Swelling/ EdemaNCT06872034
The Efficacy and Safety of Venostan in Promoting Postoperative Swelling Reduction in Patients With Ankle Fractures
A study testing Venostasin (horse chestnut seed extract tablets) and standard treatment in people with Swelling/ Edema, run by Beijing Jishuitan Hospital at 1 site in China.
Trial summary
This study is a multicenter, open-label, randomized controlled trial planned to enroll patients with ankle fractures who meet the inclusion and exclusion criteria and are scheduled to undergo internal fixation surgery from the emergency and inpatient wards of multiple hospitals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Swelling/ Edema
- What is being tested?
- Venostasin (horse chestnut seed extract tablets) and standard treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteChina
- Study dates
- 16 Apr 2025to 12 Jan 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 year old, no gender restriction;
- Diagnosed with ankle fracture confirmed by imaging data, AO classification: ---AO-43, AO-44-F3, AO-44;
- Scheduled to undergo open reduction and internal fixation surgery;
- Voluntary signing of the informed consent form.
Who cannot join
- Pregnant or lactating women;
- With contraindications to surgery;
- With other severe combined injuries or soft tissue infections;
- Severe multiple trauma: Injury Severity Score (ISS) > 16;
- With concurrent fractures of the spine, pelvis, or ipsilateral or contralateral lower limbs;
- Pathological fractures;
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- With peripheral vascular disease or deep vein thrombosis (DVT);
- With severe impairment of heart, lung, liver, or kidney function or abnormal coagulation function;
- Unable to walk independently before the injury;
- With pre-existing lower limb edema (e.g., due to liver cirrhosis, kidney disease, etc.) before the injury;
- With mental disorders or hyperalgesia;
- Allergic to any component of the investigational drug;
- Any contraindications that limit clinical evaluation and treatment of the patient;
- Deemed unsuitable for inclusion in this study 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, 1 recruiting
- Recruiting
Beijing Jishuitan Hospital
Beijing, 100035
Ting Li, 010-58516688, jishuitan3@wjw.beijing.gov.cn
Li
About this study
Official title: The Efficacy and Safety of Venostan (Horse Chestnut Seed Extract Tablets) in Promoting Postoperative Swelling Reduction in Patients With Ankle Fractures: A Multicenter, Open-Label, Randomized Controlled Trial
This study is a multicenter, open-label, randomized controlled trial planned to enroll patients with ankle fractures who meet the inclusion and exclusion criteria and are scheduled to undergo internal fixation surgery from the emergency and inpatient wards of multiple hospitals. General and disease-related data will be collected. All eligible patients must voluntarily sign an informed consent form after understanding and accepting the study. Successfully recruited participants will undergo internal fixation surgery at a scheduled time and then be randomly assigned to either the Venostan (horse chestnut seed extract tablet) group or the conventional treatment group. They will receive the corresponding treatments according to the study protocol. Follow-up assessments will include changes in ankle circumference, ankle range of motion, scale evaluation results, laboratory test results, and adverse events. The study aims to evaluate the effects of Venostasin in patients with ankle fractures undergoing internal fixation surgery, exploring its potential to promote postoperative reduction of ankle swelling, enhance early joint function recovery, and investigate its safety in postoperative fracture management.
- Conditions
- Swelling/ Edema
- Being tested
- Venostasin (horse chestnut seed extract tablets), standard treatment
- Keywords
- Ankle fracture, Edema, Postoperative rehabilitation, horse chestnut seed extract, venostan, enhanced recovery after surgery
- Medical subject headings
- Edema, Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venostasin (horse chestnut seed extract tablets)Drug
Venostasin (horse chestnut seed extract tablets) ，twice daily, 400 mg per dose, for 14 days
standard treatmentOther
standard treatment
| Study group | Role | What they receive |
|---|---|---|
| Venostan (horse chestnut seed extract tablets) | Experimental | Not described Receives: Drug: Venostasin (horse chestnut seed extract tablets); Other: standard treatment |
| control | Other | Not described Receives: Other: standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ankle circumference at 6 days postoperatively compared to baseline
Defined as the change in ankle circumference measured using the figure-of-eight method on postoperative day 6 (after 5 days of Venostan treatment) compared to the ankle circumference measured on postoperative day 2 (before the first dose of Venostan)
Measured: from enrollment to the 6th day postoperation
Secondary outcomes (7)
Change in ankle circumference at 14 days postoperatively compared to baseline
Defined as the change in ankle circumference measured using the figure-of-eight method on postoperative day 14 (after 13 days of Venostan treatment) compared to the ankle circumference measured on postoperative day 2 (before the first dose of Venostan)
Measured: from enrollment to the 14th day postoperation
Percentage change in ankle circumference at 6 and 14 days postoperatively compared to baseline
Defined as the percentage change in ankle circumference measured using the figure-of-eight method on postoperative days 6 and 14 (after 5 and 13 days of Venostan treatment, respectively) compared to the ankle circumference measured on postoperative day 2 (before the first dose of Venostan)
Measured: from enrollment to the 14th day postoperation
Change in Visual Analog Scale (VAS) pain score at 6 and 14 days postoperatively
Defined as the change in the patient-reported Visual Analog Scale (VAS) pain score on postoperative days 6 and 14 (after 5 and 13 days of Venostan treatment, respectively) compared to the score on postoperative day 2，VAS range from 0 to 10, and higher scores mean a worse outcome
Measured: from enrollment to the 14th day postoperation
EuroQol-5 dimension (EQ-5D) score at 6 and 14 days postoperatively
Defined as the EuroQol-5 dimension (EQ-5D) quality of life score reported by the patient on postoperative days 6 and 14 (after 5 and 13 days of Venostan treatment, respectively), EQ-5D consists of 5 dimension, and every dimension consists of 5 level, the higher lever means a worse outcome
Measured: from enrollment to the 14th day postoperation
Ankle range of motion at 6 and 14 days postoperatively
