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Not yet recruitingNCT07096037Updated Aug 1, 2025

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

An interventional study of Urtica dioica cataplasm and Placebo in Osgood-Schlatter Disease, sponsored by Faculty of Medicine, Sousse. Not yet recruiting. Open to male participants aged 7 Years to 15 Years. Per ClinicalTrials.gov, last updated 2025-08-01.

Sponsored by Faculty of Medicine, Sousse · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 1 month ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
7 Years to 15 Years
Sex
Male
01

Study 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
02

Conditions studied

  • Osgood-Schlatter Disease

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Keywords

  • Urtica dioica
  • Osgood-Schlatter disease
  • KOOS-Child
  • Visual Analogue Scale
03

In context

Osteochondrosis

16 studies on the registry are indexed under Osteochondrosis; 5 are open to participants now.

This study's planned enrollment of 90 is above the median of 51 across 13 interventional studies indexed under Osteochondrosis.

Browse Osteochondrosis studies →

Lead sponsor

Faculty of Medicine, Sousse is the lead sponsor of 23 studies on the registry; 6 are open to participants now.

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

04

Who can participate

Ages eligible
7 Years to 15 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Urtica dioica cataplasm

    Topical application of Urtica dioica cataplasm

    Other: Urtica dioica cataplasm

  • Active comparator
    Standard Care Group

    Oral vitamin D supplementation and physical rest

    Drug: Vitamin D · Behavioral: Resting conditions

  • Placebo comparator
    Placebo

    Topical application of a placebo cataplasm

    Other: Placebo

Interventions

  • OtherUrtica 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.

  • OtherPlacebo

    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.

  • Participants will receive oral vitamin D.

  • BehavioralResting conditions

    Reduction in physical activity based on orthopedic advice.

06

What researchers measure

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.

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

Secondary outcomes

  1. Functional knee status

    assessed using the KOOS-Child questionnaire, covering five subscales (pain, symptoms, activities of daily living, sport/recreation function, and knee-related quality of life). Scores range from 0 (extreme dysfunction) to 100 (no symptoms).

    Time frame: Assessments will be done at baseline and after 6 weeks.

  2. Return to sport

    defined as the number of days post-treatment needed to resume regular athletic activity.

    Time frame: 6 weeks

Other outcomes

  1. Adverse events

    Adverse events (skin reactions, discomfort, or other clinical complaints) will be recorded systematically.

    Time frame: At each follow-up visit during 6 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2025; primary completion for Sep 2025, 0 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 24, 2025
First posted
Jul 31, 2025
StartEst.
Sep 1, 2025
Primary completionEst.
Sep 15, 2025
CompletionEst.
Sep 30, 2026
Last update
Aug 1, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07096037
Lead sponsor
Faculty of Medicine, Sousse
Responsible party
Amira Zairi (Professor, Faculty of Medicine, Sousse) — Principal investigator
First posted
Jul 31, 2025
Start date
Sep 1, 2025 (estimated)
Primary completion
Sep 15, 2025 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Aug 1, 2025

Study contacts

Amira Zairi, Pr.
Contact
zairi_amira@yahoo.fr
+21698424285
Hana Nasrallah, PhD
Contact
hananasrallah.hn@gmail.com
Amira Zairi
study director · Department of Biochemistry, Faculty of Medicine of Sousse, University of Sousse, Tunisia
Sahbi El Mtaoua
principal investigator · Department of Physical Medicine and Rehabilitation, Hospital Ibn Jazzar of Kairouan, University of Sousse, Tunisia

Oversight

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

Not currently enrolling

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

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