The Clinical Study of Acute Pancreatitis Treated by TongF... | NCT02204189

Studies
The Clinical Study of Acute Pancreatitis Treated by TongFuSan

NCT02204189

Sponsor

Beijing Friendship Hospital

Status

Unknown status

Last Update Posted

Jul 30, 2014Estimated

Enrollment

100Estimated

Phase

Phase 1Phase 2

Conditions

Acute Pancreatitis

Interventions

TongFuSan

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 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Oct 2014Estimated

Completion Date

Feb 2017Estimated

First Submitted Date

Jul 29, 2014

First Submission Date that Met QC Criteria

Jul 29, 2014

First Posted Date

Jul 30, 2014Estimated

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, 2014

Last Update Posted Date

Jul 30, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

miaobin, associate chief physician, Beijing Friendship HospitalPrincipal Investigator

Lead Sponsor

Beijing Friendship HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of this study is to determine whether TongFuSan is effective in the treatment of acute pancreatitis with gastrointestinal dysfunction.

Detailed Description

Patient who is diagnosed with acute pancreatitis(AP) should be included.
Patients will be divided into two groups as random number table: control group(A) and experimental group(B).
Group A will be given Mosapride po,and group B will be given TongFusan except for basic treatments of AP.
Same investigator will write the case report form.
Investigator will collect the patients' blood in three points: on admission, the third day and the seventh day.
Otherwise, we need write down patients' clinical manifestation,Traditional Chinese Medicine differentiation, the result of clinical tests.
When the patient discharge, we will write down the treatment measures, therapeutic effect, length of stay and the costs.

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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TongFuSan	Experimental	TongFuSan 1g per time, change every day, the duration is seven days	Drug: TongFuSan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TongFuSan	Drug	TongFuSan 1g	TongFuSan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the time of first defecation		ten days

Secondary Outcomes

Measure	Description	Time Frame
the time of bowel sounds getting back to normal		ten days

Other Outcomes

Measure	Description	Time Frame
Hospitalization cost		ten days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

clinical diagnosis of acute pancreatitis，both mild type and severe type

Exclusion Criteria:

pregnant or suckling
cancer in late time
patient near death

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hong You, PHD	Contact	010-63139197
Bin Miao, PHD	Contact	18612252085		miaobin0105@126.com

Overall Officials

Name	Affiliation	Role
Bin Miao, PHD	Beijing Friendship Hospital	Study Chair
Hong Wang, Graduate	Beijing Friendship Hospital	Study Director
Shuwen Zhang, bachelor

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Friendship Hospital	Recruiting	Beijing	Beijing Municipality	100054	China

Condition Browse Module

MeSH Terms

ID	Term
D010195	Pancreatitis

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided