Rhodiola rosea Extract WS® 1375 in subjects with chronic fatigue symptoms

Completed

Conditions: Chronic fatigue symptoms
Signs and Symptoms
Chronic fatigue

Registration Number: ISRCTN70529301

Lead Sponsor: Dr. Willmar Schwabe GmbH & Co. KG (Germany)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 100

Inclusion Criteria

1. Male or female outpatients aged 18 to 60 years (both inclusive)
2. Signed Informed consent in accordance with the legal requirements
3. Clinically evaluated, unexplained persistent or relapsing fatigue symptoms lasted at least 2 months that:
3.1. Is not the result of ongoing exertion
3.2. Is not substantially relieved by rest
3.3. Results in substantial reduction in previous levels of occupational, educational, social or personal activities
4. The following perceived Chronic Fatigue Symptoms listed below assessed as =5 on NASs:
4.1. Postexertional malaise (extreme prolonged exhaustion following physical or mental exertion) lasting more than 24 hours
4.2. Substantial impairment in short-time memory and concentration
4.3. Unrefreshing sleep
5. Multidimensional Fatigue Inventory 20 (MFI-20) score 7 or more for the sub-scales:
5.1. General fatigue
5.2. Physical fatigue
5.3. Mental fatigue
6. 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.
7. Negative pregnancy test at Screening visit in females of childbearing potential (non-childbearing potential is defined as post-menopause for at least one year or surgical sterilization or hysterectomy at least three months before study start).

Exclusion Criteria

1. 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. Beck?s Depression Inventory (BDI-II) item 9 = 1
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 according to DSM-IV at least one year before enrolment - the last episode must have been finished at least one year before enrolment. (Common Axis I disorders include major depression, anxiety disorders, bipolar disorder, ADHD, autism spectrum disorders, phobias, and schizophrenia. Major Depression is defined by BDI-II total score >19 at Screening.)
6. Non-medical psychiatric treatment (e.g., specific standardized psychotherapy) at least 4 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:
7.1. 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
7.2. Long-term prophylactic treatment (e.g. lithium, carbamazepine)
7.3. Treatments for neuro-degenerative diseases
7.4. Central-acting antihypertensive medication (e.g. reserpine, clonidin, methyldopa), antihypertensive medication with guanethidine, guanoxan, prazosine
7.5. Beta-blockers (exception: stable dosage for at least 4 weeks)
7.6. Antiparkinson medication
7.7. Muscle relaxants
7.8. Analgetics of opiate type
7.9. Anesthetics
8. Clinical significant abnormality of ECG and/or laboratory value(s).
9. Any clinically relevant:
9.1. Hepatic, renal disorders (serum creatinine or serum ASAT, ALAT or Gamma GT above 3 times the upper limit of the reference range)
9.2. Cardiovascular diseases
9.3. Respiratory diseases
9.4. Metabolic disorder or progressive diseases as cancer (exception: prostate cancer T1N0M0 which does not require treatment within the next 7 months except hormone therapy)
9.5. Haematologic diseases
9.6. Cerebrovascular and neurologic diseases (epilepsy or a history of seizure disorder or treatment with anticonvulsants for epilepsy or seizures, Parkinson?s disease, multiple sclerosis, injury with residual neurologic deficits)
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, oral or injectable contraception)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment effect outcome variables:<br>1. Multidimensional Fatigue Inventory 20 (MFI-20)<br>2. Three NASs of Chronic Fatigue Symptoms<br>3. Pittsburgh Sleep Quality Index (PSQI)<br>4. Numbers Connecting Test<br>5. Sheehan Disability Scale<br>6. Recent Perceived Stress Questionnaire (R-PS Qustionnaire)<br>7. Beck?s Depression Inventory (BDI-II)<br>8. Clinical Global Impressions (CGI)<br><br>Safety outcome variables:<br>1. Physical examination<br>2. Vital signs<br>3. Adverse events<br>4. Laboratory tests

Secondary Outcome Measures