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

NCT ID: NCT07096037

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Urtica dioica cataplasm

Topical application of Urtica dioica cataplasm

Group Type: EXPERIMENTAL

Urtica dioica cataplasm

Intervention Type: 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.

Standard Care Group

Oral vitamin D supplementation and physical rest

Group Type: ACTIVE_COMPARATOR

Vitamin D

Intervention Type: DRUG

Participants will receive oral vitamin D.

Resting conditions

Intervention Type: BEHAVIORAL

Reduction in physical activity based on orthopedic advice.

Placebo

Topical application of a placebo cataplasm

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Vitamin D

Participants will receive oral vitamin D.

Intervention Type: DRUG

Resting conditions

Reduction in physical activity based on orthopedic advice.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Faculty of Medicine, Sousse

OTHER

Sponsor Role: lead

Responsible Party

Amira Zairi

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amira Zairi

Role: STUDY_DIRECTOR

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

Sahbi El Mtaoua

Role: PRINCIPAL_INVESTIGATOR

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

Central Contacts

Amira Zairi, Pr.

Role: CONTACT

zairi_amira@yahoo.fr

+21698424285

Hana Nasrallah, PhD

Role: CONTACT

hananasrallah.hn@gmail.com

Other Identifiers

UDC-OSD-2025

Identifier Type: -

Identifier Source: org_study_id