None listed
Conditions
Interventions
Drug : trial group: Samultang 3g + folic acid 1mg
control group: folic acid 1mg
- Samultang : 3 time /1 day, 8 weeks
- folic acid : 1 time /1 day, 8 weeks
Sponsors
Konyang University Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. a history of 2 or more miscarriages with blood natural killer cell level 16.1% or higher or blood natural killer cell cytotoxicity E:T ratio 50:1 34.3% or higher 2. recent miscarriage: 2- 6 months 3. Chalder Fatigue Scale Questionnaire (CFQ) 15 or higher
Exclusion criteria
Exclusion criteria: (1) Pregnant women (pregnant test positive) or lactating women (2) Patients with autoimmune diseases (antiphospholipid antibodies, lupus, etc.) (3) A person with anatomical factors of recurrent miscarriage (4) Those with uncontrolled endocrine factors (hyperthyroid disease, diabetes, etc.) (5) Patients with liver and renal dysfunction (ALT or AST, 3 times the normal upper limit when screening, and blood creatine or BUN 2 times the normal upper limit) (6) A person with a history of severe organic diseases (heart, lung, liver, and kidney disease) (7) Persons with central nervous system disorders or psychiatric history or taking psychotropic drugs (8) A person who has taken a drug that may affect the improvement of fatigue, fatigue symptoms within two weeks prior to the screening visit or is scheduled to take it during the study period; (9) A person who has taken the relevant medication for the purpose of repeated miscarriage treatment within two weeks prior to the screening visit or is scheduled to take it during the period of administration of this study. (10) A person who has taken or plans to take any health functional food, food, medicine or other herbal medicine (pharmaceutical) that may affect the effectiveness of the test drug within two weeks prior to the screening visit [see list and criteria below] (11) Those who have a history of serious drug allergies or are hypersensitive to the main ingredients and their components of the test drug: Those who have genetic problems such as galactose intolerance, Lapp lactose (lactose) degradation enzyme deficiency, or glucose-galactose absorption disorder. (12) A person who has participated in another clinical trial in which treatment intervention has been performed within the last three months; (13) Any other person deemed inappropriate by the clinical trial director or clinical trial manager to participate in this clinical trial (14) Those subject to clinical trials that require prompt immunoglobulin treatment or assisted reproductive procedures at the judgment of the clinical trial manager
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Chalder Fatigue Scale Questionnaire (CFQ) total score | — |
Secondary
| Measure | Time frame |
|---|---|
| CRP, fibrinogen, Hb, Ferritin, glucose, IL-6, NK cell proportion, NK cell cytotoxicity | — |
Countries
Korea, Republic of
Contacts
Public ContactSung Ki Lee
Konyang University Hospital
Outcome results
None listed