Defined as the ankle range of motion assessed by the investigator through physical examination on postoperative days 6 and 14 (after 5 and 13 days of Venostan treatment, respectively)
Measured: from enrollment to the 14th day postoperation
Incidence of deep vein thrombosis (DVT) in the lower limbs within 14 days postoperatively
Defined as the incidence of deep vein thrombosis (DVT) detected by lower limb vascular ultrasound within 14 days postoperatively
Measured: from enrollment to the 14th day postoperation
Rate of surgical complications
Defined as complications related to the fracture surgery, with the severity of complications assessed by the investigator using the Clavien-Dindo classification of surgical complications
Measured: from enrollment to 30 days after discontinuation of medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start16 Apr 2025
- Primary completion12 Jan 2026 (estimated)
- Study completion12 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Swelling/ EdemaStudies 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
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Jishuitan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LiTing, Beijing Jishuitan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06872034
- Sponsor's protocol ID
- K2025-003-00
- Status last verified
- Apr 2025
- First submitted
- 27 Feb 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- 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 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Venostan (Horse Chestnut Seed Extract Tablets) in Promoting Postoperative Swelling Reduction in Patients With Ankle Fractures: A Multicenter, Open-Label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06872034
- Acronym / sponsor ID
- K2025-003-00
- Conditions
- Swelling/ Edema
- Keywords
- Ankle fracture, Edema, Postoperative rehabilitation, horse chestnut seed extract, venostan, enhanced recovery after surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Beijing Jishuitan HospitalUniversity, hospital or other
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- 12 Jan 2026 (estimated)
- Study completion
- 12 Jan 2026 (estimated)
- First posted
- 12 Mar 2025 (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.
This study is a multicenter, open-label, randomized controlled trial planned to enroll patients with ankle fractures who meet the inclusion and exclusion criteria and are scheduled to undergo internal fixation surgery from the emergency and inpatient wards of multiple hospitals. General and disease-related data will be collected. All eligible patients must voluntarily sign an informed consent form after understanding and accepting the study. Successfully recruited participants will undergo internal fixation surgery at a scheduled time and then be randomly assigned to either the Venostan (horse chestnut seed extract tablet) group or the conventional treatment group. They will receive the corresponding treatments according to the study protocol. Follow-up assessments will include changes in ankle circumference, ankle range of motion, scale evaluation results, laboratory test results, and adverse events. The study aims to evaluate the effects of Venostasin in patients with ankle fractures undergoing internal fixation surgery, exploring its potential to promote postoperative reduction of ankle swelling, enhance early joint function recovery, and investigate its safety in postoperative fracture management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Venostan (horse chestnut seed extract tablets) | Experimental | Drug: Venostasin (horse chestnut seed extract tablets), Other: standard treatment |
| control | Other | Other: standard treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥18 year old, no gender restriction;
- Diagnosed with ankle fracture confirmed by imaging data, AO classification: ---AO-43, AO-44-F3, AO-44;
- Scheduled to undergo open reduction and internal fixation surgery;
- Voluntary signing of the informed consent form.
Key exclusion criteria (14 listed)
- Pregnant or lactating women;
- With contraindications to surgery;
- With other severe combined injuries or soft tissue infections;
- Severe multiple trauma: Injury Severity Score (ISS) > 16;
- With concurrent fractures of the spine, pelvis, or ipsilateral or contralateral lower limbs;
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 |
|---|---|---|
| Venostasin (horse chestnut seed extract tablets)Venostasin (horse chestnut seed extract tablets) ，twice daily, 400 mg per dose, for 14 days | Drug | Venostan (horse chestnut seed extract tablets) |
| standard treatmentstandard treatment | Other | Venostan (horse chestnut seed extract tablets), control |
Primary outcome
Change in ankle circumference at 6 days postoperatively compared to baseline
Time frame: from enrollment to the 6th day postoperation
Defined as the change in ankle circumference measured using the figure-of-eight method on postoperative day 6 (after 5 days of Venostan treatment) compared to the ankle circumference measured on postoperative day 2 (before the first dose of Venostan)
7 secondary outcomes
Change in ankle circumference at 14 days postoperatively compared to baseline
Time frame: from enrollment to the 14th day postoperation
Percentage change in ankle circumference at 6 and 14 days postoperatively compared to baseline
Time frame: from enrollment to the 14th day postoperation
Change in Visual Analog Scale (VAS) pain score at 6 and 14 days postoperatively
Time frame: from enrollment to the 14th day postoperation
EuroQol-5 dimension (EQ-5D) score at 6 and 14 days postoperatively
Time frame: from enrollment to the 14th day postoperation
Ankle range of motion at 6 and 14 days postoperatively
Time frame: from enrollment to the 14th day postoperation
Incidence of deep vein thrombosis (DVT) in the lower limbs within 14 days postoperatively
Time frame: from enrollment to the 14th day postoperation
Rate of surgical complications
Time frame: from enrollment to 30 days after discontinuation of medication
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 16 Jul 2025.
- 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 study testing Venostasin (horse chestnut seed extract tablets) and standard treatment in people with Swelling/ Edema, run by Beijing Jishuitan 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 4 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 16 Jul 2025. 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.
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 Ting Li (86-010-58517207, liting2000@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ankle circumference at 6 days postoperatively compared to baseline (time frame: from enrollment to the 6th day postoperation). 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 16 Jul 2025.