NCT02865863已完成2 期
Safety and Efficacy Profile of the Eurycomalongifoliawaterextract (Physta®)+Multivitamin Study Product
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 86
- 主要终点
- The change in quality of life after 24 weeks of supplementation with study product, measured using the SF-12 Quality of Life Questionnaire
研究概览
简要总结
A phase II randomized, placebo controlled study evaluating the efficacy of Eurycomalongifoliawater extract (Physta®)+Multivitamin on quality of life and mood on 86 healthy adults over a 24 week supplementation period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects ≥ 25 and ≤ 65 years of age.
- •Body mass index (BMI) ≥ 18 and ≤30 kg/m
- •Subjects must be employed in a job/position that has some degree of responsibility such that they experience a mid-level of stress at work.
- •Subjects with a score of ≤ 18 in the Tension subscale and a score of ≤ 14 in the Fatigue subscale of the POMS Questionnaire.
- •Judged by the Investigator to be in general good health on the basis of medical history.
- •Females of child-bearing potential must agree to use appropriate birth control methods during the study.
- •Understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator
- •Understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator
排除标准
- •Subjects with any history of immune system disorder or auto-immune disorder including but not limited to the following:
- •*AIDS, HIV, Ankylosing Spondylitis, Chronic Fatigue Syndrome, CREST syndrome, Crohn's disease, Dermatomyositis, Fibromyalgia, Grave's disease, Hashimoto's Thyroiditis, Lupus, Multiple Sclerosis, Myasthenia Gravis, Pernicious Anemia, PolyarteritisNodosa, Primary Biliary Cirrhosis, Psoriasis, Reynaud's Syndrome, Rhematoid Arthritis, Sarcoidosis, Scleroderma, Sjogren's Syndrome, Temporal Arthritis, Ulcerative Colitis, and Vitiligo
- •Use of any immunosuppressive drugs in the last 12 months (including steroids or biologics)
- •Any significant GI condition that would severely interfere with the evaluation of the study product including but not limited to inflammatory bowel disease (Ulcerative Colitis or Chron's), history of frequent diarrhea, history of surgery for weight loss (including gastric bypass or lapband), history of perforation of the stomach or intestines, gastroparesis, clinically important lactose intolerance
- •Any active infection, or infection in the last month requiring antibiotics, antiviral medication, or hospitalization History or presence of cancer in the prior two years, except for non-melanoma skin cancer.
- •Subjects with a history of seizure
- •Recent history of (within 12 months) or strong potential for alcohol or substance abuse.
- •Participation in a clinical study with exposure to any non-registered drug product within 30 days prior.
- •Subject who are using herbal products containing androgenic/anxiolytic activity within 30 days (one month washout is allowed)
- •Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk. Including subjects who are Bed or wheelchair-bound
- •Untreated or unstable Hypothyroidism
- •Subjects with active eating disorder including anorexia nervosa, bulimia, and/or obsessive compulsive eating disorders
- •Central Neurological disorders including but not limited to Spinal cord injuries, multiple sclerosis, Parkinson's disease
- •Pregnant, lactating, planning to become pregnant or unwilling to use adequate contraception during the duration of the study.
研究组 & 干预措施
Eurycomalongifoliawater extract (Physta®) +Multivitamin
Experimental
干预措施: Eurycomalongifoliawater extract (Physta®) (Dietary Supplement)
Eurycomalongifoliawater extract (Physta®) +Multivitamin
Experimental
干预措施: Multivitamin (Dietary Supplement)
Placebo
Placebo Comparator
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
The change in quality of life after 24 weeks of supplementation with study product, measured using the SF-12 Quality of Life Questionnaire
时间窗: 24 Week
The change in mood after 24 weeks of supplementation with study product, measured using the POMS Questionnaire
时间窗: 24 week
次要结局
- The change in stress after 24 weeks of supplementation with study product, measured using the Multi-Modal Stress Questionnaire(24 weeks)
- The change in fasting AM Cortisol levels after 24 weeks of supplementation with study product.(24 weeks)
研究者
相似试验
尚未招募
不适用
The Effects of Eurycoma Longifolia Water Extract (Physta®) on Well-Being of Peri and Postmenopausal WomeMenopauseACTRN12622001341718Biotropics Malaysia Berhad150
已完成
不适用
Efficacy and Safety of Eriobotyra Japonica Lindley Extract on Improvement of Cognitive FunctionCognitive FunctionNCT01734213Chonbuk National University Hospital60
已完成
2 期
Efficacy and Safety of Eriobotyra Japonica Lindley Extract on Improvement of Cognitive FunctionCognitive FunctionNCT01734200Chonbuk National University Hospital80
已完成
2 期
To Evaluate the Dose Response of 3 Doses of Euphorbia Prostrata in Patients With First and Second Degree HemorrhoidsHemorrhoidsNCT01041911Panacea Biotec Ltd102
终止
3 期
Efficacy and Safety of Eschscholtzia Californica in Treating Primary InsomniaSleep Initiation and Maintenance DisordersNCT02183233Boehringer Ingelheim49