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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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4 July 2016 |
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Main ID: |
NCT02807649 |
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Date of registration:
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07/01/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of Ginko and Cistanche Against Fatigue Symptoms
GkoCist |
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Scientific title:
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A 60-Day Clinical Study to Evaluate Nutrilite Ginko Biloba Cistanche Tablets in Relieving the Symptoms of Chronic Fatigue Syndromes Compared to Negative Control |
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Date of first enrolment:
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May 2015 |
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Target sample size:
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159 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02807649 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention
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Phase:
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N/A
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Contacts
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Name:
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Shuguang Li, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Fudan University, Department of Nutrition and Food Hygiene |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Be diagnosed as CFS by general practitioner and at least have four symptoms:
memory loss or lack of concentration, muscle pain, sleep disturbances, continuous
discomfort after labor; Or be diagnosed as CFS according to the clinical diagnosis 30-60
days before screening;
- Have normal electrocardiograms (ECG) and blood pressure during quiet respiration and
during exercises.
- Be willing to use reliable contraception methods during the study period (only for
volunteers with fertility).
- Agree not to take any medication, supplement or nutrition with promoting function to
exercise capacity;
- Be willing to comply with all the requirements and procedures of the study;
- Agree to sign the informed consent form;
- Fully understand the nature, objective and the potential risks and side effects of
the study.
Exclusion Criteria:
- BMI?28;
- Female on menopausal;
- Have participated in similar clinical trials within 6 months before the screening;
- Currently taking medicines for cardiovascular or metabolic disease ;
- Have flu/symptoms of viral infection within three months before the first visit;
- Have history of or be diagnosed of any of the following diseases that may affect the
study results: gastrointestinal disorders, hepatopathy, nephropathy, endocrine
disease, blood disorders, respiratory and cardiovascular diseases;
- Current or previous alcohol abuser, currently taking or took illicit drugs, substance
or over the counter prescription drugs which promote athletic performance;
- Subject with iron-deficiency anemia, diabetes mellitus, epilepsy, bleeding tendency
or Coagulation disorders;
- Currently suffering from any gastrointestinal disorders or skeletal muscle
dysfunction, including but not limited to: irritable bowel syndrome, colitis,
ulcerative colitis, celiac disease, osteoporosis or arthritis;
- Currently having or had any medical or nutritious therapies, including taking protein
supplements or nutrients that promote exercise capacity within 3 months before
screening;
- Have lost or gained weight over 5 kilograms within 3 months before screening;
- Had hospitalizations within 3 months before screening;
- According to investigator's judgement, current frequent users of drugs which may
affect the electrolyte balance or hydration.
- Pregnant or nursing female, as determined by a questionnaire.
Age minimum:
35 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Fatigue Syndrome
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Fatigue
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Mental Fatigue
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Intervention(s)
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Dietary Supplement: Placebo Comparator: Placebo
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Dietary Supplement: Experimental: Nutrilite® Low dose
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Dietary Supplement: Experimental: Nutrilite® High dose
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Primary Outcome(s)
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Net change in the score of World Health Organization Quality of Life survey before and after intervention
[Time Frame: 60 days]
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Secondary Outcome(s)
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Net change in the score of Chalder fatigue self assessment survey before and after intervention
[Time Frame: 60 days]
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Net change in the score of Chalder fatigue scale survey before and after intervention
[Time Frame: 60 days]
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Secondary ID(s)
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13-SC-4-STL-002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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