• Title/Summary/Keyword: randomized controlled double blind study

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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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Effect of Mahuang on Heart Rate Variability in Adults : a Double-Blind, Placebo-Controlled, Randomized Trial (마황 복용이 정산인의 심박변이도에 미치는 영향에 대한 무작위배정 이중맹검 임상연구)

  • Son, Dong-Hyuk;Hsing, Li-Chang;Kim, Lak-Hyung;Jeong, Seung-Il;Seo, Eui-Seok;Jang, In-Soo
    • The Journal of Korean Medicine
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    • v.28 no.1 s.69
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    • pp.105-116
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    • 2007
  • Objectives : Mahuang (Ephedra sinica), well known as an herbal medicine in the East and West, contains a relatively high percentage of ephedrine known as sympathomimetic alkaloid. We investigated the effects of Mahuang on sympathetic nervous system with heart rate variety (HRV). Time and frequency domain analysis of HRV is a noninvasive technique capable of providing information on autonomic modulation of the sinus node. Methods : We investigated 57 healthy volunteers consisting of 37 subjects in the Mahuang group and 20 subjects in the placebo group. Study form was a randomized, placebo-controlled, double-blind clinical trial. The 37 subjects in the Mahuang group took 3 Mahuang capsules (1 capsule equivalent to 2g herb Mahuang) twice a day at 10 a.m. and 2 p.,., while the 20 subjects in the placebo group took 3 placebo-capsules filled with glutinous rice powder at the same times. Mahuang medicine and placebo medicine were made into opaque capsules. We measured HRV at 3 p.m. 1 or 2 days before medication and at 3 p.m. after medication. Results : Mean-RR and SDNN of the Mahuang group significantly decreased compared with that of the placebo group, but the heart rate of the Mahuang group significantly increased compared with the placebo. HRV-Index, RMSSD and SDSD of the Mahuang group significantly decreased compared with that of the placebo group, but PNN50 of the Mahuang group significantly increased compared with placebo. Ln(TP), Ln(VLF), Ln(LF) and Ln(HF) of the Mahuang group significantly decreased compared with those of the placebo group. There were no significant differences in normalized LF, normalized HF and LF/HF ratio between the Mahuang and placebo groups. Conclusion : The results suggest that Mahuang in healthy adults tends to reduce the autonomic nervous system within the normal range.

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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.

Effect of Hominis Placenta Pharmacopuncture for a Patient with Mild Cognitive Impairment: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial

  • Kim, Yunna;Eom, Yoon Ji;Kwon, Dohyung;Lee, Jae Hyok;Jung, In Chul;Cho, Eun;Lee, Ji Eun;Cho, Seung-Hun
    • Journal of Oriental Neuropsychiatry
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    • v.32 no.2
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    • pp.81-93
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    • 2021
  • Objectives: Mild cognitive impairment (MCI) is condition of cognitive decline shown in transition from normal aging to dementia. Hominis placenta pharmacopuncture (HPP) is a treatment that combines effects of medication and acupuncture by injecting Hominis placenta into acupoints. The objective of this study was to evaluate the efficacy and safety of HPP for MCI. Methods: This was a randomized, double-blind, placebo-controlled, two-center clinical trial. Eligible patients were randomly allocated to either the HPP group or the placebo group. HPP or saline as placebo was administered to participants for eight weeks. Changes in symptoms were observed. The primary outcome was difference in mean change of Korean Version of the Montreal Cognitive Assessment (MoCA-K) score between the HPP group and the placebo group. Cognitive function, overall status of mood and sleep, and quality of life (QoL) were also assessed. Safety assessment and economic analysis were then conducted. Results: Thirty participants were enrolled. One participant in the placebo group dropped out. The score of MoCA-K increased after treatment. Its mean change was smaller in the HPP group than in the control group. HPP ameliorated Global Deterioration Scale and Korean Dementia Rating Scale subtests for attention, organization, and memory compared to the placebo. However, none of them was significantly different between the two groups. Mood, sleep, and QoL all improved more in the HPP group than in the placebo group, although differences between the two groups were not statistically significant. There was no adverse event probably related to the drug. HPP treatment needed KRW 345,000 more than the placebo group in improving Geriatric Quality of Life scale-Dementia score by one point for one year. Conclusions: Although HPP treatment did not significantly improve cognition, it changed behavioral and psychological symptoms in MCI.

