• Title/Summary/Keyword: Placebo-controlled study

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A single-center, randomized, double-blind, placebo-controlled study on the efficacy and safety of "enzyme-treated red ginseng powder complex (BG11001)" for antiwrinkle and proelasticity in individuals with healthy skin

  • Park, Sang-Yong;Shin, Yu-Kyong;Kim, Hee-Taek;Kim, Yong Min;Lee, Don-Gil;Hwang, Eunson;Cho, Byung-Goo;Yin, Chang Shik;Kim, Ki-Young;Yi, Tae Hoo
    • Journal of Ginseng Research
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    • v.40 no.3
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    • pp.260-268
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    • 2016
  • Background: During the aging process, skin shows visible changes, characterized by a loss of elasticity and the appearance of wrinkles due to reduced collagen production and decreased elasticity of elastin fibers. Panax ginseng Meyer has been used as a traditional medicine for various diseases due to its wide range of biological activities including skin protective effects. Ginsenosides are the main components responsible for the biological activities of ginseng. However, the protective activities of an enzymatic preparation of red ginseng against human skin aging have not been investigated. Methods: The efficacy of an enzyme-treated powder complex of red ginseng (BG11001) in preventing human skin aging was evaluated by oral administration to 78 randomized individuals. All patients were requested to take three daily capsules containing either 750 mg of BG11001 or a placebo vehicle for 24 wk; at the end of the testing period, skin roughness, elasticity, and skin water content were measured. Results: BG11001 significantly reduced the average roughness of eye wrinkles and the Global Photo Damage Score compared with the placebo, although there were no significant differences in arithmetic roughness average between the groups. In addition, gross elasticity and net elasticity values increased, and transepidermal water loss level decreased, indicating improved skin elasticity and moisture content. Conclusion: In conclusion, enzyme-treated red ginseng extract significantly improved eye wrinkle roughness, skin elasticity, and moisture content. Moreover, enzyme-treated red ginseng extract would be useful substance as a bio-health skin care product.

A Clinical Trial of Dextranase-Containing Mouthwash on the Inhibition of Plaque Formation and Gingivitis (Dextranase 함유 구강 세정액의 치태 억제 및 치은염 예방 효과에 관한 임상적 연구)

  • Song, Woo-Sung;Son, Eun-Ju;Kim, Do-Man;Chung, Hyun-Ju
    • Journal of Periodontal and Implant Science
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    • v.31 no.2
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    • pp.371-388
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    • 2001
  • A novel glucanhydrolase(DXAMase) from a mutant of Lipomyces starkeyi(KSM 22) has been shown effective in hydrolysis of mutan, reduction of mutan formation by Streptococcus mutans and removal pre-formed sucrose-dependentadherent microbial film and DXAMase has been strongly bound to hydroxyapatitie. These in vitro properties of Lipomyces starkeyi DXAMase are desirable for its application as a dental plaque control agent. This study was performed to determine the adjunctive oral hygiene benefits and safety of dextranase(Lipomyces starkeyi KSM 22 DXAMase)-containing mouthwash when used alongside normal tooth-brushing. This 6-month clinical trial was placebo-controlled double-blind design evaluating 1U/ml dextranase mouthwash and 0.12% chlorhexidine mouthwash. A total 39 systemically healthy subjects, who had moderate levels of plaque and gingivitis were included. At baseline, 1, 3 and 6 months, subjects were scored for plaque accumulation(Turesky modification of Quingley-Hein's plaque index), gingivitis status($L\ddot{o}e$ and Silness gingival index), and tooth stain(Area and severity index system by Lang et al). Additionally, oral mucosal examinations were performed and subjects questioned for adverse symptoms. Two weeks after pre-experiment examinations and a professional prophylaxis, the subjects provided with allocated mousewash and instructed to use 20-ml volumes for 30s twice daily after toothbrushing. All the groups showed significant increase in plaque accumulation since 1 month of experiment. During 6 months' period, the Dextranase mouthwash group showed the least increase in plaque accumulation, compared to the Chlorhexidine mouthwash and placebo groups. As for gingival inflammation, all the groups showed significant increase during 6 months of experiment. The Experimental group(Dextranase mouthwash) also showed the least increase in gingival index score, compared to the Positive control(Chlorhexidine mouthwash)as well as the Negative control(placebo)groups. Whereas the tooth stain was increased significantly in the Positive control group, compared to the baseline score and the Negative controlgroup since 3 months of mouthrinsing. It was significantly increased after 6 months in the Experimental group, still less severe than the Positive control group. As for the oral side effect, the Experimental group showed less tongue accumulation, bad taste, compared to the Positive control group. From these results, mouthrinsing with Lipomyces starkeyi KSM 22 dextranase provided adjunctive benefits to toothbrushing, comparable to 0.12% chlorhexidine mouthwash in inhibition of plaque accumulation and gingival inflammation and local side effects were if anything less frequent and less intense than chlorhexidine, with long-term use of the mouthwash. All data had provided positive evidence for Lipomyces starkeyi KSM 22 dextranase as an antiplaque agent and suggested that further development of dextranase formulations for plaque control are warranted.

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Hypoglycemic Properties of Polysaccharides Extracted from Ganoderma lucidum in Alloxan-Induced Diabetic Rats

  • Gao, Yihuai;Gao, He;Chan, Eli;Tan, Wenbo;Lan, Jin;Koh, Hwee-Ling;Chen, Guoliang;Zhou, Shufeng
    • Preventive Nutrition and Food Science
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    • v.9 no.3
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    • pp.240-244
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    • 2004
  • A recent randomized and double-blind placebo-controlled clinical study bas indicated that Ganoderma lucidum polysaccharides (GLP) decrease blood glucose in patients with type II diabetes. The aim of this study was to investigate the effect of the GLP extract in alloxan-induced diabetic rats. Oral administration of GLP at 0.25, 0.5 and 1.0 g/kg for 4 weeks resulted in a reduction of blood glucose levels by 12.5, 18.7 and 33.7% respectively, while glibenclamide treatment brought the hyperglycemic value down to normal. The hyperglycemic effect was supported by a significant decrease in glycosylated haemoglobin and increased plasma insulin levels (p<0.01) in a dose- and time-dependent manner. This study showed that GLP has similar hypoglycemic effects as glibenclamide in alloxan-induced diabetic rats.

Analysis of Safety of Mahuang in Studies for Treatment of Obesity (비만 치료 연구에서 마황의 안전성 분석)

  • Cho, Minjin;Kim, Sungha;Kim, Hojun;Song, Mi Young
    • Journal of Korean Medicine for Obesity Research
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    • v.21 no.2
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    • pp.95-104
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    • 2021
  • Objectives: The purpose of this study is to analyze the adverse events and safety of Mahuang used as anti-obesity treatment in Korean medicine. Methods: PubMed, EMBASE, Cochrane, KoreaMed, Oriental Medicine Advanced Searching Integrated System (OASIS) and SCIENCE-ON were used as searching for randomized controlled trials investigating the safety of Mahuang for treating obesity from January, 2000 to July, 2021. Results: Total 6 studies were included for analyzing. In most studies, heart rate was higher in experimental group than in placebo group with statistically significant difference. Both systolic and diastolic blood pressure had no significant differences between both groups, but systolic blood pressure got lower in experimental group. Most adverse events reported in experimental group were dry mouth, constipation, diarrhea, palpitation and insomnia, but serious adverse events were not reported. Conclusions: This study provides the evidence about the safety of Mahuang for treating obesity. However, increase of heart rate and minor adverse events could be occurred. Further study is needed to confirm the safety of Mahuang.

The Effects of Distilled Astragali Radix Herbal Acupuncture, Wild Ginseng Herbal Acupuncture and Rehmannia Glutinosa Herbal Acupuncture on Vital Sign;A Randomized, Placebo-controlled, Double-blind Clinical Trial (수종의 약침제제 견정혈 자입이 활력징후 변화에 미치는 영향;황기 약침, 산삼 약침, 생지황 약침을 중심으로)

  • Lee, Hei-Yong;You, Jeong-Seok;Yook, Tae-Han;Hong, Kwon-Eui
    • Journal of Acupuncture Research
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    • v.24 no.5
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    • pp.207-217
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    • 2007
  • Objectives: We investigated the safty of distilled Astragali Radix Herbal Acupuncture, Wild Ginseng Herbal Acupuncture and Rehmannia glutinosa Herbal Acupuncture on vital sign -BP, pulse, resperation-in adult man. Methods : We investigated on 106 healthy volunteers consisted of each 30 subjects in experiment (distilled Astragali Radix Herbal Acupuncture, Wild Ginseng Herbal Acupuncture and Rehmannia glutinosa Herbal Acupuncture) group and 30 subjects in control(Normal Saline) group. Study form was a randomized, placebo-controlled, double-blind clinical trial. 30 subjects in each experiment group were injected distilled Astragali Radix Herbal Acupuncture, Wild Ginseng Herbal Acupuncture, Rehmannia glutinosa Herbal Acupuncture at $GB_{21}$(Kyonjong) and 30 subjects in control group were injected Normal Saline at $GB_{21}$ (Kyonjong). except of 2 subjects(in control group) who can't be measured and 10 subjects(6 in experiment group and 4 in control group) who move or make unforceable error during measuring. Finally each 25. subject, subject, subject in experiment group and 24 subject in control group are studied. We measured resperation by PolyG-I and BP & pulse by electric manometer on 5 times : before injection per 5 minutes during and after injection per 10 minutes during 35 minutes. The SPSS 13.0 for windows was used to analyze the data and the Student t test(between two groups) were used to verify the result. Results : 1. After distilled Astragali Radix Herbal Acupuncture injection, Wild Ginseng Herbal Acupuncture and Rehmannia glutinosa Herbal Acupuncture , systolic BP is not significantly change in all experiment time. 2. After distilled Astragali Radix Herbal Acupuncture injection, Wild Ginseng Herbal Acupuncture and Rehmannia glutinosa Herbal Acupuncture , diastolic BP is not significantly change in all experiment time. 3. After distilled Astragali Radix Herbal Acupuncture injection, Wild Ginseng Herbal Acupuncture and Rehmannia glutinosa Herbal Acupuncture , pulse is not significantly change in all experiment time. 4. After distilled Astragali Radix Herbal Acupuncture injection, Wild Ginseng Herbal Acupuncture and Rehmannia glutinosa Herbal Acupuncture , resperation is not significantly change in all experiment time. Conclusions : The results suggest that distilled Astragali Radix Herbal Acupuncture, Wild Ginseng Herbal Acupuncture and Rehmannia glutinosa Herbal Acupuncture in healthy adult man don't influence vital sign within normal range. This result is derived from that distilled Astragali Radix Herbal Acupuncture, Wild Ginseng Herbal Acupuncture and Rehmannia glutinosa Herbal Acupuncture in healthy adult man are safety.

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The Effects of Ginseng and American Ginseng on General Symptom in Koreans and Chineses - Double-blind Randomized Controlled Trials - (한국인과 중국인에서 인삼과 서양삼 복용후 전신 증상 -이중맹검 무작위배정 임상시험-)

  • Seo, Jung-Cjul;Han, Sang-Won;Byun, Joon-Seok;An, Hee-Duk;Han, Il-Do;Cho, Geon-Ho;Leem, Kang-Hyun;Heo, Zheng-Jie;Yi, Jinglin;Jin, Mingxiu
    • Journal of Ginseng Research
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    • v.29 no.1
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    • pp.27-36
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    • 2005
  • In East-South Asia it has been said that ginseng(Panax ginseng) induces flushing and epistaxis, whereas American ginseng(Panax quinquefolius) dosen't. This study was designed to find out if ginseng really could increase flushing and epistaxis, compared with American ginseng. Double-blind randomized controlled trials on general symptom, such as flushing and epistaxis, of ginseng and American ginseng in Koreans and Chinese were performed by questionnaire. There was no significant accident or improvement in Koreans. But in Chinese dried mouth was significantly observed in placebo group and chest discomfort was significant in placebo group and American ginseng(4 years) group. In addition in Chinese chest discomfort was significantly observed in American ginseng(4 years) group and American ginseng(6 years) group. It was revealed that ginseng might not increase flushing and epistaxis.토양환경학회 홈페이지 ( http://www.kossge.or.kr ) 을 참조하십시오.

Synbiotics use for preventing sepsis and necrotizing enterocolitis in very low birth weight neonates: a randomized controlled trial

  • Pehlevan, Ozge Serce;Benzer, Derya;Gursoy, Tugba;Karatekin, Guner;Ovali, Fahri
    • Clinical and Experimental Pediatrics
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    • v.63 no.6
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    • pp.226-231
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    • 2020
  • Background: Probiotics and prebiotics have strain-specific effects on the host. Synbiotics, a mixture of probiotics and prebiotics, are proposed to have more beneficial effects on the host than either agent has alone. Purpose: We performed a randomized controlled trial to investigate the effect of Lactobacillus and Bifidobacterium together with oligosaccharides and lactoferrin on the development of necrotizing enterocolitis (NEC) or sepsis in very low birth weight neonates. Methods: Neonates with a gestational age ≤32 weeks and birth weight ≤1,500 g were enrolled. The study group received a combination of synbiotics and lactoferrin, whereas the control group received 1 mL of distilled water as placebo starting with the first feed until discharge. The outcome measures were the incidence of NEC stage ≥2 or late-onset cultureproven sepsis and NEC stage ≥2 or death. Results: Mean birth weight and gestational age of the study (n=104) and the control (n=104) groups were 1,197±235 g vs. 1,151±269 g and 29±1.9 vs. 28±2.2 weeks, respectively (P>0.05). Neither the incidence of NEC stage ≥2 or death, nor the incidence of NEC stage ≥2 or late-onset culture-proven sepsis differed between the study and control groups (5.8% vs. 5.9%, P=1; 26% vs. 21.2%, P=0.51). The only significant difference was the incidence of all stages of NEC (1.9% vs. 10.6%, P=0.019). Conclusion: The combination of synbiotics and lactoferrin did not reduce NEC severity, sepsis, or mortality.

Efficacy of Needling at Sympathetic Point (an Auricular Acupuncture Point) in Migraine Patients: A Randomized Controlled Study

  • O. Deepika;A. Mooventhan;N. Mangaiarkarasi;N. Manavalan
    • Journal of Acupuncture Research
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    • v.41 no.2
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    • pp.115-120
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    • 2024
  • Background: Migraine is a common disabling headache that affects every aspect of a person's life. Auricular acupuncture is a cost-effective treatment modality for the management of painful neurological conditions. Previous studies have shown the beneficial effects of a combination of ear points in the management of migraines. However, no studies have evaluated the efficacy of a single auricular point (i.e., sympathetic point) in migraine. Thus, this study evaluated the efficacy of sympathetic points on pain intensity and depression levels in patients with migraine. Methods: In this randomized controlled study, 100 patients with migraine aged 18-45 years were randomly divided into either an auricular acupuncture group (AAG) (n = 50) or a placebo control group (PCG) (n = 50). The AAG underwent needling at the sympathetic point (an auricular acupuncture point), whereas the PCG underwent needling at a non-acupuncture point for 20 minutes daily for 7 days. Assessments were performed before and after the intervention using a 6-item headache impact test (HIT-6) and Beck depression inventory (BDI) scale. Statistical analyses were performed using SPSS version 16. Results: In within-group analysis, the AAG showed a significant reduction in HIT-6 and BDI, whereas the PCG showed a significant increase in HIT-6 and a significant reduction in BDI. In between-groups analyses, HIT-6 reduced significantly in the AAG compared with that in the PCG, whereas BDI reduced significantly in the PCG compared with that in the AAG. Conclusion: In patients with migraine, needling at the sympathetic point produces a greater reduction in the pain intensity level and lesser reduction in the depression level compared to needling at a non-acupuncture point.

A Review on External Treatment for Atopic Dermatitis in Korean Journals (아토피 피부염의 외치법에 대한 고찰;국내 논문을 중심으로)

  • Shin, Sang-Ho;Kim, Mi-Bo;Byun, Seok-Mi;Lee, Ho-Sub;Park, Sun-Gyoo;Ko, Woo-Shin;Yoon, Hwa-Jung
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.21 no.2
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    • pp.80-93
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    • 2008
  • Objective : The purpose of this study is to investigate the results of preceding research related external treatment for Atopic dermatitis(AD). Methods : We studied the 13 research papers that had been published in The Journal of Korean Oriental Medical Ophthalmology & Otolaryngology & Dermatology, The Journal of Korean Oriental Pediatrics, The Journal of Korean Oriental Internal Medicine, The Journal of Korean Oriental Medicine, Korean Journal of Oriental Physiology & Pathology and so on. Results : About 13 treatises, 3 treatises were for the literatual study, I treatise was for the clinical research about the effects of external therapy, 3 treatises were for the effects of herbal medicine along with external treatment on AD development in NC/Nga mice, 6 treatises were for the case of AD. Conclusion : These treatises showed that external treatment is effective method to improve AD. To develop the better external treatment on AD, we have need of studies on the well used prescriptions and herbs through double-blind, randomized, placebo-controlled methods, clinic research and so on.

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A Study on the Effects of Topical Anesthesia to Pressure Pain Threshold of the Masticatory and Cervical Muscles (표면마취가 저작근 및 경부군의 압력통각역치에 끼치는 영향에 관한 연구)

  • Shin, Min
    • Journal of Oral Medicine and Pain
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    • v.22 no.1
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    • pp.183-192
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    • 1997
  • Pressure pain thresholds are routinely used in orofacial pain research to evaluate the response of deep orofacial tissues to mechanical stimulation. Like other psychophysical measurements, however, this technique must stimulate cutaneous tissues before stimulating deeper tissues. This study aimed at evaluating the influence of the cutaneous hypoesthesia on the pressure pain threshold in 30 healthy volunteers. PPTs were determined with electric pressure algometry over masseter, temporalis anterior, sternocleidomastoid, and trapezius muscle before and after skin hypoesthesia. A local anesthetic cream and a control cream were applied following a placebo-controlled double-blind design and PPTs were reassessed. Two examiners measured PPTs two times on each muscles, randomly. And the EMG activity of all muscles were measured to evaluate the relationship with PPTs. The collected data were processed by SAS/STAT program. The obtained results were as follows : 1. There were a tendency to increase PPTs after than before cutaneous hypoesthesia, but, there were no significant difference statistically. 2. PPTs were consistently higher in anterior temporalis than in masseter muscle. 3. In all occasions, PPTs were higher in males than in females(p<0.001). 4. A statistically significant correlation was obtained from values of intra-examiners and inter-examiners in all measured muscles. 5. A significantly positive correlation was not found between PPT and functional EMG activity.

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