Plain English Summary
Background and study aims
Clinical studies and experiments with Rhodiola rosea extract have demonstrated significant relief of stress, fatigue and exhaustion. The aim of this study is to obtain information about the effects and safety of Rhodiola rosea extract in subjects with chronic fatigue symptoms.
Who can participate?
Male or female outpatients aged 18 to 60 years with clinically evaluated, unexplained persistent or relapsing fatigue symptoms lasting for at least 2 months.
What does the study involve?
Participants will undergo a physical examination, electrocardiogram (ECG) and laboratory tests including blood sampling at the beginning and the end of the trial. All participants will be treated with Rhodiola rosea extract. We will measure the effects of treatment on fatigue, sleep, concentration and level of activity.
What are the possible benefits and risks of participating?
Published clinical studies reported no adverse events for participants under active treatment related to Rhodiola rosea extract.
Where is the study run from?
The study is running in 10 sites/university based clinics in Ukraine.
When is the study starting and how long is it expected to run for?
The study ran from December 2011 to August 2012.
Who is funding the study?
Dr. Willmar Schwabe GmbH & Co. KG (Germany).
Who is the main contact?
Mrs Anna Wacker
anna.wacker@schwabe.de
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
578001.01.011
Study information
Scientific title
Rhodiola rosea Extract WS® 1375 in subjects with chronic fatigue symptoms
Acronym
Study hypothesis
The objective of this clinical trial is to describe therapy effects, safety and tolerability of Rhodiola rosea Extract WS® 1375 in subjects with chronic fatigue symptoms.
Ethics approval
Central Ethics Committee, Ministry of Health Ukraine, 05/07/2011, ref: 5.12-753/KE dtd
Study design
Open multicentre single-arm phase III study
Primary study design
Interventional
Secondary study design
Other
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Chronic fatigue symptoms
Intervention
2 x 200 mg Rhodiola rosea Extract WS® 1375
The following self-rating scales and questionnaires will be used in this trial:
1. Multidimensional Fatigue Inventory 20 (MFI-20) assessment of the chronic fatigue symptoms
2. Three Numerical Analogue Scales of chronic fatigue symptoms (postexertional malaise, impaired memory and concentration; unrefreshing sleep)
3. Sheehan Disability Scale assessment of the impairment of daily living and reduction in previous levels of activity
4. Number Connecting Test assessment of memory and concentration
5. Pittsburgh Sleep Quality Index (PSQI) assessment of sleep quality
6. Recent Perceived Stress Questionnaire (PSQ-R) assessment of stress level
7. Becks Depression Inventory (BDI-II) assessment of depression
8. Clinical Global Impression (CGI) - physician rated, for changes from baseline as well as as for the assessment of the tolerability
The completion of the patient self-rating scales, including the NCT test with the stop watch will take estimated between 40 and 60 minutes per study visit. Not for all visits all test are required, in this case the estimated time for the completion of the questionnaires will be shorter, about 30 minutes.
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measures
Treatment effect outcome variables:
1. Multidimensional Fatigue Inventory 20 (MFI-20)
2. Three NASs of Chronic Fatigue Symptoms
3. Pittsburgh Sleep Quality Index (PSQI)
4. Numbers Connecting Test
5. Sheehan Disability Scale
6. Recent Perceived Stress Questionnaire (R-PS Qustionnaire)
7. Becks Depression Inventory (BDI-II)
8. Clinical Global Impressions (CGI)
Safety outcome variables:
1. Physical examination
2. Vital signs
3. Adverse events
4. Laboratory tests
Secondary outcome measures
No secondary outcome measures
Overall trial start date
15/12/2011
Overall trial end date
31/08/2012
Reason abandoned
Eligibility
Participant 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 physicians 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).
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100 patients
Participant 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. Becks 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, Parkinsons 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)
Recruitment start date
15/12/2011
Recruitment end date
31/08/2012
Locations
Countries of recruitment
Ukraine
Trial participating centre
Dr. Willmar Schwabe GmbH & Co. KG
Karlsruhe
76227
Germany
Sponsor information
Organisation
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Sponsor details
Willmar-Schwabe-Str. 4
Karlsruhe
76227
Germany
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary