Randomized, Double-blind, Placebo Controlled Clinical Study To Evaluate Analgesic Efficacy of Topically Administered Traditional Herbal Medicinal Product for Relief of Acute Muscular Pain.

INTERVENTION: Trade Name: Rosacta krema Product Name: Rosacta krema Pharmaceutical Form: Cream Pharmaceutical form of the placebo: Cream Route of administration of the placebo: Cutaneous use CONDITION: Acute Muscular Pain Therapeutic area: Not possible to specify PRIMARY OUTCOME: Main Objective: The proportion of subjects with clinically significant decrease in pain intensity (?NRS = 2 points) after 7 days in a test group in comparison to the group receiving placebo. Primary end point(s): The proportion of subjects with clinically significant decrease in pain intensity (?NRS = 2 points) after 7 days in the test group compared to the group receiving placebo. Secondary Objective: n.a. Timepoint(s) of evaluation of this end point: After 7 days of treatment SECONDARY OUTCOME: Secondary end point(s): • The proportion of subjects with clinically significant decrease in pain intensity (?NRS = 2 points) after 4 days in a test group in comparison to the group receiving placebo.; • Decrease in pain intensity (NRS) after 7 days from baseline in a test group in comparison to the group receiving placebo.; • Decrease in pain intensity (NRS) after 4 days from baseline in a test group in comparison to the group receiving placebo.; • The proportion of subjects with the decrease in pain intensity for 33% of NRS points after 7 days in a test group in comparison to the group receiving placebo.; • The proportion of subjects with the decrease in pain intensity for 33% of NRS points after 4 days in a test group in comparison to the group receiving placebo.; • The amount of intake of rescue medication in a test group in comparison to the group receiving placebo, for 7 days of the study duration. ; • The incidence of adverse events in a test group in comparison to the group receiving placebo, for 7 days of the study duration.; • The incidence of serious adverse events in a test group in comparison to the group receiving placebo, for 7 days of the study duration; • Quality of Life improvement (SF‐36v2 with PIQ‐6, acute recall); Timepoint(s) of evaluation of this end point: The proportion of subjects with clinically significant decrease in pain intensity (?NRS = 2 points), Decrease in pain intensity, The proportion of subjects with decrease in pain intensity for 33% of NRS, ‐ will be evaluated after 4 days of treatment; ; Decrease in pain intensity, The proportion of subjects with decrease in pain intensity for 33% of NRS, amount of intake of rescue medication, incidence of adverse events, incidence of serious adverse events, Quality of Life improvement ‐ will be evaluated after 7 days of treatment INCLUSION CRITERIA: • Male and female • 30‐65 years • Acute muscular pain • Pain strength 4‐6 according to NRS 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 148 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range