ISRCTN70529301已完成不适用
Rhodiola rosea Extract WS® 1375 in subjects with chronic fatigue symptoms
Dr. Willmar Schwabe GmbH & Co. KG (Germany)0 个研究点目标入组 100 人开始时间: 2012年3月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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).
排除标准
- •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)
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