• 제목/요약/키워드: Double blind test

Search Result 144, Processing Time 0.165 seconds

The Verify of Memory Improvement by Gastrodia Elata Blume Depends on the Amount (천마의 용량에 따른 기억력 향상 효과에 대한 연구)

  • Kim, Ha-Na;Kim, Ji-Eun;Jeong, Jong-Kil;Kim, Jeong-Sang;Kim, Kyeong-Ok
    • Journal of Oriental Neuropsychiatry
    • /
    • v.25 no.3
    • /
    • pp.243-252
    • /
    • 2014
  • Objectives: This study was designed to investigate the dose-dependent effects of Gastrodia elata Blume for memory improvement. Methods: This study was a 12-weeks, double blind, and comparative clinical study. Those who were eligible worked with a group of healthy seniors, all 60 years of age or older. 22 subjects were randomized either to Gastrodia elata Blume powder form that was steeped in hot water or placebo. We measured the faculty of memory by using MMSE-K, Digit Span, Letter Fluency Test, Word List Memory Test, and Trail Making Test, and again after 12 weeks. Results: 1) Neither Gastrodia elata Blume groups nor control have a difference in MMSE-K, Digit Span, Letter Fluency Test, and Trail Making Test. 2) Gastrodia elata Blume group showed significant advances in immediate recall 1 and 2 of Word List Memory Test, and 3 g group show better results than the 4 g group. 3) 4 g Gastrodia elata Blume group showed significant advances in the recognition of Word List Memory Test. Conclusions: The results suggest that positive effects on memory improvement due to Gastrodia elata Blume depend on the amount.

Antihypertensive Effect and Safety Evaluation of Vegetable Drink with Peptides Derived from Sardine Protein Hydrolysates on Mild Hypertensive, High-normal and Normal Blood Pressure Subjects (정어리 단백질 유래 펩티드를 배합한 야채 과일 음료의 경증 고혈압자, 정상고치(高値)혈압자 및 정상혈압자에 대한 강압효과와 안전성의 평가)

  • Kawasaki, Terukazu;Chen, Jian-Jun;Fukushima, Yoichi;Kegai, Kaori;Seki, Eiji;Osajima, Katsuhiro;Itoh, Kazue;Matsui, Toshiro;Matsumoro, Kiyoshi
    • Proceedings of the Korean Society of Food Hygiene and Safety Conference
    • /
    • 2004.11a
    • /
    • pp.59-70
    • /
    • 2004
  • A randomized double-blind placebo-controlled study was conducted on 63 subjects to determine the antihypertensive effect of a vegetable drink in which sardine protein hydrolysates containing a dipeptide, Valyl-Tyrosine (VY), were incorporated. The subjects, consisting of people with mild hypertension, high-normal blood pressure and normal blood pressure, were randomly divided into test (male/female=25.6, average age 50.1${\pm}$10.4 years old) and control groups (26/6, 49.0${\pm}$5.0). Each subjects in the test group was given 195g of the vegetable drink containing 0.5g of sardine peptides (sardine protein hydrolysates) with 0.4 mg of VY (test drink) once a day for 13 weeks in a row, and subjects in the control group were given the same amount of the vegetable drink without sardine peptides (control drink) in the same manner. In the test group, 40 subjects with mild hypertension of high-normal blood pressure (130 mmHg${\leq}$systolic blood pressure (SBP)<160 mmHg and/or 80 mmHg${\leq}$diastolic blood the start of the test to 134.4${\pm}$11.1 mmHg during the first week of the test period, after which similar values were seen throughout the test period (13 weeks). Compared to the control group, the difference in SBP from vaseline was statistically significant in the test group throughout the intake period. DBP also decreased significantly from 88.0${\pm}$7.9 mmHg at baseline to 83.5${\pm}$8.6 mmHg after 13 weeks. In the control group, SBP and DBP were 140.8${\pm}$8.4 mmHg and 90.5${\pm}$6.6 mmHg respectively at the start of the test, and neither decreased during the test period. In subjects with normal blood pressure, neither those in the test group nor those in the control group showed a significant change in SBP and DBP during the test period. An excessive ingestion test was performed on 25 subjects with hypertension, mild hypertension, high-normal blood pressure, and normal blood pressure by giving 585g (3 times the recommended amount of intake) of the test drink for 14 days in a row. As a result, a significant decrease of blood pressure was observed in the hypertension, mild hypertension and high-normal blood pressure groups, but no excessive decline in blood pressure or any side-effects were associated with any subjects during the test period. In the groups with normal blood pressure, the excessive ingestion of the test drink did not affect blood pressure. In these two studies, physical check-ups and biochemical analyses of blood and urine were also conducted in all subjects, and no abnormalities were observed. These results suggest that the test drink containing sardine protein hydrolysates exhibited the antihypertensive effect in only the subjects with mild hypertension or high-normal blood pressure. No adverse effects were observed in either hypertensive of normotensive subjects.

