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

Conditions: subjects with life stress symptoms

Registration Number: EUCTR2008-002134-29-GB

Lead Sponsor: Dr. Willmar Schwabe GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

1.Male or female outpatients aged 30 to 60 years (both inclusive).
2.Signed Informed consent in accordance with the legal requirements.
3.At least 3 of perceived Life Stress Symptoms listed below assessed as =5 on NASs:
1)Somatic symptoms: gastrointestinal or cardio-vascular disturbances, muscle tension or backache, frequent headaches,
2)Loss of Zest for life
3)Exhaustion
4)Irritability ( Exploding easily at seemingly inconsequential things)
5)Impairment of concentration
6)Feelings of heteronomy (i.e. feeling of being controlled by somebody/something, e.g. by another person or by emotions/situations)
7) Anxiety
4.Multidimensional Fatigue Inventory 20 (MFI-20) score 7 or more at least for one sub-scale.
5.Sufficient language skills, readiness, and ability on the part of the patient to comply with the physician’s instructions, respond to all interview questions, and to fill in the self-assessment scales without evident difficulties and without the assistance of an interpreter.

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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Participation in another experimental drug trial at the same time or within the past 12 weeks before enrolment.
2.Current hospitalization of the patient.
3. Risk of suicide.
4. History or evidence of alcohol and/or substance abuse or dependence, particularly of
sedatives, hypnotics and anxiolytics within the last 5 years.
5. History of Axis I disorders at least one year before enrolment.
6. Non-medical psychiatric treatment (e.g., specific standardized psychotherapy) at least4 weeks before the study.
7. Unacceptability to discontinue or likelihood to need medication during the study that is prohibited as concomitant treatment (specified in section 6). The following medication is not allowed during the study:
•any psychotropic drugs including CNS stimulants, tranquilizers / hypnotics (e.g. benzodiazepines, non-benzodiazepines like zopiclone or zolpidem, barbiturates), neuroleptics / antipsychotics, antidepressives, antiepileptics, antihistaminics, anti-emetics and nootropics
•long-term prophylactic treatment (e.g. lithium, carbamazepine)
•treatments for neuro-degenerative diseases
•central-acting antihypertensive medication (e.g. reserpine, clonidin, ?-methyldopa), antihypertensive medication with guanethidine, guanoxan, prazosine
•beta-blockers (exception: stable dosage for at least 4 weeks)
•antiparkinson medication
•anxiolytics including phyto-anxiolytics
•muscle relaxants
•analgetics of opiate type
•anesthetics.
8. Clinical significant abnormality of ECG and/or laboratory value(s).
9. Any clinically relevant hepatic, renal (serum creatinine or serum ASAT, ALAT or Gamma GT above 3 times the upper limit of the reference range), cardiovascular, respiratory, cerebrovascular, metabolic disorder or progressive diseases as cancer (exception: prostate cancer T1N0M0 which does not require treatment within the next 7 months except hormone therapy), haematologic diseases or thyroid insufficiency, epilepsy or a history of seizure disorder or treatment with anticonvulsants for epilepsy or seizures, Parkinson’s disease.
10. Any form of diabetes mellitus.
11. Clinically significant anaemia.
12. Clinically significant thyroid dysfunction as expressed by significant abnormality in TSH,
T3 and/or T4 levels.
13. Any acute or chronic form of infection including HIV infection or Lues of any stage (according to medical history or clinical signs and symptoms).
14. Known hypersensitivity to Rhodiola rosea extract.
15. Gastrointestinal disorders with uncertain absorption of orally administered drugs (e.g. partial or total gastrectomy, enterectomy, inflammatory bowel disease, celiac disease, symptomatic lactose intolerance, other disorders associated with chronic diarrhoea).
16.Pregnancy, lactation.
17.Patients capable of childbearing if not using adequate contraception (intra-uterine devices or injectable contraception).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this clinical trial is to describe therapy effects, safety and tolerability of Rhodiola rosea Extract WS® 1375 in subjects with Life Stress Symptoms. ;Secondary Objective: ;Primary end point(s): Treatment effect outcome variables:<br>•7 NASs of Subjective Stress Symptoms<br>•Perceived Stress Questionnaire (PSQ)<br>•Multidementional Fatigue Inventory 20 (MFI-20)<br>•Numbers Connecting Test<br>•Sheehan Disability Scale<br>•Multidimensional Mood State Questionaire (MDMQ)<br>•Clinical Global Impressions (CGI)<br><br>Safety outcome variables:<br>•Physical Examination<br>•Vital Signs<br>•Adverse Events<br>•Laboratory Tests<br>

Secondary Outcome Measures