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Not yet recruiting NCT07096037

Safety and Efficacy of Urtica Dioica Cataplasm in the Management of Osgood-Schlatter Disease in Young Athletes

No phase Interventional Osgood-Schlatter Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Urtica dioica cataplasm, Placebo, Vitamin D, Resting conditions.
Who it may be relevant to
Registry conditions: Osgood-Schlatter Disease. Basic parameters: 7 years — 15 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluation of Safety and Efficacy of Urtica Dioica Cataplasm in the Management of Osgood-Schlatter Disease in Young Athletes: A Study Protocol for Randomized, Double-blind, Placebo Controlled Clinical Trial

Overview

The primary objective of this clinical trial is to evaluate the efficacy and safety of a topical Urtica dioica cataplasm in managing knee pain and functional limitations in athletic children diagnosed with Osgood-Schlatter Disease. Efficacy will be assessed through changes in knee pain using the Visual Analog Scale (VAS) and functional outcomes using the Knee Injury and Osteoarthritis Outcome Score (KOOS). Three groups will be tested: * UDC Group: topical application of Urtica dioica cataplasm * Standard Care Group: oral vitamin D supplementation and physical rest * Placebo Group: topical application of a placebo cataplasm using Beta vulgaris subsp. cicla

Interventions

  • Other Urtica dioica cataplasm
    Participants will receive a warm Urtica dioica cataplasm applied topically on the affected knee, once daily for 60 minutes, three times per week (on alternate days) over a 6-week period.
  • Other Placebo
    Participants will receive a placebo cataplasm, matched in texture, color, and odor to the active treatment. The placebo is inert and safe for pediatric topical use.
  • Drug Vitamin D
    Participants will receive oral vitamin D.
  • Behavioral Resting conditions
    Reduction in physical activity based on orthopedic advice.

Primary outcome measures

  • Pain intensity [Time frame: At each clinical visit during the intervention period (three times a week during 6 weeks).]
Secondary outcome measures (2)
  • Functional knee status [Time frame: Assessments will be done at baseline and after 6 weeks.]
  • Return to sport [Time frame: 6 weeks]

Eligibility criteria

Inclusion criteria

  • Healthy male children between 7 and 15 years of age
  • Active in regular sports practice (e.g., football)
  • Clinically confirmed diagnosis of OSD

Exclusion criteria

  • Known allergy to Urtica dioica
  • Presence of dermatological conditions or lesions on the knees
  • Recent use of anti-inflammatory medications
  • History of immune or chronic inflammatory diseases
  • Diagnosis of any other bone disorder

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07096037 · UDC-OSD-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