• Journal of Physiology & Pathology in Korean Medicine
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• v.21 no.5
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• pp.1185-1193
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• 2007

Ginsing polysaccharide, known to have an immune regulating effect, was administered to 23 randomly selected healthy male subjects with a mean age of 23 years in accordance with an IRB approval. Then, these subjects underwent physico-chemical tests and serum proteome was analyzed from the blood sample taken from these subjects. Analyses of proteome involved image analysis, protein sections and protein identification in sequence after two-dimensional electrophoresis was carried out. During the physico-chemical test, 4 subjects were excluded from the study. In the proteome analysis, identified were 5 spots such as SP40, 40, Cytokeratin 9, hypothetical protein LOC544932, Apolipoprotein E ,similar to Human albumin, which showed differences in the amount of protein expression. In conclusion, changes of 5 proteins were remarkable before and after administration of ginsing polysaccharides. In certain cases, hepatic and renal slight injury occurred. Thus, further clinical study on dosage regimen would be necessary for securing the basis for concentration-dependent effectiveness and safety.

• Asian Pacific Journal of Cancer Prevention
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• v.17 no.7
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• pp.3611-3614
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• 2016

Background: Propolis based preparations have a wide range of applications in various specialties of dentistry. The aim of this clinical trial was to test the efficacy of propolis as a mouthwash in the reduction of chemotherapy induced oral mucositis (OM) in a single center. Materials and Methods: In this randomised, controlled study patients undergoing chemotherapy were included consecutively and randomised to an experimental group receiving propolis mouthwash (n = 20) and a control group receiving diluted water (n=20). Oral mucositis, erythema and eating and drink ability were assessed at baseline and after 3 and 7 days using the World Health Organization (WHO) scale and the oral mucositis assessment scale (OMAS). Results: There were significant differences in OM, wound and erythema in propolis group compared to placebo, but no significant difference in eating and drink ability. However, it was interesting that 65% of the patients in the propolis group were completely healed at day 7 of the trial. No significant adverse events were reported by the patients. Conclusions: This study found that oral care with propolis as mouthwash for patients undergoing chemotherapy is an effective intervention to improve oral health. Our findings shouldlencourage health practitioners to apply propolis mouth rinse for the oral care of patients under chemotherapy.

• Journal of Menopausal Medicine
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• v.24 no.3
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• pp.204-209
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• 2018

Objectives: Aim of present study was designed to investigate the soporific effect of fennel among menopausal women. Methods: The present double-blinded and placebo-controlled trial examined the fennel effect on Pittsburgh Sleep Quality Index (PSQI). Total score and relevant 7 components, including sleep duration, sleep latency, use of sleeping medication, subjective sleep quality, sleep disturbances, daytime dysfunction and habitual sleep efficiency among 50 menopausal women compared to control group within a 12-week follow-up. Results: The patients in both groups reported no certain side effects and all subjects completed the study. The mean actual sleep duration was 5 hours and 66 minutes. Intergroup comparison revealed no statistically significant differences in the mean total PSQI score (P = 0.439), subjective sleep quality (P = 0.826), habitual sleep efficiency (P = 0.127), sleep disturbances (P = 0.130), use of sleeping medication (P = 0.52) and daytime dysfunction (P = 0.439). A tendency toward significant between 2 groups was seen concerning the sleep duration (P = 0.059). Intergroup comparison showed significantly borderline levels (P = 0.059). Conclusions: The treatment of 12 weeks with fennel caused a slight effect that did not reach to significant. These findings should be considered cautiously because of small sample size, short-term follow-up and subjective measure of sleep quality.

• Journal of the Korean Academy of Child and Adolescent Psychiatry
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• v.2 no.1
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• pp.87-96
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• 1991

A double bhad, placebo controlled study was performed to evaluate the therapeutic effects of Carbamazepine in autistic children, 23 boys with the diagnosis of Pervasive Developmental Disorders according to the DSM-IIIR were selected for study subjects, from Child and Adolescent Psychiatric Outpatient Department of Seoul National University Children Hospital during Oct. $1989{\sim}Nov.$ 1991. Subjects with histories of medical disease or psychiatric diseases were excluded and all study subjects had drug free periods more than 2 Months. Study subjects were randomly assigned to Cabamazepine treatment group(N=12) and placebo group(N=11). After the baseline observation periods, the double blind drug treatment and observation were performed for 12 weeks. Several scales (Ritvo-Freedman Real Life atring Scale. Behavior Checklist) were employed to evaluate the effects of drug treatment during baseline observation periods and the drug treatment periods by two raters blind to the study. Interrater reliability of each scales were .4875~.6613, the socrodemographic variables and the rating scores during baseline observation periods were not significantly different between two groups. Reduction of total scores in Autsm Behavior Checklist scale, i.e.. improvement of global autistic symptoms were noted significantly in Carbamazepine treatment group. Improvement in significant social maturations according to Vineland Social Mataration scale were observed in both patient groups after drug treetment periods.

