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

Primary Purpose

Acute Pancreatitis

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Dachaihu decoction compound

Rhubarb single medicine

Regular therapies

About this trial

This is an interventional treatment trial for Acute Pancreatitis focused on measuring Acute Pancreatitis, Dachaihu Decoction Compound, Rhubarb Single Medicine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

DDC(Dachaihu decoction compound) Group

RSM(rhubarb single medicine) Group

N Group

Arm Description

Treated with Dachaihu decoction compound and regular therapies

Treated with rhubarb single medicine and regular therapies

Treated with regular therapies and without traditional Chinese medicine

Outcomes

Primary Outcome Measures

Significant and effective rate

Significant and effective rate after 7 days of treatment

Secondary Outcome Measures

Full Information

NCT ID

NCT04990336

First Posted

July 27, 2021

Last Updated

March 22, 2022

Sponsor

Fifth Affiliated Hospital, Sun Yat-Sen University

1. Study Identification

Unique Protocol Identification Number

NCT04990336

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 1, 2023 (Anticipated)

Primary Completion Date

January 31, 2029 (Anticipated)

Study Completion Date

July 31, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fifth Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Pancreatitis

Keywords

Acute Pancreatitis, Dachaihu Decoction Compound, Rhubarb Single Medicine

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

306 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DDC(Dachaihu decoction compound) Group

Arm Type

Experimental

Arm Description

Treated with Dachaihu decoction compound and regular therapies

Arm Title

RSM(rhubarb single medicine) Group

Arm Type

Active Comparator

Arm Description

Treated with rhubarb single medicine and regular therapies

Arm Title

N Group

Arm Type

Other

Arm Description

Treated with regular therapies and without traditional Chinese medicine

Intervention Type

Combination Product

Intervention Name(s)

Dachaihu decoction compound

Intervention Description

Dachaihu decoction compound includes Bupleurum, Rhubarb, Citrus aurantium, Scutellaria, Pinellia, White Peony, Jujube, Ginger.

Intervention Type

Drug

Intervention Name(s)

Rhubarb single medicine

Intervention Description

Rhubarb single medicine

Intervention Type

Combination Product

Intervention Name(s)

Regular therapies

Intervention Description

Regular therapies, such as fluid therapy, for acute pancreatitis

Primary Outcome Measure Information:

Title

Significant and effective rate

Description

Significant and effective rate after 7 days of treatment

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Learn more about this trial

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

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