Placebo-controlled exploratory pilot study to investigate the effect and onset of action of Traumaplant® for delayed onset muscle soreness.

Cassella-med GmbH & Co. KG0 个研究点开始时间: 2011年11月29日最近更新: 2013年2月4日

试验速览

暂无简介。

•- 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

•- 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

发起方