A study of the clinical effects of 6-MSITC on chronic fatigue syndrome
- Conditions
- myalgic encephalomyelitis/chronic fatigue syndrome
- Registration Number
- JPRN-jRCTs031190205
- Lead Sponsor
- Oka Takakazu
- Brief Summary
This study suggests that 6-MSITC-containing supplements (9.6 mg of 6-MSITC per day) are a safe and effective ingredient for especially improving PS levels and cognitive function in patients with ME/CFS. It was also suggested to improve the frequency of headaches and myalgia and to improve vitality and overall sense of wellness of patients with this illness. Therefore, 6-MSITC-containing supplements may be a useful treatment option for ME/CFS patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 15
1. Those who can be diagnosed as ME / CFS, according to the CDC diagnostic criteria (Fukuda1994) and the Ministry of Health, Labor and Welfare research group clinical diagnostic criteria (2017)
2. Those who are 20 to 69 years old (regardless of gender)
3. The performance status (severity of fatigue) is 3 and more, according to the ME / CFS clinical diagnostic criteria (2017), Table 3.
4. Those who can fill in self-rating questionnaires by themselves
5. Those who can come to the hospital at least once a month
6.Those whose consent judgment ability is judged to be sufficient
1. Those whose fatigue is due to known physical diseases (liver, kidney, heart, respiratory, endocrine, autoimmune, or malignant diseases, anemia, electrolyte abnormalities, etc.)
2. Women who are pregnant or breastfeeding, who may become pregnant or who wish to become pregnant during this study
3. Those who have taken or are currently taking supplements containing 6-MSITC
4. Those who are judged to be inappropriate by the principal investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Chalder Fatigue Scale Score
- Secondary Outcome Measures
Name Time Method 1. Subjective symptoms<br>2. Quality of life and dysfunction indices (SF-36, ME/CFS PS)<br>3. Psychological indices (POMS2, HADS)<br>4. Physiological function indices (axillary temperature, non-invasive autonomic nervous function test, standing test, mechanical pain threshold)<br>5. Blood biomarkers<br>6. Sleep indices (Pittsburgh Sleep Quality Index, Sleep EEG)<br>7. Cognitive function indices (TMT-A)<br><br>Safety evaluation items<br>1. Blood test<br>2. Diseases