ClinicalTrials.gg
RecruitingNCT06872034Updated Jul 16, 2025

The Efficacy and Safety of Venostan in Promoting Postoperative Swelling Reduction in Patients With Ankle Fractures

An interventional study of Venostasin (horse chestnut seed extract tablets) and standard treatment in Swelling/ Edema, sponsored by Beijing Jishuitan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-16.

Sponsored by Beijing Jishuitan Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2026, 10 months ago, but the record still lists the study as recruiting.
  • Started Apr 2025; still recruiting 1 year 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
290
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 11 studies in Edema with a site in China — 4 open to participants now, 4 under way, 1 of them phase 3. Edema · China.

Planned enrollment
2nd of 10
290 · median 117
Started
2025
with 2 others
No phase
5 of 11
2 open now
Registered
9th of 11
by date
Lead sponsor
1 of 11
Beijing Jishuitan Hospital

Among the 11 studies in Edema with a site in China, this one is the 2nd largest by planned enrollment of the 10 interventional ones that give a count, is one of 3 that started in 2025, is one of 5 with no phase, and was the 9th registered.

Edema

566 studies on the registry are indexed under Edema; 95 are open to participants now.

Browse Edema studies →

Open to participants now

4 of the 11 studies in Edema with a site in China are open now. Recruiting first, the newest first:

All 4 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 56 Edema studies recruiting now, 34 (61%) set no upper age limit and 16 (29%) stop at 75 or younger; 8 take children under 18; 4 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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02

Study 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. 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.

03

Conditions studied

  • Swelling/ Edema

Keywords

  • Ankle fracture
  • Edema
  • Postoperative rehabilitation
  • horse chestnut seed extract
  • venostan
  • enhanced recovery after surgery
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ≥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 form.

Exclusion criteria

Exclusion Criteria:

  • Pregnant or lactating women;
  • With 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;
  • 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 drug;
  • Any contraindications that limit clinical evaluation and treatment of the patient;
  • Deemed unsuitable for inclusion in this study by the investigator.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
290 participants (estimated)

Study arms

  • Experimental
    Venostan (horse chestnut seed extract tablets)

    Drug: Venostasin (horse chestnut seed extract tablets) · Other: standard treatment

  • Other
    control

    Other: standard treatment

Interventions

  • DrugVenostasin (horse chestnut seed extract tablets)

    Venostasin (horse chestnut seed extract tablets) ,twice daily, 400 mg per dose, for 14 days

  • Otherstandard treatment

    standard treatment

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: from enrollment to the 6th day postoperation

Secondary outcomes

  1. 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)

    Time frame: from enrollment to the 14th day postoperation

  2. 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)

    Time frame: from enrollment to the 14th day postoperation

  3. 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

    Time frame: from enrollment to the 14th day postoperation

  4. 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

    Time frame: from enrollment to the 14th day postoperation

  5. 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)

    Time frame: from enrollment to the 14th day postoperation

  6. 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

    Time frame: from enrollment to the 14th day postoperation

  7. 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

    Time frame: from enrollment to 30 days after discontinuation of medication

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2025 (actual). Primary completion is estimated for Jan 2026, 8 months after the start.

Of 153 non-industry interventional studies with no phase under Edema, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 24. This study's planned 8 months is below that.

Counting every sponsor, half of 168 studies reached it within 11 months; a quarter within 6 and three quarters within 24.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 27, 2025
First posted
Mar 12, 2025
StartActual
Apr 16, 2025
Primary completionEst.
Jan 12, 2026
CompletionEst.
Jan 12, 2026
Last update
Jul 16, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06872034
Lead sponsor
Beijing Jishuitan Hospital
Responsible party
LiTing (Chief Physician, Beijing Jishuitan Hospital) — Principal investigator
First posted
Mar 12, 2025
Start date
Apr 16, 2025
Primary completion
Jan 12, 2026 (estimated)
Completion
Jan 12, 2026 (estimated)
Last update
Jul 16, 2025

Study contacts

Ting Li
Contact
liting2000@sina.com
86-010-58517207

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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