EUCTR2008-002134-29-GB进行中（未招募）不适用
Rhodiola rosea Extract WS® 1375 in Subjects with Life Stress Symptoms
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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).
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