  • PDF

Effects of Korean Red Ginseng on Cognitive and Motor Function: A Double-blind, Randomized, Placebo-controlled Trial

  • Yeo, Hye-Bin;Yoon, Ho-Kyoung;Lee, Heon-Jeong;Kang, Seung-Gul;Jung, Ki-Young;Kim, Leen
    • Journal of Ginseng Research
    • /
    • v.36 no.2
    • /
    • pp.190-197
    • /
    • 2012
  • Ginseng has a long history of use for health enhancement, and there is some evidence from animal studies that it has a beneficial effect on cognitive performance. The purpose of this study was to investigate the effect of Korean red ginseng on cognitive performance in humans. A total of 15 healthy young males with no psychiatric or cognitive problems were selected based on an interview with a board-certified psychiatrist. The subjects were randomly assigned to receive a daily dose of 4,500 mg red ginseng or placebo for a 2-week trial. There were 8 subjects in the red ginseng group and 7 subjects in the placebo group. All of the subjects were analyzed with the Vienna test system and a P300 event-related potential (ERP) test. There were no significant differences in the Vienna test system scores between the red ginseng group and the placebo group. In the event-related potential test, the C3 latency of the red ginseng group tended to decrease during the study period (p=0.005). After 2 wk, significant decreases were observed in the P300 latencies at Cz (p=0.008), C3 (p=0.005), C4 (p=0.002), and C mean (p=0.003) in the red ginseng group. Our results suggest that the decreased latency in ERP is associated with improved cognitive function. Further studies with a higher dosage of ginseng, a larger sample size, and a longer follow-up period are necessary to confirm the clinical efficacy of Korean red ginseng.

Evaluation of the Effectiveness and Safety of Zanthoxylum piperitum Leaf Extract against Mild Degenerative Osteoarthritis of Knee: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial (경증의 퇴행성 슬관절염에 대한 초피나무잎 추출물의 유효성 및 안전성 평가: 무작위 배정, 이중맹검, 위약대조 임상연구)

  • Jeong, Ji-Hong;Lee, Soo-Hwan;Yoon, Hong-Ryoul;Kim, Soon-Joong
    • Journal of Korean Medicine Rehabilitation
    • /
    • v.31 no.4
    • /
    • pp.167-191
    • /
    • 2021
  • Objectives Degenerative osteoarthritis of knee is a disease with an increasing number of patients worldwide and its general treatments have some side effects. Methods 102 subjects were classified into test group 1, test group 2, and control group, and clinical trial products were taken for 12 weeks. The effectiveness was evaluated with changes in visual analogue scale, Korean-Western Ontario and McMaster Universities Osteoarthritis Index, inducible nitric oxide synthase, and cyclooxygenase-2. Results Both test group 1 and test group 2 were effective in reducing the pain of degenerative osteoarthritis of knee, and only test group 2 was effective in improving the ability to perform daily activities. No clinically significant changes were observed for any safety parameter. Conclusions In conclusion, the data of this study indicate that Zanthoxylum piperitum leaf extract has effectiveness and safety against mild degenerative osteoarthritis of knee.

Proficiency test for analyzing illegal compounds in food (식품 중 부정유해물질의 분석 능력평가)

  • Chang, Moonik;Yoon, Taehyung;Hong, Mooki;Choi, Dongmi
    • Analytical Science and Technology
    • /
    • v.20 no.1
    • /
    • pp.78-83
    • /
    • 2007
  • To perform proficiency test for determining anti-impotence drug-like compounds in food, interlaboratory test has been done. Targets were 6 such as sildenafil, tadalafil, vardenafil, homosildenafil, hydroxy-homosildenafil and pseudo-vardenafilI. Total 13 institutes were participated and all is in charging of food analysis. To do double blind test, the reference materials were made as 13 different ginseng drink samples and each sample had random 3 targets. By the official method for anti-impotence drug-like compounds in food code, sample was just diluted in water, extracted in organic solvents, determined by HPLC/UV and then confirmed by LC/MS. The analytical duration was 60 days after receiving sample. Ten out of 13 institutes were satisfied by evaluation of Z-score and RSZ according to the regulation for managing analytical quality assurance.

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
    • /
    • v.24 no.5
    • /
    • pp.207-217
    • /
    • 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.

  • PDF

Effects of Fiber Supplements on Functional Constipation (식이섬유의 섭취가 만성 기능성 변비에 미치는 영향)

  • Kim Ji Young;Kim Oh Yoen;Yoo Hyun Ji;Kim Tae Il;Kim Won Ho;Yoon Young Dal;Lee Jong Ho
    • Journal of Nutrition and Health
    • /
    • v.39 no.1
    • /
    • pp.35-43
    • /
    • 2006
  • This study aimed to evaluate the effect of dietary fiber supplementation with snack type on functional constipation. We conducted a double blind case-control study with 3 groups; placebo, low dose group (LD: insoluble fiber 7 g/d + soluble fiber 1.2 g/d) and high dose group (HD: insoluble fiber 14 g/d + soluble fiber 2.4 g/d) , which were randomly assigned out of subjects with functional constipation, defined by modified Rome II criteria. We measured anthropometric parameters and evaluated the bowel movement frequency, stool type, straining, sense of complete evacuation, abdominal discomfort/pain, abdominal inflation, relief and colon transit time before, during the supplementation. Both LD and HD groups had significant improvement in straining, sense of complete evacuation and satisfactory relief compared with placebo group (p < 0.05). When subdivide by baseline colon transit time (less than 24 hrs/ 24 hrs or more and less than 72 hrs / 72 hrs or more), only HD group had significantly improvement; colon transit time recovered near by 24 hrs in subjects of 'less than 24 hrs' (from $7.57{\pm}1.40$ hrs to $25.2{\pm}3.91$ hrs, p < 0.01) and reduced in those of '24hr or more and less than 72 hr' (from $47.0{\pm}3.36$ hrs to $31.3{\pm}4.31$ hrs, p < 0.01) and '72 hr or more' (from $106.7{\pm}10.7$ hrs to $85.0{\pm}13.1$ hrs, P < 0.05) subjects. Particularly, positive effect of fiber supplementation on straining and sense of complete evacuation in test groups seemed to be greater in subjects of '24 hrs or less' and '24 hrs or more and less' than 72 hrs' than those of '72 hrs or more'. In conclusion, subjects with functional constipation, particularly those having colon transit time less than 72 hrs can significantly improve, at least in part, symptom related to constipation by fiber supplementation of snack type without serious side effects.

A Clinical Trial about Anti-anxiety and Anti-stress Effect of a modified formula consisted with Several Herbs (발아현미와 수종한약재 추출액의 스트레스 및 불안상태 개선 효과에 대한 임상연구)

  • Kim Lak Hyung;Jang In Soo;Kim Jeong Yun;Song Jeong Mo
    • Journal of Physiology & Pathology in Korean Medicine
    • /
    • v.17 no.6
    • /
    • pp.1533-1537
    • /
    • 2003
  • This double-blind randomized clinical trial was performed to evaluate the anti-anxiety, anti-stress effect of a modified formula WS-01 consisted with several herbs(Jujubae Fructus. Longanae Arillus. Poria Cocos) and germinated rice. The extract of the formula was administered (p.o) to 24 students and placebo was to 23 students for 4 weeks. STAI-KYZ(Hahn. Hakjisa), ABR2000(Meridian, Korea), CBC, LFT, U/A were checked before and after the administration period. There was no difference between the STAI score of WS-01 and that of placebo group in first test. But the STAI state anxiety score was 5.33±7.33 reduced in WS-01 group and it was 0.52±6.42 increased in placebo group in second test. this result was significant stastically. 10 students in WS-01 group showed improving result, but only 1 student in placebo group showed improving result of ABR2000 test. The result of ABR2000 was analyzed with curve 2, Regulation 2, and graph 1,2,3, because those reflect central nerve system and stressful condition of the body. There was no significant result in first and second CBC, LFT, Urine test. The results of this clinical study suggest that WS-01 has anti-anxiety, anti-stress effect, and it could be applied to various conditions or disorders related with anxiety and stress.

