Clinical trial to evaluate the efficacy and safety of Solanum malacoxylon 9CH in patients with calcific tendinitis of shoulder

Pilot phase II clinical trial, randomized, double-blind, controlled, single-center study to evaluate the efficacy and safety of Solanum malacoxylon 9CH in patients with calcific tendinitis of shoulder

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003238-29-ES

Enrollment

104

Registered

2015-12-18

Start date

2016-04-06

Completion date

Unknown

Last updated

2018-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Calcific tendinitis of shoulder

Interventions

Trade Name: Solanum malacoxylon 9CH Pharmaceutical Form: Granules Pharmaceutical form of the placebo: Granules Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? 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

Exclusion criteria

Exclusion criteria: ? 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Solanum malacoxylon 9CH efficacy;Secondary Objective: Determine clinical improvement, measured in terms of improvement in pain, function and mobility. Assess patient satisfaction Compare the use of NSAIDs 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

Measure	Time frame
Secondary end point(s): Cinical improvement Satisfaction with treatment Consumption of NSAIDs;Timepoint(s) of evaluation of this end point: End of treatment	—

Countries

Spain

Contacts

Public ContactDepartamento de Ensayos Clínicos

Dynamic

a.perez@dynasolutions.com003491456 1105

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026