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

NCT07096037 | Not Yet Recruiting

• 1 other identifier: UDC-OSD-2025
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Osgood-Schlatter Disease

Keywords

Urtica dioica; Osgood-Schlatter disease; KOOS-Child; Visual Analogue Scale

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  measured using the Visual Analog Scale (VAS), a 10-cm line anchored by "no pain" (0) and "worst imaginable pain" (10). VAS scores will be recorded at each clinical visit during the intervention period.

  At each clinical visit during the intervention period (three times a week during 6 weeks).

Secondary Outcomes (2)

• Functional knee status

  Assessments will be done at baseline and after 6 weeks.

• Return to sport

  6 weeks

Other Outcomes (1)

• Adverse events

  At each follow-up visit during 6 weeks

Study Arms (3)

Urtica dioica cataplasm

EXPERIMENTAL

Topical application of Urtica dioica cataplasm

Other: Urtica dioica cataplasm

Standard Care Group

ACTIVE COMPARATOR

Oral vitamin D supplementation and physical rest

Drug: Vitamin D; Behavioral: Resting conditions

Placebo

PLACEBO COMPARATOR

Topical application of a placebo cataplasm

Other: Placebo

Interventions

Urtica dioica cataplasm OTHER

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.

Urtica dioica cataplasm

Placebo OTHER

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.

Placebo

Vitamin D DRUG

Participants will receive oral vitamin D.

Standard Care Group

Resting conditions BEHAVIORAL

Reduction in physical activity based on orthopedic advice.

Standard Care Group

Eligibility Criteria

• Age: 7 Years - 15 Years
• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Faculty of Medicine, Sousse: lead

MeSH Terms

Conditions

Osteochondrosis

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Amira Zairi

  Department of Biochemistry, Faculty of Medicine of Sousse, University of Sousse, Tunisia

  STUDY DIRECTOR

• Sahbi El Mtaoua

  Department of Physical Medicine and Rehabilitation, Hospital Ibn Jazzar of Kairouan, University of Sousse, Tunisia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amira Zairi, Pr.

CONTACT

+21698424285; zairi_amira@yahoo.fr

Hana Nasrallah, PhD

CONTACT

hananasrallah.hn@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: July 31, 2025
• Study Start: September 1, 2025
• Primary Completion: September 15, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share