Acute PancreatitisNCT04990336
Dachaihu Decoction Compound and Rhubarb Single Medicine in the Treatment of Acute Pancreatitis
A study testing Dachaihu decoction compound, Rhubarb single medicine and Regular therapies in people with Acute Pancreatitis, run by Fifth Affiliated Hospital, Sun Yat-Sen University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- Dachaihu decoction compound, Rhubarb single medicine and Regular therapies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 31 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Acute Pancreatitis
- Being tested
- Dachaihu decoction compound, Rhubarb single medicine, Regular therapies
- Keywords
- Acute Pancreatitis, Dachaihu Decoction Compound, Rhubarb Single Medicine
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dachaihu decoction compoundCombination product
Dachaihu decoction compound includes Bupleurum, Rhubarb, Citrus aurantium, Scutellaria, Pinellia, White Peony, Jujube, Ginger.
Rhubarb single medicineDrug
Rhubarb single medicine
Regular therapiesCombination product
Regular therapies, such as fluid therapy, for acute pancreatitis
| Study group | Role | What they receive |
|---|---|---|
| DDC(Dachaihu decoction compound) Group | Experimental | Treated with Dachaihu decoction compound and regular therapies Receives: Combination Product: Dachaihu decoction compound; Combination Product: Regular therapies |
| RSM(rhubarb single medicine) Group | Active comparator | Treated with rhubarb single medicine and regular therapies Receives: Drug: Rhubarb single medicine; Combination Product: Regular therapies |
| N Group | Other | Treated with regular therapies and without traditional Chinese medicine Receives: Combination Product: Regular therapies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant and effective rate
Significant and effective rate after 7 days of treatment
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start1 Sep 2023 (estimated)
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 306 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04990336
- Sponsor's protocol ID
- ZDWY.XHNK.003
- Status last verified
- Jul 2021
- First submitted
- 27 Jul 2021
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Efficacy of Dachaihu Decoction Compound and Rhubarb Single Medicine in the Treatment of Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT04990336
- Acronym / sponsor ID
- ZDWY.XHNK.003
- Conditions
- Acute Pancreatitis
- Keywords
- Acute Pancreatitis, Dachaihu Decoction Compound, Rhubarb Single Medicine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 306 participants (estimated)
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 4 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DDC(Dachaihu decoction compound) Group | Experimental | Combination Product: Dachaihu decoction compound, Combination Product: Regular therapiesTreated with Dachaihu decoction compound and regular therapies |
| RSM(rhubarb single medicine) Group | Active comparator | Drug: Rhubarb single medicine, Combination Product: Regular therapiesTreated with rhubarb single medicine and regular therapies |
| N Group | Other | Combination Product: Regular therapiesTreated with regular therapies and without traditional Chinese medicine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dachaihu decoction compoundDachaihu decoction compound includes Bupleurum, Rhubarb, Citrus aurantium, Scutellaria, Pinellia, White Peony, Jujube, Ginger. | Combination product | DDC(Dachaihu decoction compound) Group |
| Rhubarb single medicineRhubarb single medicine | Drug | RSM(rhubarb single medicine) Group |
| Regular therapiesRegular therapies, such as fluid therapy, for acute pancreatitis | Combination product | DDC(Dachaihu decoction compound) Group, N Group, RSM(rhubarb single medicine) Group |
Primary outcome
Significant and effective rate
Time frame: 7 days
Significant and effective rate after 7 days of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Dachaihu decoction compound, Rhubarb single medicine and Regular therapies in people with Acute Pancreatitis, run by Fifth Affiliated Hospital, Sun Yat-Sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant and effective rate (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022.