NCT02204189

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 30, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

July 30, 2014

Status Verified

July 1, 2014

Enrollment Period

7 months

First QC Date

July 29, 2014

Last Update Submit

July 29, 2014

Conditions

Acute Pancreatitis

Keywords

acute pancreatitisgastrointestinal dysfunctionTongFuSanShenQue acupoint

Outcome Measures

Primary Outcomes (1)

  • the time of first defecation

    ten days

Secondary Outcomes (1)

  • the time of bowel sounds getting back to normal

    ten days

Other Outcomes (1)

  • Hospitalization cost

    ten days

Study Arms (1)

TongFuSan

EXPERIMENTAL

TongFuSan 1g per time, change every day, the duration is seven days

Drug: TongFuSan

Interventions

TongFuSanDRUG

TongFuSan 1g

TongFuSan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • pregnant or suckling
  • cancer in late time
  • patient near death

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100054, China

RECRUITING

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Study Officials

  • Bin Miao, PHD

    Beijing Friendship Hospital

    STUDY CHAIR

  • Hong Wang, Graduate

    Beijing Friendship Hospital

    STUDY DIRECTOR

  • Shuwen Zhang, bachelor

    Beijing Friendship Hospital

    STUDY DIRECTOR

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hong You, PHD

CONTACT

010-63139197

Bin Miao, PHD

CONTACT

18612252085miaobin0105@126.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate chief physician

Study Record Dates

First Submitted

July 29, 2014

First Posted

July 30, 2014

Study Start

March 1, 2014

Primary Completion

October 1, 2014

Study Completion

February 1, 2017

Last Updated

July 30, 2014

Record last verified: 2014-07

Locations

CN(1)