| Literature DB >> 28664132 |
Protocol for the evaluation and validation of Qi Blood Yin Yang deficiency pattern questionnaire: prospective observational study.
Jihye Kim1, Keun Ho Kim1.
Abstract
BACKGROUND: The aim of this study is to validate the pattern identification standard of qi, blood, yin, and yang deficiency patterns diagnosis. The current study will investigate the usefulness of the Qi Blood Yin Yang deficiency pattern questionnaire as a diagnostic tool for qi, blood, yin, and yang deficiencies by assessing the agreement between the scores and a gold standard established by assessors.METHODS: This protocol is for a single center, prospective, observational study. A total of 248 eligible patients with unexplained chronic fatigue will be assigned to four groups in a 1:1:1:1 ratio as the qi deficiency group, blood deficiency group, yin deficiency group, and yang deficiency group. The primary outcome will be measured using the score of the Qi Blood Yin Yang deficiency pattern questionnaire and the secondary outcomes will be measured using the fatigue severity scale, Korean-translated chalder fatigue scale, computerized tongue image analysis system, and three types of pattern identification questionnaires (cold-heat, food accumulation, and seven emotions patterns). The safety of the clinical study will be assessed after measurements at every visit. All statistical analysis will be performed using the R Statistics program. Statistics experts will analyze the relationship between clinical data using the Pearson's Chi-squared test and independent t-test. DISCUSSION: This study will provide reference data and good evidence that are applicable to future studies. Furthermore, the results of the present study are useful to improve the care of patients with unexplained chronic fatigue and unexplained chronic fatigue-related disorders.
Entities:
Keywords: Qi Blood Yin Yang deficiency pattern questionnaire; study protocol; unexplained chronic fatigue; validation
Year: 2015 PMID： 28664132 PMCID： PMC5481822 DOI： 10.1016/j.imr.2015.10.002
Source DB: PubMed Journal: Integr Med Res ISSN： 2213-4220
Background
Methods
Study design
Fig. 1Study schedule for participants. Participants with a diagnosis of unexplained chronic fatigue were recruited at the Won Kwang University of Traditional Korean Medicine. A total of 248 patients were enrolled to four groups: qi deficiency group A, blood deficiency group B, yin deficiency C, and yang deficiency D in a 1:1:1:1 ratio. The outcome was measured at every visit.
Table 1
Study design schedule
| Period | Screening | Measurement 1 | Measurement 2 |
|---|---|---|---|
| Informed consent | • | ||
| Inclusion and exclusion criteria | • | ||
| Characteristics information | • | ||
| Vital signs | • | • | |
| Medical history | • | ||
| Diagnosis of PI | • | ||
| Diagnosis of chronic fatigue | • | ||
| PSS | • | ||
| QBYY-Q | • | • | |
| PI-Q | • | • | |
| FSS | • | • | |
| CFS | • | • | |
| Laboratory test | • | ||
| Acquisition of tongue image | • | • | |
| Patient's compliance | • | • | • |
| Adverse event | • | • | • |
•: Item has to be carried out for the visit in all participations.
(1) Check the inclusion and exclusion criteria; (2) characteristics information: age, sex, date of birth, smoking, alcohol, caffeine, disease history, surgery history, drug taking, menstrual period, etc.; (3) vital signs: height, weight, temperature, systolic and diastolic pressure; (4) diagnosis of following pattern identification of patients: qi deficiency, blood deficiency, yin Deficiency, and yang deficiency; (5) All laboratory test results should be interpreted within the normal reference values. Laboratory test: blood test (complete blood cell count, white blood cells, differential cell count, erythrocyte sedimentation rate, alkaline phosphatase, aspartate transaminase, alanine transaminase, protein, albumin, blood urea nitrogen, creatinine, gamma-glutamyl transferase, total bilirubin, direct bilirubin, uric acid, C-reactive protein, sodium, potassium, chloride, thyroid stimulating hormone) and urinalysis (pH, specific gravity, protein, glucose, ketone, bilirubin, urobilinogen, nitrite, urine micro red blood cells, white blood cells); (6) acquisition of tongue image by computerized tongue image analysis system; (7) check whether participation is enrolled or not by interview and case report form; and (8) medical examination by interview and self-report of adverse event.
CFS, chronic fatigue syndrome; FSS, Fatigue Severity Scale; PI, pattern identification; PI-Q, pattern identification questionnaires (cold-heat, food accumulation and seven emotions patterns); PSS, Perceived Stress Scale; QBYY-Q, Qi Blood Yin Yang deficiency questionnaire
Recruitment of participants
Recruitment strategies
Participants
Inclusion criteria
Exclusion criteria
Withdrawal criteria
Sample size
Diagnostic criteria
Diagnosis of UCF
Diagnosis of PI
Measurements
Primary outcome
Secondary outcome
CTIS
Fig. 2Photograph of the scene of acquisition of the tongue image.
PI-Qs
Fatigue questionnaires
Follow up
Randomization and blinding
Safety monitoring
Quality control and monitoring
Data management
Statistical analysis
Ethics
Discussion
Conflicts of interest
| Condition | 1 | 2 | 3 | 4 |
|---|---|---|---|---|
| I feel listless | □ | □ | □ | □ |
| I feel too languid to work | □ | □ | □ | □ |
| I feel feeling of helplessness | □ | □ | □ | □ |
| I attempt the impossible | □ | □ | □ | □ |
| I do not gain weight despite eating fully | □ | □ | □ | □ |
| I feel giddy | □ | □ | □ | □ |
| My heart keeps pounding | □ | □ | □ | □ |
| I feel dull pain in my low back or knee | □ | □ | □ | □ |
| I feel weak and cannot move around much | □ | □ | □ | □ |
| I feel hot deep in the body, hand, and foot | □ | □ | □ | □ |
| I often have a cramp | □ | □ | □ | □ |
| I have a flush in the afternoon | □ | □ | □ | □ |
| I have a pale complexion | □ | □ | □ | □ |
| I have a rough skin | □ | □ | □ | □ |
| My hair is friable | □ | □ | □ | □ |
| I have a bad complexion of lips, lids, and nail | □ | □ | □ | □ |
| I have a dry and fatigue eyes | □ | □ | □ | □ |
| I have a failure of eyesight | □ | □ | □ | □ |
| I have a dry mouth | □ | □ | □ | □ |
| I haven’t had my appetite lately | □ | □ | □ | □ |
| I have a fever in the afternoon | □ | □ | □ | □ |
| I prefer warm thing to cold thing | □ | □ | □ | □ |
| I prefer warm beverages to cold beverages | □ | □ | □ | □ |
| My hands and feet get cold | □ | □ | □ | □ |
| I usually sweat a lot these days | □ | □ | □ | □ |
| I sweat during sleep | □ | □ | □ | □ |
| The voice is getting smaller | □ | □ | □ | □ |
| I frequently had a dream during sleep | □ | □ | □ | □ |
| I urinate frequently during feel cold | □ | □ | □ | □ |
| I have diarrhea in the dawn | □ | □ | □ | □ |
| I have soft stools | □ | □ | □ | □ |
| I have s symptoms of proctoptosis and hysteroptosis | □ | □ | □ | □ |
14 in total
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1 in total
1. The Effects of Radix Astragali Water Abstract on Energy Metabolism in Rat Yang-Deficiency Cold Syndrome Model through PPAR Signaling Pathway.
Journal: Evid Based Complement Alternat Med Date: 2018-11-01 Impact factor: 2.629
1 in total