• The Journal of Internal Korean Medicine
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• v.41 no.3
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• pp.326-338
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• 2020

Background: Alzheimer's disease (AD) is a chronic neurodegenerative disease that causes disorientation, mood swings, problems with language, and difficulty remembering recent events. Acetylcholinesterase inhibitors (AchEIs) and memantine have been used to slow the course of the disease, but they can neither modify its progression nor prevent disease onset. Previous studies have suggested that Kami-guibi-tang (KGT) could be beneficial for supporting cognitive function in AD patients, but few clinical trials have been published. This pilot study aimed to evaluate the effect of KGT in improving cognitive function in AD patients. Methods: The study will be a randomized, placebo-controlled, double-blind, single-center trial conducted using subjects diagnosed with mild AD by neurologists. Study subjects will be randomly assigned to either a treatment or control group. The treatment group will receive KGT granules for 24 weeks, while the control group will receive placebo granules. AchEI administration will be maintained in both groups during the entirety of the study. Subjects will be assessed using the following exams: the Seoul Neuropsychologic Screening Battery (SNSB) for cognitive function; brain magnetic resonance imaging (MRI) for brain metabolite, neurotransmitter, and cerebral blood flow (CBF) measurements; the Korean version of Quality of Life-Alzheimer's Disease (KQol-AD) for quality of life; the Caregiver-Administered Neuropsychiatric Inventory (CGA-NPI) for neurobehavioral symptoms; blood tests for amyloid and tau proteins and general blood parameters; and electrocardiography (ECG) before and after taking the medication. Discussion: Our findings will provide insight into the feasibility of large-scale trials to consolidate evidence for the efficacy of KGT for dementia treatment. Registration ID in CRIS: KCT0002904 (Clinical Research Information Service of the Republic of Korea).

• Journal of Oriental Neuropsychiatry
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• v.23 no.4
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• pp.133-152
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• 2012

Objectives : The purpose of this study is to investigate the effect of Sihogayonggolmoryeo-tang on the anxiety of Hwa-byung. Methods : In this randomized, double blinded, placebo-controlled study, we planned to give Sihogayonggolmoryeo-tang or controlled medication for anxiety of Hwa-byung. Hamilton Anxiety Scale (HAM-A) was measured as the 1st evaluative instrument, and Korean State-Trait Anxiety Inventory (STAI-K), Likert scale for major symptom of Hwa-byung, Hwa-Byung Scale Score, Korean Beck's Depression Inventory (BDI-K), Korean State-Trait Anger Expression Inventory (STAXI-K), Insomnia severity Index (ISI), Instrument of Oriental Medical Evaluation for Hwa-Byung, WHO Quality of Life Avvreviated (WHOQOL-BREF), genral self-Efficacy Scale (GSES), Rosenberg Self-Esteem Inventory (SRE) and Heart Rate Variability (HRV) were also measured as the 2nd evaluative instrument before treatment. Results : Clinical characteristics-vital signs and demographic characteristics showed no significant difference between both groups. The characteristics of disease-chief complaint, pattern Identification, period, etiological factor, and etc, also showed similarity of distribution in both groups. The results of Chest PA, EKG and clinicopathologic examination showed no significant difference between both groups. There were no significant difference between both groups in all valuation scales; HAM-A was measured as the first evaluative instrument, and STAI-K, Likert scale for major symptom of Hwa-byung, Hwa-Byung Scale Score, BDI-K, STAXI-K, ISI, Instrument of Oriental Medical Evaluation for Hwa-Byung, WHOQOL-BREF, GSES, SRE and HRV. Conclusions : We considered that establishment of the experimental group and controlled group was objective and worth conducting this research. In addition, this methodology is expected to be applied to the subsequent research. Further, we hope to make up for this study through various study and discussion.

• Dementia and Neurocognitive Disorders
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• v.22 no.3
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• pp.100-108
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• 2023

Background and Purpose: The efficacy and safety of GV1001 have been demonstrated in patients with moderate-to-severe Alzheimer's disease (AD). In this study, we aimed to further demonstrate the effectiveness of GV1001 using subscales of the Severe Impairment Battery (SIB), which is a validated measure to assess cognitive function in patients with moderate-to-severe AD. Methods: We performed a post hoc analysis of data from a 6 month, multicenter, phase 2, randomized, double-blind, placebo-controlled trial with GV1001 (ClinicalTrials.gov, NCT03184467). Patients were randomized to receive either GV1001 or a placebo for 24 weeks. In the current study, nine subscales of SIB-social interaction, memory, orientation, language, attention, praxis, visuospatial ability, construction, and orientation to name-were compared between the treatment (GV1001 1.12 mg) and placebo groups at weeks 12 and 24. The safety endpoints for these patients were also determined based on adverse events. Results: In addition to the considerable beneficial effect of GV1001 on the SIB total score, GV1001 1.12 mg showed the most significant effect on language function at 24 weeks compared to placebo in both the full analysis set (FAS) and per-protocol set (PPS) (p=0.017 and p=0.011, respectively). The rate of adverse events did not differ significantly between the 2 groups. Conclusions: Patients with moderate-to-severe AD receiving GV1001 had greater language benefits than those receiving placebo, as measured using the SIB language subscale.

