The Clinical Study of Acute Pancreatitis Treated by TongFuSan

Acute Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02204189
• Other study ID #: z141100002114004
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: July 29, 2014
• Last updated: July 29, 2014
• Start date: March 2014
• Est. completion date: February 2017

Study information

• Verified date: July 2014
• Source: Beijing Friendship Hospital
• Contact: Hong You, PHD
• Phone: 010-63139197
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2017
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Intervention

Drug:
• TongFuSan
TongFuSan 1g

Locations

Country	Name	City	State
China	Beijing Friendship Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hospitalization cost		ten days	No
Primary	the time of first defecation		ten days	No
Secondary	the time of bowel sounds getting back to normal		ten days	No