Rhodiola rosea Extract WS® 1375 in subjects with chronic fatigue symptoms
| ISRCTN | ISRCTN70529301 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70529301 |
| Secondary identifying numbers | 578001.01.011 |
- Submission date
- 07/02/2012
- Registration date
- 12/03/2012
- Last edited
- 08/08/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
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
Contact information
Dr Igor Tartakovsky
Scientific
Scientific
Dr. Willmar Schwabe GmbH & Co. KG
Willmar-Schwabe-Str. 4
Karlsruhe
76227
Germany
Study information
| Study design | Open multicentre single-arm phase III study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Other |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Rhodiola rosea Extract WS® 1375 in subjects with chronic fatigue symptoms |
| Study objectives | 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(s) | Central Ethics Committee, Ministry of Health Ukraine, 05/07/2011, ref: 5.12-753/KE dtd |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 15/12/2011 |
| Completion date | 31/08/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 patients |
| Key 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). |
| Key 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) |
| Date of first enrolment | 15/12/2011 |
| Date of final enrolment | 31/08/2012 |
Locations
Countries of recruitment
- Germany
- Ukraine
Study participating centre
Dr. Willmar Schwabe GmbH & Co. KG
Karlsruhe
76227
Germany
76227
Germany
Sponsor information
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Research organisation
Research organisation
Willmar-Schwabe-Str. 4
Karlsruhe
76227
Germany
| Website | http://www.schwabepharma.com/ |
|---|---|
"ROR" |
https://ror.org/043rrkc78 |
Funders
Funder type
Research organisation
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
