NCT04990336

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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
306

participants targeted

Target at P75+ for not_applicable

Timeline
36mo left

Started Sep 2023

Longer than P75 for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress49%
Sep 2023Jul 2029

First Submitted

Initial submission to the registry

July 27, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 4, 2021

Completed
2.1 years until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2029

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2029

Last Updated

March 24, 2022

Status Verified

July 1, 2021

Enrollment Period

5.4 years

First QC Date

July 27, 2021

Last Update Submit

March 22, 2022

Conditions

Keywords

Acute PancreatitisDachaihu Decoction CompoundRhubarb Single Medicine

Outcome Measures

Primary Outcomes (1)

  • Significant and effective rate

    Significant and effective rate after 7 days of treatment

    7 days

Study Arms (3)

DDC(Dachaihu decoction compound) Group

EXPERIMENTAL

Treated with Dachaihu decoction compound and regular therapies

Combination Product: Dachaihu decoction compoundCombination Product: Regular therapies

RSM(rhubarb single medicine) Group

ACTIVE COMPARATOR

Treated with rhubarb single medicine and regular therapies

Drug: Rhubarb single medicineCombination Product: Regular therapies

N Group

OTHER

Treated with regular therapies and without traditional Chinese medicine

Combination Product: Regular therapies

Interventions

Dachaihu decoction compoundCOMBINATION_PRODUCT

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

DDC(Dachaihu decoction compound) Group

Rhubarb single medicine

RSM(rhubarb single medicine) Group
Regular therapiesCOMBINATION_PRODUCT

Regular therapies, such as fluid therapy, for acute pancreatitis

DDC(Dachaihu decoction compound) GroupN GroupRSM(rhubarb single medicine) Group

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2021

First Posted

August 4, 2021

Study Start

September 1, 2023

Primary Completion (Estimated)

January 31, 2029

Study Completion (Estimated)

July 31, 2029

Last Updated

March 24, 2022

Record last verified: 2021-07