Gastrointestinal BleedingEarly Phase 1NCT07339956
Yiwei Jiaohuang Ointment for Gastrointestinal Bleeding Associated With Oral Antithrombotic Agents
A Early Phase 1 study testing A Chinese herb formula--Yiwei Jiaohuang Onitment and Rabeprazole Enteric-Coated Tablets in people with Gastrointestinal Bleeding, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the clinical efficacy and safety of YiWei Jiaohuang Ointment in treating gastrointestinal bleeding associated with oral antithrombotic therapy. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Gastrointestinal Bleeding
- What is being tested?
- A Chinese herb formula--Yiwei Jiaohuang Onitment and Rabeprazole Enteric-Coated Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2026to 30 Aug 2026
- Phase
- Early Phase 1
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Oral therapy with at least one antiplatelet or anticoagulant agent, including: aspirin, clopidogrel, ticagrelor, prasugrel, warfarin, rivaroxaban, apixaban, edoxaban, dabigatran, etc.;
- BARC stage 1 or 2;
- Traditional Chinese Medicine pattern identified as phlegm-heat and blood stasis obstruction syndrome;
- Age 18-90 years;
- Signed informed consent.
Who cannot join
- Patients with gastrointestinal bleeding resulting in hemoglobin levels <20 g/L and/or requiring hospitalization;
- Gastrointestinal malignancies;
- Cases where the source of occult blood cannot be distinguished, such as fresh bleeding from hemorrhoids;
- Concurrent use of hemostatic traditional Chinese medicine preparations like Yunnan Baiyao;
- Significant liver or kidney dysfunction, with ALT, AST, or serum creatinine exceeding three times the upper limit of normal;
- Pregnant women, women planning pregnancy, or lactating women;
- Individuals deemed unsuitable for this clinical trial by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
China-Japan Friendship Hospital
Beijing
Jie Zhang, +86 15652385971, zhangjie9496@bucm.edu.cn
About this study
Official title: Yiwei Jiaohuang Ointment for Gastrointestinal Bleeding Associated With Oral Antithrombotic Agents: A Randomized Controlled Trial
The goal of this clinical trial is to evaluate the clinical efficacy and safety of YiWei Jiaohuang Ointment in treating gastrointestinal bleeding associated with oral antithrombotic therapy. The main question it aims to answer is:
Does Yiwei JiaoHuang Ointment accelerate the conversion to negative results in fecal occult blood tests among patients with gastrointestinal bleeding associated with antithrombotic therapy? Researchers will compare use rabeprazole alone as routine therapy to see if Yiwei JiaoHuang Ointment can accelerate the conversion to negative results in fecal occult blood tests.
Participants will ： Take Yiwei JiaoHuang Ointment every day for 2 weeks. Return to the hospital for a fecal occult blood test after 3 days, 1 week, and 2 weeks of medication.
- Conditions
- Gastrointestinal Bleeding
- Being tested
- A Chinese herb formula--Yiwei Jiaohuang Onitment, Rabeprazole Enteric-Coated Tablets
- Keywords
- Antithrombotic therapy, Traditional Chinese Medicine
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Chinese herb formula--Yiwei Jiaohuang OnitmentDrug
Yiwei Jiaohuang Onitment consists of four Chinese herbs: 3g of Duyiwei（Lamiophlomis Herb）, 3g of raw Da Huang(Rhubarb Root and Rhizome (Unprocessed)), 6g of Bai Ji(Bletilla Rhizome) and 10g of Ejiao (donkey-hide gelatin). Prepared as ointment, patients should take one dose daily in the morning on an empty stomach for 2 weeks.
Rabeprazole Enteric-Coated TabletsDrug
Rabeprazole Enteric-Coated Tablets10mg once a day for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Drug: A Chinese herb formula--Yiwei Jiaohuang Onitment; Drug: Rabeprazole Enteric-Coated Tablets |
| Control | Active comparator | Not described Receives: Drug: Rabeprazole Enteric-Coated Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of negative fecal occult blood test results in the two groups of patients after 2 weeks of intervention.
Measured: two weeks of intervention
Secondary outcomes (4)
Time required for fecal occult blood to turn negative in two groups of patients.
Measured: two weeks of intervention
The rate of negative fecal occult blood test results in the two groups of patients after 3 days of intervention.
Measured: 3 days of intervention
The rate of negative fecal occult blood test results in the two groups of patients after one week of intervention.
