Back to resultsThe Clinical Study of Acute Pancreatitis Treated by TongFuSan
Primary Purpose
Acute Pancreatitis
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
TongFuSan
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pancreatitis focused on measuring acute pancreatitis, gastrointestinal dysfunction, TongFuSan, ShenQue acupoint
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
Sites / Locations
- Beijing Friendship HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TongFuSan
Arm Description
TongFuSan 1g per time, change every day, the duration is seven days
Outcomes
Primary Outcome Measures
the time of first defecation
Secondary Outcome Measures
the time of bowel sounds getting back to normal
Full Information
NCT ID
NCT02204189
First Posted
July 29, 2014
Last Updated
July 29, 2014
Sponsor
Beijing Friendship Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02204189
Brief Title
The Clinical Study of Acute Pancreatitis Treated by TongFuSan
Official Title
The Clinical Study of Acute Pancreatitis With Gastrointestinal Dysfunction Treated by TongFuSan for External Application on ShenQue Acupoint
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
October 2014 (Anticipated)
Study Completion Date
February 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Friendship Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis
Keywords
acute pancreatitis, gastrointestinal dysfunction, TongFuSan, ShenQue acupoint
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TongFuSan
Arm Type
Experimental
Arm Description
TongFuSan 1g per time, change every day, the duration is seven days
Intervention Type
Drug
Intervention Name(s)
TongFuSan
Intervention Description
TongFuSan 1g
Primary Outcome Measure Information:
Title
the time of first defecation
Time Frame
ten days
Secondary Outcome Measure Information:
Title
the time of bowel sounds getting back to normal
Time Frame
ten days
Other Pre-specified Outcome Measures:
Title
Hospitalization cost
Time Frame
ten days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hong You, PHD
Phone
010-63139197
First Name & Middle Initial & Last Name or Official Title & Degree
Bin Miao, PHD
Phone
18612252085
Email
miaobin0105@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bin Miao, PHD
Organizational Affiliation
Beijing Friendship Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hong Wang, Graduate
Organizational Affiliation
Beijing Friendship Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Shuwen Zhang, bachelor
Organizational Affiliation
Beijing Friendship Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Chao Wang, PHD
Organizational Affiliation
Beijing Friendship Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yanli Su, PHD
Organizational Affiliation
Beijing Friendship Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shirong Li, graduate
Organizational Affiliation
Beijing Friendship Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fengwu Li, graduate
Organizational Affiliation
Beijing Friendship Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dinghua Xu, graduate
Organizational Affiliation
Beijing Friendship Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100054
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong You, PHD
Phone
010-63139197
First Name & Middle Initial & Last Name & Degree
Wanzhen Xu, PHD
Phone
010-63138049
First Name & Middle Initial & Last Name & Degree
Fengwu Li, graduate
12. IPD Sharing Statement
Learn more about this trial
The Clinical Study of Acute Pancreatitis Treated by TongFuSan
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