Acute PancreatitisPhase 1/2NCT02204189
The Clinical Study of Acute Pancreatitis Treated by TongFuSan
A Phase 1/2 study testing TongFuSan in people with Acute Pancreatitis, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine whether TongFuSan is effective in the treatment of acute pancreatitis with gastrointestinal dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- TongFuSan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Mar 2014to Feb 2017
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- clinical diagnosis of acute pancreatitis，both mild type and severe type
Who cannot join
- pregnant or suckling
- cancer in late time
- patient near death
Trial locations and contacts
1 site in 1 country.
Hong You, PHD contact
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100054
Hong You, PHD, 010-63139197
Wanzhen Xu, PHD, 010-63138049
About this study
Official title: The Clinical Study of Acute Pancreatitis With Gastrointestinal Dysfunction Treated by TongFuSan for External Application on ShenQue Acupoint
The purpose of this study is to determine whether TongFuSan is effective in the treatment of acute pancreatitis with gastrointestinal dysfunction.
Read the detailed description
- Patient who is diagnosed with acute pancreatitis(AP) should be included.
- Patients will be divided into two groups as random number table: control group(A) and experimental group(B).
- Group A will be given Mosapride po,and group B will be given TongFusan except for basic treatments of AP.
- Same investigator will write the case report form.
- Investigator will collect the patients' blood in three points: on admission, the third day and the seventh day.
- Otherwise, we need write down patients' clinical manifestation,Traditional Chinese Medicine differentiation, the result of clinical tests.
- When the patient discharge, we will write down the treatment measures, therapeutic effect, length of stay and the costs.
- Conditions
- Acute Pancreatitis
- Being tested
- TongFuSan
- Keywords
- acute pancreatitis, gastrointestinal dysfunction, TongFuSan, ShenQue acupoint
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TongFuSanDrug
TongFuSan 1g
| Study group | Role | What they receive |
|---|---|---|
| TongFuSan | Experimental | TongFuSan 1g per time, change every day, the duration is seven days Receives: Drug: TongFuSan |
What is being measured
The primary outcome is the main question the study is designed to answer.
the time of first defecation
Measured: ten days
Secondary outcomes (1)
the time of bowel sounds getting back to normal
Measured: ten days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study startMar 2014
- Primary completionOct 2014 (estimated)
- Study completionFeb 2017 (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.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, miaobin, Beijing Friendship Hospital
- Investigators
- Bin Miao, PHD, Study chair, Beijing Friendship HospitalHong Wang, Graduate, Study director, Beijing Friendship HospitalShuwen Zhang, bachelor, Study director, Beijing Friendship HospitalChao Wang, PHD, Principal investigator, Beijing Friendship HospitalYanli Su, PHD, Principal investigator, Beijing Friendship HospitalShirong Li, graduate, Principal investigator, Beijing Friendship HospitalFengwu Li, graduate, Principal investigator, Beijing Friendship HospitalDinghua Xu, graduate, Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02204189
- Sponsor's protocol ID
- z141100002114004
- Status last verified
- Jul 2014
- First submitted
- 29 Jul 2014
- Last updated
- 30 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Study of Acute Pancreatitis With Gastrointestinal Dysfunction Treated by TongFuSan for External Application on ShenQue Acupoint
- ClinicalTrials.gov ID
- NCT02204189
- Acronym / sponsor ID
- z141100002114004
- Conditions
- Acute Pancreatitis
- Keywords
- acute pancreatitis, gastrointestinal dysfunction, TongFuSan, ShenQue acupoint
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 30 Jul 2014 (estimated)
- 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.
The purpose of this study is to determine whether TongFuSan is effective in the treatment of acute pancreatitis with gastrointestinal dysfunction.
Detailed description
- Patient who is diagnosed with acute pancreatitis(AP) should be included.
- Patients will be divided into two groups as random number table: control group(A) and experimental group(B).
- Group A will be given Mosapride po,and group B will be given TongFusan except for basic treatments of AP.
- Same investigator will write the case report form.
- Investigator will collect the patients' blood in three points: on admission, the third day and the seventh day.
- Otherwise, we need write down patients' clinical manifestation,Traditional Chinese Medicine differentiation, the result of clinical tests.
- When the patient discharge, we will write down the treatment measures, therapeutic effect, length of stay and the costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TongFuSan | Experimental | Drug: TongFuSanTongFuSan 1g per time, change every day, the duration is seven days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- clinical diagnosis of acute pancreatitis，both mild type and severe type
Key exclusion criteria (3 listed)
- pregnant or suckling
- cancer in late time
- patient near death
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 |
|---|---|---|
| TongFuSanTongFuSan 1g | Drug | TongFuSan |
Primary outcome
the time of first defecation
Time frame: ten days
1 secondary outcome
the time of bowel sounds getting back to normal
Time frame: ten days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2014.
Related trials for Acute Pancreatitis
Recruiting
Efferon LPS Hemoadsorption in Patients With Acute Pancreatitis
Pancreatitis, Acute
Recruiting
Timing of CHolecystectomy In Severe PAncreatitis
Acute Pancreatitis, Cholelithiasis
Not yet recruiting
Cold Water Papillary Irrigation Plus Rectal NSAIDs vs Rectal NSAIDs Alone for Post-ERCP Pancreatitis (COLD)
Post ERCP Pancreatitis, Acute Pancreatitis (AP)
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
RecruitingPhase 1/2
Soy Tomato Juice to Improve Outcomes in Pancreatitis
Recurrent Acute Pancreatitis, Chronic Pancreatitis
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. This study is not recruiting at the moment.
Hong You, PHD contact
Bin Miao, PHD study chair
Beijing Friendship Hospital
Hong Wang, Graduate study director
Beijing Friendship Hospital
Shuwen Zhang, bachelor study director
Beijing Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TongFuSan in people with Acute Pancreatitis, run by Beijing Friendship Hospital at 1 site in China.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 30 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hong You, PHD (010-63139197), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the time of first defecation (time frame: ten 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 30 Jul 2014.