Measured: one week of intervention
Changes in hemoglobin levels in two groups of patients after 2 weeks of intervention.
Measured: two weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start10 Jan 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal BleedingStudies of the same condition, open and under way.
- More trials run by China-Japan 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie, Zhang, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07339956
- Sponsor's protocol ID
- 2025-NHLHCRF-PY-31
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 26 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yiwei Jiaohuang Ointment for Gastrointestinal Bleeding Associated With Oral Antithrombotic Agents: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07339956
- Acronym / sponsor ID
- 2025-NHLHCRF-PY-31
- Conditions
- Gastrointestinal Bleeding
- Keywords
- Antithrombotic therapy, Traditional Chinese Medicine
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 10 Jan 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 14 Jan 2026 (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.
The goal of this clinical trial is to evaluate the clinical efficacy and safety of YiWei Jiaohuang Ointment in treating gastrointestinal bleeding associated with oral antithrombotic therapy. The main question it aims to answer is:
Does Yiwei JiaoHuang Ointment accelerate the conversion to negative results in fecal occult blood tests among patients with gastrointestinal bleeding associated with antithrombotic therapy? Researchers will compare use rabeprazole alone as routine therapy to see if Yiwei JiaoHuang Ointment can accelerate the conversion to negative results in fecal occult blood tests.
Participants will ： Take Yiwei JiaoHuang Ointment every day for 2 weeks. Return to the hospital for a fecal occult blood test after 3 days, 1 week, and 2 weeks of medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: A Chinese herb formula--Yiwei Jiaohuang Onitment, Drug: Rabeprazole Enteric-Coated Tablets |
| Control | Active comparator | Drug: Rabeprazole Enteric-Coated Tablets |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Oral therapy with at least one antiplatelet or anticoagulant agent, including: aspirin, clopidogrel, ticagrelor, prasugrel, warfarin, rivaroxaban, apixaban, edoxaban, dabigatran, etc.;
- BARC stage 1 or 2;
- Traditional Chinese Medicine pattern identified as phlegm-heat and blood stasis obstruction syndrome;
- Age 18-90 years;
- Signed informed consent.
Key exclusion criteria (7 listed)
- Patients with gastrointestinal bleeding resulting in hemoglobin levels <20 g/L and/or requiring hospitalization;
- Gastrointestinal malignancies;
- Cases where the source of occult blood cannot be distinguished, such as fresh bleeding from hemorrhoids;
- Concurrent use of hemostatic traditional Chinese medicine preparations like Yunnan Baiyao;
- Significant liver or kidney dysfunction, with ALT, AST, or serum creatinine exceeding three times the upper limit of normal;
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 |
|---|---|---|
| A Chinese herb formula--Yiwei Jiaohuang OnitmentYiwei Jiaohuang Onitment consists of four Chinese herbs: 3g of Duyiwei（Lamiophlomis Herb）, 3g of raw Da Huang(Rhubarb Root and Rhizome (Unprocessed)), 6g of Bai Ji(Bletilla Rhizome) and 10g of Ejiao (donkey-hide gelatin). Prepared as ointment, patients should take one dose daily in the morning on an empty stomach for 2 weeks. | Drug | Intervention |
| Rabeprazole Enteric-Coated TabletsRabeprazole Enteric-Coated Tablets10mg once a day for 2 weeks | Drug | Control, Intervention |
Primary outcome
The rate of negative fecal occult blood test results in the two groups of patients after 2 weeks of intervention.
Time frame: two weeks of intervention
4 secondary outcomes
Time required for fecal occult blood to turn negative in two groups of patients.
Time frame: two weeks of intervention
The rate of negative fecal occult blood test results in the two groups of patients after 3 days of intervention.
Time frame: 3 days of intervention
The rate of negative fecal occult blood test results in the two groups of patients after one week of intervention.
Time frame: one week of intervention
Changes in hemoglobin levels in two groups of patients after 2 weeks of intervention.
Time frame: two weeks of intervention
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 26 Jan 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing A Chinese herb formula--Yiwei Jiaohuang Onitment and Rabeprazole Enteric-Coated Tablets in people with Gastrointestinal Bleeding, run by China-Japan 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 5 inclusion and 7 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 26 Jan 2026. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Jie Zhang (+86 15652385971, zhangjie9496@bucm.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of negative fecal occult blood test results in the two groups of patients after 2 weeks of intervention. (time frame: two weeks of intervention). 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 26 Jan 2026.