract function: nature of abdominal pain, intra-abdominal pressure, number of bowel movements		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
Secondary	Parameters of nutrition		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