A Study on Reliability and Validity of the ‘Qi Blood Yin Yang Deficiency Questionnaire’
- Conditions
- Symptoms, signs and abnormal clinical and laboratory findings, NEC
- Registration Number
- KCT0001199
- Lead Sponsor
- Korea Institute of Oriental Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 150
(1) males and females aged 20 to 39; (2) the presence of unexplained fatigue that is continuous and repetitive for more than 6 months; (3) not chronic fatigue syndrome and idiopathic chronic fatigue; (4) agreement of doctor diagnosis; and (5) those who consent to participate in this trial and sign an informed consent statement after listening to a clear explanation of the purpose and characteristics of this clinical trial
(1) over 14 score of Perceived Stress Scale-10item(PSS-10item); (2) disagreement of 2 doctors' diagnoses; (3) the presence of the following conditions in the subject’s past history that might trigger chronic fatigue: (a) organic causes, such as acute or chronic liver disease (for example, hepatitis, liver cirrhosis), anemia, tuberculosis, chronic lung disease, cardiovascular disease (for example, heart failure, hypertension), endocrine/metabolic disease (for example, diabetes, thyroid gland disease, severe obesity), autoimmune disease (for example, rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis), malignant tumors, or infectious disease; and (b) psycho-social causes, such as depression, anxiety neurosis, recent severe stress, schizophrenia, alcoholism, or an eating disorder (anorexia nervosa, bulimia nervosa); (4) subjects who have taken the following drugs within the past 2 weeks: antihypertensive drugs, antidepressants, anti-anxiety agents, hypnotics, or antihistamines; (5) pregnant or breast-feeding women; (6) subjects who are participating in other clinical trials; (7) subjects who are overworked; (8) subjects who have experienced a hypersensitive reaction after clinical laboratory test; (9) subjects who equipped to a cardiac pacemaker ; (10) subjects who do not provide informed consent; and (11) others whose clinical trial conductors are considered inappropriate for participating in this trial
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Questionnaire results on the syndrome differentiation of consumptive disease
- Secondary Outcome Measures
Name Time Method Korean medical doctors' diagnosis results on the syndrome differentiation ;Health-related clinical pathology examination results;Score of stress response inventory (Fatigue Severity Scale, Chalder Fatigue Scale);Analytical variables of tongue image obtained through tongue imaging system;Output variables of dermometer (DDFAO)