The Clinical Study of Acute Pancreatitis Treated by TongFuSan

July 29, 2014 updated by: miaobin, Beijing Friendship Hospital

The Clinical Study of Acute Pancreatitis With Gastrointestinal Dysfunction Treated by TongFuSan for External Application on ShenQue Acupoint

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100054
        • Recruiting
        • Beijing Friendship Hospital
        • Contact:
          • Hong You, PHD
          • Phone Number: 010-63139197
        • Contact:
          • Wanzhen Xu, PHD
          • Phone Number: 010-63138049
        • Principal Investigator:
          • Fengwu Li, graduate

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TongFuSan
TongFuSan 1g per time, change every day, the duration is seven days
Drug: TongFuSan
TongFuSan 1g

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the time of first defecation
Time Frame: ten days
ten days

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Hospitalization cost
Time Frame: ten days
ten days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Friendship Hospital

Investigators

  • Study Chair: Bin Miao, PHD, Beijing Friendship Hospital
  • Study Director: Hong Wang, Graduate, Beijing Friendship Hospital
  • Study Director: Shuwen Zhang, bachelor, Beijing Friendship Hospital
  • Principal Investigator: Chao Wang, PHD, Beijing Friendship Hospital
  • Principal Investigator: Yanli Su, PHD, Beijing Friendship Hospital
  • Principal Investigator: Shirong Li, graduate, Beijing Friendship Hospital
  • Principal Investigator: Fengwu Li, graduate, Beijing Friendship Hospital
  • Principal Investigator: Dinghua Xu, graduate, Beijing Friendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

October 1, 2014

Study Completion (Anticipated)

February 1, 2017

Study Registration Dates

First Submitted

July 29, 2014

First Submitted That Met QC Criteria

July 29, 2014

First Posted (Estimate)

July 30, 2014

Study Record Updates

Last Update Posted (Estimate)

July 30, 2014

Last Update Submitted That Met QC Criteria

July 29, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • z141100002114004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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