• Phonetics and Speech Sciences
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• v.2 no.1
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• pp.99-112
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• 2010

This study attempted to review the recent, high-quality evidence-based practical research related to the treatment effectiveness of voice disorders which focus on randomized controlled trials (RCTs) and translational research of vocal fold tissue engineering for vocal fold regeneration. Methodology including PICO (P; Populations or Patients, I; Interventions, C; Comparison group (control, placebo, gold standard), O; Outcomes or measures made) information for RCTs and animal models (species), regenerative therapy method, and outcomes of translational research for clinical application was summarized and discussed for future voice disorder research.

• Journal of Oriental Neuropsychiatry
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• v.20 no.3
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• pp.169-188
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• 2009

Objectives : The purpose of this research is to examine the effect of Bunsimgi-eum on the chest discomfort of Hwa-byung's major symptom. Methods : In this randomized, double blinded, placebo-controlled study, we planned to give Bunsimgi-eum or controlled medication for major symptoms of Hwa-byung. As preparatory research, 100 mm Visual Analogue Scale(VAS) for chest discomfort, the Hwa-byung' major symptom was measured as the 1st evaluative instrument, and Likert scale for major symptom of Hwa-byung, Korean State-Trait Anger Expression Inventory(STAXI-K), Korean State-Trait Anxiety Inventory(STAI-K), Korean Beck's Depression Inventory(BDI-K) and Heart Rate Variability(HRV) were also measured as the 2nd evaluative instrument at the before treatment. Results : Clinical characteristics-vital signs & demographic characteristics showed no significant difference between both groups. The characteristics of disease-chief complaint, pattern Identification, period, etiological factor, etc, also showed no significant difference between both groups. There were almost no Coincidence between pattern identification & weight of Hwa-byung's major symptoms. The results of Chest PA, EKG and clinicopathologic examination showed no significant difference between both groups. There were no significant difference between both groups in all valuation scales; 100 mm Visual Analogue Scale for chest discomfort, the Hwa-byung' major symptom was measured as the 1st evaluative instrument, and Likert scale for major symptom of Hwa-byung, STAXI-K, STAI-K, BDI-K and HRV. Conclusions : We considered that establishment of experimental group and controlled group was objective and worth conducting this research. And this methodology is expected to be applied to the subsequent research. And also, we hope to make up for this study through various study and discussion.

• The Journal of Internal Korean Medicine
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• v.28 no.1
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• pp.106-114
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• 2007

Background : Mahuang (Ephedrae Herba, Ephedra sinica $S_{TAPE}$) has been widely used to treat respiratory disease in Asian over the past thousand years. The main ingredient of Mahuang is ephedrine, whose affects on the autonomic nervous system induce some adverse effects like vasoconstriction, hypertension, tachycardia, miosis, insomnia, dizziness, headache, etc. Although there were lots of reports about adverse effects of Mahuang, there were no clinical studies which evaluated the adverse effects of Mahuang on the autonomic nervous system by objective numerical value in the past decade. Objectives : The purpose of this report was to provide an objective assessment of state-trait anxiety that is caused by Mahuang, and to identify anxiety of Mahuang according to different Sasang constitution classifications. Methods : The study design was a double-blind randomized placebo-controlled trial. The subjects of this study were 79 adults aged between 20 to 40 who agreed to participate. Because 8 adults dropped out, a total of 71 subjects entered the study. They were allocated through randomization to a Mahuang group (N=50) and placebo group (N=21). Each group took three opaque capsules (every opaque capsule containing 2g of Mahuang or none) twice a day. To compare the state and trait anxiety before and after taking Mahuang, we checked the anxiety by using STAI-KYZ. Results : The following results were obtained. Short-term administration of Mahuang significantly increased state-anxiety, but in the placebo group, there were no significant changes in state-anxiety. In the Mahuang group except females, there was more significant increase in state-anxiety of Soeumin than Soyangin and Taeumin in the 2nd measurement. Conclusion : It is suggested that the ingestion of Mahuang can increase sympathetic activity and induce anxiety. There was a significant difference among Sasang constitution classification. Especially, the response is stronger in Soeumin than other constitutions. If we use Mahuang according to the Sasang constitution classification in clinic, we could not only minimize the anxiety but maximize the potential curative value.