ClinicalTrials.gg
Status unknownNCT00506337Updated Jul 31, 2007

Evaluation of Effect of Integrated Treatment by Traditional Chinese and Western Medicine for Severe Acute Pancreatitis

A Phase 2/3 interventional study of Qingyi granules in Pancreatitis, Acute Necrotizing, sponsored by Tianjin Nankai Hospital. Status unknown at 3 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2007-07-31.

Sponsored by Tianjin Nankai Hospital · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2007), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

With multicenter randomized control clinical evaluation investigations, the scheme of integrated medicine treatment of severe acute pancreatitis (SAP) was further improved, and the therapeutic effects, safety and indications assured. Drawing in latest research fruits at home and abroad, a clinical practical guideline for integrated medicine of diagnosis and treatment of SAP would be formed, to be popularized all over China.

02

Conditions studied

  • Pancreatitis, Acute Necrotizing
03

In context

Pancreatitis, Acute Necrotizing

70 studies on the registry are indexed under Pancreatitis, Acute Necrotizing; 19 are open to participants now.

This study's planned enrollment of 300 is above the median of 70 across 45 interventional studies indexed under Pancreatitis, Acute Necrotizing.

Browse Pancreatitis, Acute Necrotizing studies →

Lead sponsor

Tianjin Nankai Hospital is the lead sponsor of 16 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patients 18yr-70yr, complying with the diagnostic standard of acute pancretitis (clinical symptoms and signs, elevated blood and urine amylase, and imaging criteria), conforming to 3 or more Ranson's criteria and APACHE-II score larger than 8, Balhazar CT score larger than 5.

Exclusion criteria

Exclusion Criteria:

  • Pregnancy, nursing mother, critical cases of advanced tumor, on the verge of death (estimated to be moral in 12h), severe visceral function disturbance, patients undergoing other therapeutic research that might interfere with the present study.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
300 participants (estimated)

Interventions

  • DrugQingyi granules

    Control group: The therapeutic methods accord to the concert schemes cited in the "Guides to diagnosis and treatment of severe acute pancreatitis" introduced by the Pancreatic Surgery Group of Surgical Chapter of Chinese Medical Association. Treatment group: In addition to the concert schemes cited in the "Guides to diagnosis and treatment of severe acute pancreatitis", during the first stage of the disease herbal Qingyi granules 1-B 4 bags dissolved in water 200ml were administered through the gastric tube q6h. Then the gastric tube was closed for 1h, and Qingyi granules 1-B another 4 bags dissolved in water 400ml were given through enema q6h. During the second stage (from the 2nd week to the 4th week after onset) Qingyi granules 2-B 2bags dissolved in water 200ml were added QD.

06

What researchers measure

Primary outcomes

  1. 1,Mortality 2,Morbidity 3,Crossing stage cure rates 4,Number of operation procedures 5,Incidences of secondary infections 6,Hospitalization days 7,Total expenses 8,Traditional Chinese medicine diagnostic parameters

    Time frame: To observe the relationship between the parameters of the first and second stages and the endpoints

Secondary outcomes

  1. 1.Routine laboratory tests, blood and urine amylase, blood lipase. 2.Important visceral function criteria 3.microorganism culture, endotoxin determination, CRP 4.B-ultrasound, CT, chest films, plain abdomen film

    Time frame: The above criteria should be tested on admission, and 24h, 48h and 72h later, 5d, 7d, and 2wks after admission, and on the day of discharge.

07

Study locations

3 of 3 sites recruiting
  • The 1st Affiliated Hospital, Dalian Medical Unversity
    Dalian, Liaoning 116011, China
    Recruiting
  • West China Hospital, Sichuan Unversity
    Chengdu, Sichuan 610041, China
    Recruiting
  • Tianjin Nankai Hospital
    Tianjin, 300100, China
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2006 and a completion of Oct 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 23, 2007
First posted
Jul 25, 2007
Start
Oct 2006
CompletionEst.
Oct 2009
Last update
Jul 31, 2007
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 31, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00506337
Lead sponsor
Tianjin Nankai Hospital
Collaborators
Sichuan University
First posted
Jul 25, 2007
Start date
Oct 2006
Completion
Oct 2009 (estimated)
Last update
Jul 31, 2007

Study contacts

Naiqiang Cui, Dr
Contact
cuinq@sohu.com
+86 22 27022268 ext. 3892
Naiqiang Cui, Dr
principal investigator · Tianjin Nankai Hospital
Qing Xia, Dr
principal investigator · West China Hospital
Qinghui Qi, Dr
principal investigator · The 1st Affiliated Hospital, Dalian Medical Unversity

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2007. You cannot join it, but the record below documents what was studied.

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