A Review of Acupuncture for the Treatment of Raynaud's Disease (레이노병의 침치료에 대한 연구동향)

  • Jeon, Sang-woo;Kim, Ho;Jeong, Min-jeong;Jang, In-soo
    • The Journal of Internal Korean Medicine
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    • v.38 no.4
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    • pp.433-442
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    • 2017
  • Objectives: The purpose of this study was to assess the effectiveness of acupuncture for the treatment of Raynaud's disease. Methods: This review was conducted using nine electronic databases (CINAHL, CiNii, CNKI, EMBASE, J-STAGE, NDSL, OASIS, PubMed, and WANFANG) and the keywords "Raynaud's disease", "Raynaud disease", "acupuncture", and "needling". Only randomized controlled trials (RCTs) using acupuncture for Raynaud's disease were included, and the methodological quality of the trials was assessed using the Cochrane risk-of-bias tool. Results: After screening, six RCTs were selected among 67, and the total effective rate and peripheral blood flow were used as evaluation methods. In five studies, the total effective rate was significantly higher in the intervention group than in the control group. In three studies, peripheral blood flow was higher in the intervention group than in the control group, with two studies being statistically significant and the remaining study not being statistically significant. Conclusions: Acupuncture could be a suitable treatment without adverse effects for Raynaud's disease because it improves peripheral blood flow. However, further studies, including randomized, placebo-controlled, double-blind methods, and clear evaluation criteria are needed.

Effects of Fresh Yellow Onion Consumption on CEA, CA125 and Hepatic Enzymes in Breast Cancer Patients: A Double-Blind Randomized Controlled Clinical Trial

  • Jafarpour-Sadegh, Farnaz;Montazeri, Vahid;Adili, Ali;Esfehani, Ali;Rashidi, Mohammad-Reza;Mesgari, Mehran;Pirouzpanah, Saeed
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.17
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    • pp.7517-7522
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    • 2015
  • Onion (Allium cepa) consumption has been remarked in folk medicine which has not been noted to be administered so far as an adjunct to conventional doxorubicin-based chemotherapy in breast cancer patients. To our knowledge, this is the first study aimed to investigate the effects of consuming fresh yellow onions on hepatic enzymes and cancer specific antigens compared with a low-onion containing diet among breast cancer (BC) participants treated with doxorubicin. This parallel design randomized controlled clinical trial was conducted on 56 BC patients whose malignancy was confirmed with histopathological examination. Subjects were assigned in a stratified-random allocation into either group received body mass index dependent 100-160 g/d of onion as high onion group (HO; n=28) or 30-40 g/d small onion in low onion group (LO; n=28) for eight weeks intervention. Participants, care givers and laboratory assessor were blinded to the assignments (IRCT registry no: IRCT2012103111335N1). The compliance of participants in the analysis was appropriate (87.9%). Comparing changes throughout pre- and post-dose treatments indicated significant controls on carcinoembryonic antigen, cancer antigen-125 and alkaline phosphatase levels in the HO group (P<0.05). Our findings for the first time showed that regular onion administration could be effective for hepatic enzyme conveying adjuvant chemotherapy relevant toxicity and reducing the tumor markers in BC during doxorubicin-based chemotherapy.

Citalopram and Escitalopram for Management of Hot Flashes: A Review of Recent Clinical Trials in Humans (Citalopram과 Escitalopram의 안면홍조 증상개선효과에 대한 최근 연구 고찰)

  • Lee, Yu-Jeung
    • Korean Journal of Clinical Pharmacy
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    • v.21 no.4
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    • pp.376-382
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    • 2011
  • The results from eight clinical studies demonstrate that citalopram and escitalopram could be an effective option in the treatment of hot flashes with tolerable adverse effects. However, there are limitations in the above studies. The inclusion criteria of 2 studies reviewed in this paper was breast cancer patients, so it's hard to apply the results to the general population in clinical practice. Also 4 studies had less than 50 subjects included, and the duration of study was 8 weeks or less in 7 studies reviewed in this paper. Moreover, only 4 studies were randomized, placebo-controlled trials (3 for citalopram and 1 for escitalopram). Therefore, further randomized, double-blind, placebo-controlled studies with the general population should be needed to use citalopram and escitalopram for the treatment of hot flashes in clinical practice.

