Dachaihu Decoction Compound and Rhubarb Single Medicine in the Treatment of Acute Pancreatitis

March 22, 2022 updated by: Fifth Affiliated Hospital, Sun Yat-Sen University

Comparison of Clinical Efficacy of Dachaihu Decoction Compound and Rhubarb Single Medicine in the Treatment of Acute Pancreatitis

A large number of clinical studies have shown that oral administration, external application or enema of Chinese medicine can promote the recovery of gastrointestinal function and the absorption of pancreatic inflammation. The aims of the study is to explore the application of Dachaihu Decoction Compound (DDC)and Rhubarb Single Medicine (RSM) in the Treatment of Acute Pancreatitis.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

306

Phase

  • Not Applicable

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age from 18 to 65 years old
  • Meet the diagnostic criteria of western medicine for acute pancreatitis, within 48 hours of onset
  • Consent of the subjects, who sign the informed consent form

Exclusion Criteria:

  • Women who are pregnant or breastfeeding
  • Acute abdomen such as organic intestinal obstruction, gastrointestinal perforation, purulent cholangitis, etc.
  • Patients with a history of severe heart, liver, kidney and other important organ diseases
  • Patients with mental illness and malignant tumors
  • People who have allergies, or are allergic to a certain drug ingredient

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DDC(Dachaihu decoction compound) Group
Treated with Dachaihu decoction compound and regular therapies
Combination product: Dachaihu decoction compound
Dachaihu decoction compound includes Bupleurum, Rhubarb, Citrus aurantium, Scutellaria, Pinellia, White Peony, Jujube, Ginger.
Combination product: Regular therapies
Regular therapies, such as fluid therapy, for acute pancreatitis
Active Comparator: RSM(rhubarb single medicine) Group
Treated with rhubarb single medicine and regular therapies
Combination product: Regular therapies
Regular therapies, such as fluid therapy, for acute pancreatitis
Drug: Rhubarb single medicine
Rhubarb single medicine
Other: N Group
Treated with regular therapies and without traditional Chinese medicine
Combination product: Regular therapies
Regular therapies, such as fluid therapy, for acute pancreatitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Significant and effective rate
Time Frame: 7 days
Significant and effective rate after 7 days of treatment
7 days

Collaborators and Investigators

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

Sponsor

Fifth Affiliated Hospital, Sun Yat-Sen University

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 (Anticipated)

September 1, 2023

Primary Completion (Anticipated)

January 31, 2029

Study Completion (Anticipated)

July 31, 2029

Study Registration Dates

First Submitted

July 27, 2021

First Submitted That Met QC Criteria

July 27, 2021

First Posted (Actual)

August 4, 2021

Study Record Updates

Last Update Posted (Actual)

March 24, 2022

Last Update Submitted That Met QC Criteria

March 22, 2022

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZDWY.XHNK.003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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