Efficacy and tolerability of horse chestnut seed extract on swelling in patients undergoing meniscus surgery: a placebo-controlled, randomized, double-blind, single-center, pilot study

Conditions

pain and edema, post-operative swelling

Brief summary

Volume of the affected knee at visit 5, as determined by optoelectronic measurements, Patient reported outcome measures at visit 5 (co-primary endpoint)

Detailed description

Volume of affected knee at visit 1, visit 2 (before surgery), visit 3 and visit 4, as determined by optoelectronic measurements, Circumference of affected knee as determined by optoelectronic measurements at visit 1, visit 2 (before surgery), visits 3, 4, and 5, Circumference of affected knee as determined by tape at visit 1, visit 2 (before surgery), visits 3, 4 and 5, Range of motion (ROM) of the affected knee joint (Goniometry) at visit 1, visit 2 (before surgery), visits 3, 4 and 5, Skin temperature at surgery site at visit 1, visit 2 (before surgery), visits 3, 4 and 5, Volume of drained fluid after knee surgery at visit 3, PROM at visits 1 - 4, EQ-5D-5L Quality of Life questionnaire [15] at visit 1 and 5, Efficacy of IMP as judged by the Investigator at final visit (end of study), Cumulative usage of analgetic drugs from visit 2 to final visit

Related papers

No related papers found yet.

Interventions

DRUGTablets identical to "Test" in appearance and taste but containing no active ingredient

DRUGAescuven 12

DRUG5 mg überzogene Tablette

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Volume of the affected knee at visit 5, as determined by optoelectronic measurements, Patient reported outcome measures at visit 5 (co-primary endpoint)	—

Secondary

Measure	Time frame
Volume of affected knee at visit 1, visit 2 (before surgery), visit 3 and visit 4, as determined by optoelectronic measurements, Circumference of affected knee as determined by optoelectronic measurements at visit 1, visit 2 (before surgery), visits 3, 4, and 5, Circumference of affected knee as determined by tape at visit 1, visit 2 (before surgery), visits 3, 4 and 5, Range of motion (ROM) of the affected knee joint (Goniometry) at visit 1, visit 2 (before surgery), visits 3, 4 and 5, Skin temperature at surgery site at visit 1, visit 2 (before surgery), visits 3, 4 and 5, Volume of drained fluid after knee surgery at visit 3, PROM at visits 1 - 4, EQ-5D-5L Quality of Life questionnaire [15] at visit 1 and 5, Efficacy of IMP as judged by the Investigator at final visit (end of study), Cumulative usage of analgetic drugs from visit 2 to final visit	—

Measure

Time frame

Volume of affected knee at visit 1, visit 2 (before surgery), visit 3 and visit 4, as determined by optoelectronic measurements, Circumference of affected knee as determined by optoelectronic measurements at visit 1, visit 2 (before surgery), visits 3, 4, and 5, Circumference of affected knee as determined by tape at visit 1, visit 2 (before surgery), visits 3, 4 and 5, Range of motion (ROM) of the affected knee joint (Goniometry) at visit 1, visit 2 (before surgery), visits 3, 4 and 5, Skin temperature at surgery site at visit 1, visit 2 (before surgery), visits 3, 4 and 5, Volume of drained fluid after knee surgery at visit 3, PROM at visits 1 - 4, EQ-5D-5L Quality of Life questionnaire [15] at visit 1 and 5, Efficacy of IMP as judged by the Investigator at final visit (end of study), Cumulative usage of analgetic drugs from visit 2 to final visit

—

Countries

Germany

Outcome results

None listed