Clinical and microbiological effects of egg yolk antibody against Porphyromonas gingivalis as an adjunct in the treatment of moderate to severe chronic periodontitis: a randomized placebo-controlled clinical trial

  • Xu, Yan;Selerio-Poely, Tshepiso;Ye, Xingru
    • Journal of Periodontal and Implant Science
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    • v.48 no.1
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    • pp.47-59
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    • 2018
  • Purpose: To evaluate the clinical and microbiological effects of the local use of egg yolk immunoglobulin against Porphyromonas gingivalis (anti-P.g. IgY) as an adjunct to scaling and root planing (SRP) in the treatment of moderate to severe chronic periodontitis. Methods: This was a randomized, placebo-controlled, double-blind trial involving 60 systematically healthy patients with moderate to severe chronic periodontitis. Subjects (n=20/group) were randomly assigned to receive SRP combined with subgingival irrigation of anti-P.g. IgY and anti-P.g. IgY mouthwash, subgingival irrigation of 0.2% chlorhexidine and 0.2% chlorhexidine mouthwash, or subgingival irrigation of placebo and placebo mouthwash for 4 weeks. Probing pocket depth, clinical attachment level, bleeding on probing, and the plaque index were evaluated at baseline and at 4 weeks. Subgingival plaque, gingival crevicular fluid, and saliva were simultaneously collected for microbiological analysis. Results: Our results showed that anti-P.g. IgY mouthwash was as effective as chlorhexidine at improving clinical parameters over a 4-week period. All the groups showed a significant reduction in levels of P.g. at 4 weeks. No significant difference was observed in the test group when compared to placebo regarding the reduction in the levels of P.g. Anti-P.g. IgY significantly suppressed the numbers of red complex bacteria (RCB) in subgingival plaque and saliva in comparison with placebo. No adverse effects were reported in any of the subjects. Conclusions: Within the limitations of the study, the present investigation showed that passive immunization with anti-P.g. IgY may prove to be effective in the treatment of chronic periodontitis due to its ability to improve clinical parameters and to reduce RCB. No significant differences were found between the anti-P.g. IgY and placebo groups in the reduction of P.g.

Study of the Efficacy and Safety of "adenophorae radix extract" in the Obese Patients or Overweight (비만 및 과체중 환자에 대한 사삼추출물의 유효성 및 안전성 평가)

  • Kim, Gi-Tae;Go, Heung;Shin, Seon-Mi;Kim, Hyung-Jun
    • The Journal of Korean Obstetrics and Gynecology
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    • v.25 no.2
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    • pp.131-141
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    • 2012
  • Objectives: The purpose of this study is to evaluate the efficacy and biosafety of Adenophorae Radix(AR) extract in obesity or overweight patient. Methods: This study is double-blind, randomized, placebo-controlled intervention Study. 30 patients with BMI $25{\leq}$ and 30> were allotted into two groups at random. In 0, $6^{th}$, $12^{th}$ week, we had checked body weight, waist line, hip line, body fat and abdominal CT scan. In 0, $12^{th}$ week, we also had checked lipid metabolism and biosafety with blood test. Results: AR treatment had a significant effect on suppressing body wight gain (p<0.01) and BMI index(p<0.01). AR treatment reduced plasma TG level but we couldn't find statistical significance. AR treatment had produced no adverse reactions. Conclusions: This study shows that Adenophorae Radix(AR) extract can reduce the weight, BMI. Adenophorae Radix(AR) extract can be used in obesity or overweight patient.

Intrathecal Meperidine Plus Lidocaine for Prevention of Shivering during Cesarean Section

  • Rastegarian, Ahmad;Ghobadifar, Mohamed Amin;Kargar, Hossein;Mosallanezhad, Zahra
    • The Korean Journal of Pain
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    • v.26 no.4
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    • pp.379-386
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    • 2013
  • Background: Shivering related to spinal anesthesia may interfere with monitoring and is uncomfortable. The aim of the present study was to investigate low-dose intrathecal meperidine for the prevention of shivering after induction of spinal anesthesia in parturients with cesarean section. Methods: This was a prospective randomized, double-blind, placebo-controlled trial including 100 parturients, of American Society of Anesthesiologists (ASA) physical status I or II, scheduled for elective cesarean section under spinal anesthesia who were randomly assigned to a meperidine (0.2 mg/kg) plus hyperbaric lidocaine (5%, 75 mg, n = 50; group M) group or a placebo plus hyperbaric lidocaine (5%, 75 mg, n = 50; group L) group. Demographic and surgical data, adverse events, and the mean intensity for each parturient were assessed during the entire study period by a blinded observer. Results: There were no significant differences between the two study groups regarding the demographic and surgical data (P > 0.05). The incidence of shivering during the entire study period significantly decreased in the group of parturients who received intrathecal meperidine (P = 0.04). There were no significant differences in nausea and vomiting between the two groups. Conclusions: Low-dose intrathecal meperidine (10 mg) is safe and effective in reducing the incidence and severity of shivering associated with spinal anesthesia in parturients with cesarean section.