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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00508729
Other study ID # 2006BAI04A15-1
Secondary ID
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
Est. primary completion date
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


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
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