Chronic fatigue syndrom
Conditions
Interventions
Arm One:2 study products+ 1 placebo
Arm Two:3 study products
Arm Three:3 placebo
Sponsors
Amwany (China) R &D Center
Eligibility
Sex/Gender
All
Age
35 Years to 60 Years
Inclusion criteria
Inclusion criteria: 35~60 years old male or female subjects who: 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; 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
Exclusion criteria: 1. BMI >=28; 2. Female on menopausal; 3. Have participated in similar clinical trials within 6 months before the screening; 4. Currently taking medicines for cardiovascular or metabolic disease; 5. Have flu/symptoms of viral infection within three months before the first visit; 6. 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; 7. Current smoker; 8. Current or previous alcohol abuser, currently taking or took illicit drugs, substance or OTC prescription drugs which promote athletic performance; 9. Subject with iron-deficiency anemia, diabetes mellitus, epilepsy, bleeding tendency or Coagulation disorders; 10. 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; 11. Currently having or had any medical or nutritious therapies, including taking protein supplements or nutrients that promote exercise capacity within 3 months before screening; 12. Have lost or gained weight over 5 kilograms within 3 months before screening; 13. Had hospitalizations within 3 months before screening; 14. According to investigator's judgement, current frequent users of drugs which may affect the electrolyte balance or hydration; 15. Pregnant or nursing female, as determined by a questionnaire.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CFS Assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| WHOQOL BREF score;SLQQ score;Chalder Fatigue Scale (ChFS)?;Symptoms self-assessment.;Net change of serum Estradiol level in women;Net change of serum Testosterone levels in men; | — |
Countries
China
Contacts
Public ContactLi Shuguang
Outcome results
None listed