Effect of Traditional Chinese Medicine on GI Function Rec... | NCT00508729

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

NCT00508729

Sponsor

Tianjin Nankai Hospital

Status

Unknown status

Last Update Posted

Jul 31, 2007Estimated

Enrollment

300Estimated

Phase

Phase 2Phase 3

Conditions

Pancreatitis, Acute Necrotizing

Interventions

Qingyi granules

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Not provided

Completion Date

Oct 2010Estimated

First Submitted Date

Jul 26, 2007

First Submission Date that Met QC Criteria

Jul 27, 2007

First Posted Date

Jul 30, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2007

Last Update Posted Date

Jul 31, 2007Estimated

Name	Class
Peking Union Medical College	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Name	Type	Description	Arm Group Labels	Other Names
Qingyi granules	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality		endpoint of the trial
Morbidity		endpoint of the trial
Hospitalization days		endpoint of the trial
Total expenses		endpoint of the trial

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Naiqiang Cui, Dr	Contact	+86 22 27022268	3892	cuinq@sohu.com

Overall Officials

Name	Affiliation	Role
Naiqiang Cui, Dr	Tianjin Nankai Hospital	Principal Investigator
Zhuming Jiang, Dr	Peking Union Medical College Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Affiliated Hospital of Guangdong Medical College		Zhanjiang	Guangdong	524001	China

Condition Browse Module

MeSH Terms

ID	Term
D019283	Pancreatitis, Acute Necrotizing

Ancestor Terms

ID	Term
D010195	Pancreatitis
D010182	Pancreatic Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided