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

NCT00508729 | Unknown Phase 2

• 1 other identifier: 2006BAI04A15-1
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Pancreatitis, Acute Necrotizing

Outcome Measures

Primary Outcomes (4)

• Mortality

  endpoint of the trial

• Morbidity

  endpoint of the trial

• Hospitalization days

  endpoint of the trial

• Total expenses

  endpoint of the trial

Secondary Outcomes (2)

• 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

• 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

Interventions

Qingyi granules DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin Nankai Hospital: lead
• Peking Union Medical College: collaborator

Study Sites (10)

Affiliated Hospital of Guangdong Medical College

Zhanjiang, Guangdong, 524001, China

Location

Guizhou Province People's Hospital

Guiyang, Guizhou, 550002, China

Location

The 1st Affiliated Hospital, Dalian Medical Unversity

Dalian, Liaoning, 116011, China

Location

West China Hospital, Sichuan Unversity

Chengdu, Sichuan, 610041, China

Location

Zhejiang Province People's Hospital

Hangzhou, Zhejiang, China

Location

Zhejiang Province Traditional Chinese Medicine Hospital

Hangzhou, Zhejiang, China

Location

Dongzhimen Hospital of Beijing Traditional Chinese Medicine University

Beijing, 100700, China

Location

Peking Union Medical College Hospital

Beijing, 100730, China

Location

Longhua Hospital of Shanghai Traditional Chinese Medicine Unversity

Shanghai, 200032, China

Location

Tianjin Nankai Hospital

Tianjin, 300100, China

Location

MeSH Terms

Conditions

Pancreatitis, Acute Necrotizing

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases

Study Officials

• Naiqiang Cui, Dr

  Tianjin Nankai Hospital

  PRINCIPAL INVESTIGATOR

• Zhuming Jiang, Dr

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naiqiang Cui, Dr

CONTACT

+86 22 27022268; cuinq@sohu.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 26, 2007
• First Posted: July 30, 2007
• Study Start: October 1, 2007
• Study Completion: October 1, 2010
• Last Updated: July 31, 2007

Record last verified: 2007-07

Locations

CN (10)