CClinicalTrials.gg
CompletedNCT06753448Updated Jul 15, 2025

Efficacy of Diosmin and Hesperidin on Early Rehabilitation After Total Knee Arthroplasty

An observational study in Total Knee Arthroplasty and Venous Insufficiency of Leg, sponsored by Ankara Etlik City Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-07-15.

Sponsored by Ankara Etlik City Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
190
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The goal of this clinical trial is to find out the efficacy of diosmin and hesperidin on postoperative early rehabilitation after primary total knee arthroplasty. The main questions it aims to answer are:

Does diosmin and hesperidin combined drug decreases the lower extremity swelling, pain and increases the range of motion after primary total knee arthroplasty surgery compared to standard therapy group? Does diosmin and hesperidin combined drug decreases inflammation after total knee arthroplasty surgery.

Participants will take diosmin and hesperidin in addition to standard therapy for 14 days after total knee arthroplasty surgery. Lower extremity swelling, pain and range of motion of the patients will be recorded in every visit.

02

Conditions studied

  • Total Knee Arthroplasty
  • Venous Insufficiency of Leg

Keywords

  • Total knee arthroplasty
  • lower extremity swelling
  • inflammation
  • venous insufficiency
  • pain management
03

In context

Inflammation

3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.

This study's enrollment of 190 is above the median of 95 across 895 observational studies indexed under Inflammation.

Browse Inflammation studies →

Lead sponsor

Ankara Etlik City Hospital is the lead sponsor of 166 studies on the registry; 75 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The study included patients who underwent unilateral total knee arthroplasty.

Inclusion criteria

  • Patients who underwent unilateral primary total knee replacement surgery
  • Patients who are functionally ASA 1, ASA 2 or ASA 3.

Exclusion criteria

Exclusion Criteria:

  • Patients >80 years or \<18 years of age
  • Patients with liver insufficiency
  • Patients with allergy to diosmin or hesperidin
  • Patients which are not capable to communicate
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
190 participants (actual)
Target follow-up
14 Days
Patient registry
Yes

Groups and cohorts

  • Study group

    Participants will take diosmin and hesperidin combination in addition to standard therapy for 14 days after total knee replacement surgery.

    Drug: Diosmin and Hesperidin Combination

  • Control group

    Participants will only take standard therapy for 14 days after total knee replacement surgery.

Interventions

  • DrugDiosmin and Hesperidin Combination

    Participants will take diosmin and hesperidin combination for 14 days after total knee replacement surgery.

06

What researchers measure

Primary outcomes

  1. Lower extremity swelling

    Lower extremity swelling is measured by measuring extremity diameters from 3 points (below patella, patella and above patella) and noted. Then percentage of increment or decrement of diameters is measured.

    Time frame: From enrollment to the end of the treatment at 2 weeks

Secondary outcomes

  1. Pain

    The Visual Analog Scale is used to describe patients' pain. It is a scale that describes pain by giving numbers from 0 to 10. 0 means no pain and 10 means extreme pain.

    Time frame: From enrollment to the end of the treatment at 2 weeks

  2. Range of motion

    Knee range of motion is measured with goniometer.

    Time frame: From enrollment to the end of the treatment at 2 weeks

  3. Blood C-reactive protein value as an inflammotory marker

    Time frame: From enrollment to the end of the treatment at 2 weeks

  4. Blood erythrocyte sedimentation rate as an inflammotory marker

    Time frame: From enrollment to the end of the treatment at 2 weeks

  5. Blood neutrophil/lymphocyte rate as an inflammatory marker

    Time frame: From enrollment to the end of the treatment at 2 weeks

  6. Panimmune value (neutrophil x platelet x monocyte / lymphocyte) as an inflammatory marker

    Time frame: From enrollment to the end of the treatment at 2 weeks

  7. The systemic immune-inflammation index (neutrophils × platelets/lymphocytes) as an inflammatory marker

    Time frame: From enrollment to the end of the treatment at 2 weeks

07

Study locations

1 site
  • Ankara Etlik City Hospital
    Ankara, Yenimahalle 06070, Turkey (Türkiye)
08

References and documents

Publications

  • Wang Q, Jin Q, Cai L, Zhao C, Feng P, Jia J, Xu W, Qian Q, Ding Z, Xu J, Gu C, Zhang S, Shi H, Ma H, Deng Y, Zhang T, Song Y, Wang Q, Zhang Y, Zhou X, Pei L, Yang Y, Liang J, Jiang T, Li H, Liu H, Wu L, Kang P. Efficacy of Diosmin in Reducing Lower-Extremity Swelling and Pain After Total Knee Arthroplasty: A Randomized, Controlled Multicenter Trial. J Bone Joint Surg Am. 2024 Mar 20;106(6):492-500. doi: 10.2106/JBJS.23.00854. Epub 2023 Dec 18. PubMed 38109425 ↗
  • Fotiadis E, Kenanidis E, Samoladas E, Chytas A, Lyrtzis C, Koimtzis M, Chalidis B. Are venotonic drugs effective for decreasing acute posttraumatic oedema following ankle sprain? A prospective randomized clinical trial. Arch Orthop Trauma Surg. 2011 Mar;131(3):389-92. doi: 10.1007/s00402-011-1266-9. Epub 2011 Jan 28. PubMed 21274547 ↗
  • Nicolaides AN. The Benefits of Micronized Purified Flavonoid Fraction (MPFF) Throughout the Progression of Chronic Venous Disease. Adv Ther. 2020 Feb;37(Suppl 1):1-5. doi: 10.1007/s12325-019-01218-8. Epub 2020 Jan 22. PubMed 31970659 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06753448
Lead sponsor
Ankara Etlik City Hospital
Responsible party
Ahmet Berkay Girgin (Principal Investigator, Ankara Etlik City Hospital) — Principal investigator
First posted
Dec 31, 2024
Start date
Oct 8, 2024
Primary completion
Jun 10, 2025
Completion
Jun 10, 2025
Last update
Jul 15, 2025

Oversight

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

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion