myalgic encephalomyelitis/chronic fatigue syndrome
Conditions
Interventions
6-MSITC three times a day (9.6 mg / day) for 12 weeks.
Sponsors
Oka Takakazu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chalder Fatigue Scale Score | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Subjective symptoms 2. Quality of life and dysfunction indices (SF-36, ME/CFS PS) 3. Psychological indices (POMS2, HADS) 4. Physiological function indices (axillary temperature, non-invasive autonomic nervous function test, standing test, mechanical pain threshold) 5. Blood biomarkers 6. Sleep indices (Pittsburgh Sleep Quality Index, Sleep EEG) 7. Cognitive function indices (TMT-A) Safety evaluation items 1. Blood test 2. Diseases | — |
Contacts
Public ContactTakakazu Oka
International University of Health and Welfare Narita hospital
Outcome results
None listed