Osgood-Schlatter DiseaseNCT07096037
Safety and Efficacy of Urtica Dioica Cataplasm in the Management of Osgood-Schlatter Disease in Young Athletes
A study testing Urtica dioica cataplasm, Vitamin D and Resting conditions in people with Osgood-Schlatter Disease, run by Faculty of Medicine, Sousse.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 15 years, men only
- Conditions the study is for
- Osgood-Schlatter Disease
- What is being tested?
- Urtica dioica cataplasm, Vitamin D and Resting conditions
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 15 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Healthy male children between 7 and 15 years of age
- Active in regular sports practice (e.g., football)
- Clinically confirmed diagnosis of OSD
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Hana Nasrallah, PhD contact
About this study
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
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
- Being tested
- Urtica dioica cataplasm, Placebo, Vitamin D, Resting conditions
- Keywords
- Urtica dioica, Osgood-Schlatter disease, KOOS-Child, Visual Analogue Scale
- Medical subject headings
- Osteochondrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urtica dioica cataplasmOther
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.
PlaceboOther
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.
Vitamin DDrug
Participants will receive oral vitamin D.
Resting conditionsBehavioural
Reduction in physical activity based on orthopedic advice.
| Study group | Role | What they receive |
|---|---|---|
| Urtica dioica cataplasm | Experimental | Topical application of Urtica dioica cataplasm Receives: Other: Urtica dioica cataplasm |
| Standard Care Group | Active comparator | Oral vitamin D supplementation and physical rest Receives: Drug: Vitamin D; Behavioral: Resting conditions |
| Placebo | Placebo comparator | Topical application of a placebo cataplasm Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At each clinical visit during the intervention period (three times a week during 6 weeks).
Secondary outcomes (2)
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).
Measured: Assessments will be done at baseline and after 6 weeks.
Return to sport
defined as the number of days post-treatment needed to resume regular athletic activity.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion15 Sep 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osgood-Schlatter DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculty of Medicine, Sousse
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Zairi, Faculty of Medicine, Sousse
- Investigators
- Amira Zairi, Study director, Department of Biochemistry, Faculty of Medicine of Sousse, University of Sousse, TunisiaSahbi El Mtaoua, Principal investigator, Department of Physical Medicine and Rehabilitation, Hospital Ibn Jazzar of Kairouan, University of Sousse, Tunisia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096037
- Sponsor's protocol ID
- UDC-OSD-2025
- Status last verified
- Jul 2025
- First submitted
- 24 Jul 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07096037
- Acronym / sponsor ID
- UDC-OSD-2025
- Conditions
- Osgood-Schlatter Disease
- Keywords
- Urtica dioica, Osgood-Schlatter disease, KOOS-Child, Visual Analogue Scale
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Faculty of Medicine, SousseUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Urtica dioica cataplasm | Experimental | Other: Urtica dioica cataplasmTopical application of Urtica dioica cataplasm |
| Standard Care Group | Active comparator | Drug: Vitamin D, Behavioral: Resting conditionsOral vitamin D supplementation and physical rest |
| Placebo | Placebo comparator | Other: PlaceboTopical application of a placebo cataplasm |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy male children between 7 and 15 years of age
- Active in regular sports practice (e.g., football)
- Clinically confirmed diagnosis of OSD
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urtica dioica cataplasmParticipants 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 | Urtica dioica cataplasm |
| PlaceboParticipants 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. | Other | Placebo |
| Vitamin DParticipants will receive oral vitamin D. | Drug | Standard Care Group |
| Resting conditionsReduction in physical activity based on orthopedic advice. | Behavioural | Standard Care Group |
Primary outcome
Pain intensity
Time frame: At each clinical visit during the intervention period (three times a week during 6 weeks).
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.
2 secondary outcomes
Functional knee status
Time frame: Assessments will be done at baseline and after 6 weeks.
Return to sport
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hana Nasrallah, PhD contact
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
Questions about this trial
What is this clinical trial studying?
A study testing Urtica dioica cataplasm, Vitamin D and Resting conditions in people with Osgood-Schlatter Disease, run by Faculty of Medicine, Sousse.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amira Zairi, Pr. (+21698424285, zairi_amira@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: At each clinical visit during the intervention period (three times a week during 6 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.