Clinical trial to evaluate the efficacy and safety of Solanum malacoxylon 9CH in patients with calcific tendinitis of shoulder
- Conditions
- Calcific tendinitis of shoulderTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2015-003238-29-ES
- Lead Sponsor
- Fundación Sociedad Española de Médicos de Atención Primaria (SEMERGEN)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 104
? Patients who have given written informed consent.
? Patients of both sex with age ? 18 years in the screening visit.
? Diagnosis of calcifying tendinitis of shoulder confirmed by image (standard radiography [Rx] and / or ultrasound in the 3 months prior to study treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 104
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 104
? Women pregnant or nursing.
? Patients receiving homeopathic treatment.
? Patients candidates for scheduled within 2 months following surgery.
? Patients who have been treated with corticosteroids (oral or infiltrate) or invasive procedure (shock waves, ultrasound, etc.) in the past 3 months.
? Patients who are unwilling or unable to comply with the protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Solanum malacoxylon 9CH efficacy;Secondary Objective: Determine clinical improvement, measured in terms of improvement in pain, function and mobility.<br>Assess patient satisfaction<br>Compare the use of NSAIDs<br>Determine the safety profile;Primary end point(s): Change in lesion area measured by ultrasonography;Timepoint(s) of evaluation of this end point: End of treatment
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Cinical improvement<br>Satisfaction with treatment<br>Consumption of NSAIDs;Timepoint(s) of evaluation of this end point: End of treatment