Rhodiola rosea Extract WS® 1375 in Subjects with Life Stress Symptoms

• Research type

  Research Study

• Full title

  A study to investigate the therapy effects, safety and tolerability of Rhodiola rosea Extract WS® 1375 in subjects with Life Stress Symptoms

• IRAS ID

  8970

• Sponsor organisation

  Dr. Willmar Schwabe GmbH & Co. KG

• Eudract number

  2008-002134-29

• ISRCTN Number

  n/a

• Research summary

  This study is an open,multicentre, single arm study in subjects with Life Stress Symptomatic who willbe assigned for Rhodiola rosea Extract WS© 1375 treatment. Rhodiola rosea L. isa plant that grows at high altitudes in the arctic areas of Europe, Asia and North America. It is a traditional herbal medicinalproduct registered in the UKfor the treatment of mental and physical symptoms of stress and overwork, suchas fatigue, exhaustion and mild anxiety. Since these symptoms are having anegative flunce on the patients' quality of life, it is important to providethem with a well tolerated therapy. The study will be conducted by general practitionersin the UK.Patients with Life Stress Symptoms will be screened and enrolled in a singletreatment group and will be treated for a period of 4 weeks, during which They'll see their study physcian four times. The treatment effects will be measuredaccording to changes in life stress symptoms.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  08/H0605/146

• Date of REC Opinion

  18 Nov 2008

• REC opinion

  Favourable Opinion