delayed onset muscle soreness (DOMS) MedDRA version: 14.1 Level: LLT Classification code 10028332 Term: Muscle soreness System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: Traumaplant
Pharmaceutical Form: Cream
INN or Proposed INN: Symphytum x uplandicum NYMAN
CAS Number: 8000040-21-3
Other descriptive name: SYMPHYTUM OFFICINALE
Concentration unit: g gram(s)
Sponsors
Cassella-med GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - male and female subjects, aged 18-45 years - written informed consent of the subjects - sufficiently physical capacity - muscle pain (DOMS) in biceps brachii muscles (bilateral) after exercise within 48 hours - body mass index of less than or equal 30 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 24 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - disorders or injuries of the skeletal musculature and the connective and supporting tissue (arms, shoulder belt, back) - neurological disorders - skin diseases (e.g. neurodermitis, psoriasis) - arterial hypertension - any diseases or conditions, that affect adversely the risk-benefit ratio from investigator´s point of view or affect the study conduct (e.g. cardiovascular diseases, diseases of the lung, skin diseases) - regular training of arm and shoulder muscles - topical application and/or oral administration of pain-relieving medications (for a period of 2 days before visit 1 and during the trial) - any local therapy in the entire upper body area, e.g. thermotherapy or massage during the trial - known sensitivity to the ingredients of the IMP - Pregnancy or breast-feeding. Premenopausal women must use an approved birth control method - any current diagnosis of alcohol or substance abuse/dependence (with the exception of cigarette smoking) - simultaneous participation in another clinical trial or participation in a clinical trial during 6 weeks before start of this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the difference between one-time topical application of verum and placebo regarding the effect and the onset of action in treating DOMS of the biceps brachii muscle.Variable for it is the change of PPT, measured before and after the muscular exercise of the upper arm musculature (v1 and v2) as well as several times within 4 hours after application of verum and placebo (visit2) determined by using an electronic pressure algometer.Further the movement pain in the upper arms of the subjects (VAS) to the times indicated above as well as the pain-free mobility in the elbow joints are determined and evaluated in the group comparison. Global evaluation of the clinical effect and tolerability as well as the occurrence of adverse events are documented and evaluated. The exploratory approach is chosen because there are no previously literature data concerning the effect of the investigational product in DOMS. It is an initial collection of basic data for the generation of specific issues.;Secondary Objective: all objectives are main objectives;Primary end point(s): comparison of verum and placebo: change (baseline vs. end of trial) in pressure pain threshold, movement pain in the upper arms of the subjects (VAS) and pain-free mobility in the elbow joints;Timepoint(s) of evaluation of this end point: Baseline after the muscular exercise of the upper arm musculature (visit 2) and during 4 hours after application of verum and placebo (visit 2) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): All end points are primary end points;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Germany
Contacts
Public ContactMedical Science Division
Cassella-med GmbH & Co. KG
Outcome results
None listed