tolerability and efficacy of Lymdiaral Injektopas (Pascoe-Named)
Conditions
Interventions
Product Name: LYMDIARAL INJEKTOPAS
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CONIUM MACULATUM, HYDRASTIS CANADENSIS, PHYTOLACCA, URGINEA MARITTIMA, VISCUM ALBUM
Concentration un
Sponsors
NAMED SRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Age> 18 years -Suffering from IVLC connected to PEFS 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Will be excluded from the study subjects who also have one of the following signs or symptoms or conditions: - Secondary Edema to other diseases (disendocrinopatie, kidney disease, liver disease, connective, heart disease). - Patients suffering from incontinence of hemodynamic precludes saphenous-femoral - Pharmacological treatments in progress that may change the evaluation of results (corticosteroids, estrogen-progestine, Ca-antagonists phlebotonic, diuretics). - History pathological autoimmune disorders, neoplastic and paraneoplastic syndromes. - History pathological positive for allergy to medications in general. - Hypersensitivity to one or more components of the product concerned and the composite. -Pharmacological treatments in progress that may change the evaluation of results (corticosteroids, estrogen-progestine, Ca-antagonists, phlebotonic, diuretics) - In Combination with other methods for the same pathology. - Pregnancy - Breastfeeding - In diet therapy treatment - Participation in other clinical studies during the previous six months - Conditions that in the opinion of the physician evaluator, interfere with the ongoing study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the tolerability of Lymdiaral injektopas (Pascoe-Named) in patients administered with technical IVLC PEFS and ITD;Secondary Objective: Evaluate the efficacy of Lymdiaral injektopas (Pascoe-Named) in patients administered with technical IVLC PEFS and ITD;Primary end point(s): Tolerability of the product Lymdiaral Injektopas(Pascoe-Named) | — |
Countries
Italy
Outcome results
None listed