Anesthetic efficacy and safety of 2% lidocaine hydrochloride with 1:100,000 adrenaline and 4% articaine hydrochloride with 1:100,000 adrenaline as a single buccal injection in the extraction of maxillary premolars for orthodontic purposes

  • Deshpande, Nupoor;Jadhav, Anendd;Bhola, Nitin;Gupta, Manan
    • Journal of Dental Anesthesia and Pain Medicine
    • /
    • v.20 no.4
    • /
    • pp.233-240
    • /
    • 2020
  • Background: Palatal injection of local anesthetics is the most painful injection. To obviate the need for palatal injections, local anesthetic agents with diffusibility are being investigated. Hence the present study was designed to analyze the anesthetic efficacy of 2% lidocaine hydrochloride (HCl) with 1:100,000 adrenaline and 4% articaine hydrochloride (HCl) with 1:100,000 adrenaline using single buccal infiltration for the extraction of maxillary premolars. Methods: A prospective, double-blind, crossover, randomized clinical study was performed on 60 consecutive systemically healthy patients with an age range of 15-30 years, requiring extraction of asymptomatic bilateral maxillary premolars for orthodontic purposes. They received 1ml buccal infiltration of 4% articaine HCl with 1:100,000 adrenaline on one side and 2% lidocaine HCl with 1:100,000 adrenaline on the other side. The extraction procedure on either side was scheduled 14 days apart. Parameters assessed were the time of onset of anesthesia, intraoperative discomfort, hemodynamic parameters, and the duration of analgesia. Analysis of the data was done using the Mann-Whitney test, the Wilcoxon test, the Kruskal-Wallis ANOVA test, and the chi-square test. Statistical significance was established at P < 0.05. Results: Articaine showed a faster time of onset and longer duration of analgesia than lidocaine. However, the difference in the intraoperative discomfort and hemodynamic parameters was statistically insignificant. Conclusion: Within the limitations of the study, it can be concluded that the extraction of maxillary premolars can be performed with a single buccal infiltration of 2% lidocaine HCl with 1:100,000 adrenaline, which is one of the most commonly used local anesthetic agent.

The Efficacy and Safety of Beef Tallow Extract Including Cis-9-cetylmyristoleate in Patients with Osteoarthritis - As an Adjuvant Pharmacological Treatment -

  • Lee, Sang-Hoon;Kim, June-Hyuk;Cho, Whan-Seong;Seo, Sung-Wook;Kim, Sung-Kyu;Oh, Joo-Han
    • Preventive Nutrition and Food Science
    • /
    • v.10 no.3
    • /
    • pp.285-289
    • /
    • 2005
  • In this double-blind, placebo-controlled trial, we assessed the efficacy and safety of beef tallow extract (BTE) including Cis-9-cetylmyristoleate in patients with arthritis. Between May and December 2003, we selected 80 patients (n=80) who showed/manifested arthritic symptoms and whose radiological findings were suggestive of arthritis, and randomly assigned them to placebo-controlled (n=40) and treatment group (n=40). The placebo (corn starch 350 mg) and BTE (208 mg) were orally administered to placebo-controlled and treatment group three times a day, respectively. We assessed the efficacy and safety based on the visual analogue scale (V AS) and modified knee society knee scores (MKSKS) at baseline and endpoint, respectively. To assess the safety, we monitored the adverse effects noted in liver, kidney, cardiovascular and gastrointestinal system for 3 weeks. Then, we performed not only a questionnaire study but also laboratory tests (e.g., liver function test, kidney function test, urinalysis, electrocardiography [EKG], complete blood cell counts [CBC] and chest X-ray). For statistical analysis, Student (-test and paired (-test were done using SPSS■ Version 11.0. Statistical significance was set at p < 0.05. The scores between V AS and MKSKS showed statistical significance (p < 0.05) with an improvement of $69.2\%$ (27/39) and $3.8\%$ (21/39) of treatment-group patients, respectively. Abnormal laboratory findings were noted in neither placebo-controlled nor treatment group. In conclusion, our results indicate that the administration of BTE was a safe and effective treatment regimen for patients with arthritis. In addition, the efficacy of BTE was more remarkable in alleviating the symptoms rather than improving the function.