• 제목/요약/키워드: Placebo-controlled study

검색결과 353건 처리시간 0.018초

A Double-Blind, Placebo Controlled-Trial of a Probiotic Strain Lactobacillus sakei Probio-65 for the Prevention of Canine Atopic Dermatitis

  • Kim, Hyejin;Rather, Irfan A.;Kim, Hyunwook;Kim, Sungsoo;Kim, Taeeun;Jang, Jaeyoung;Seo, Jimin;Lim, Jeongheui;Park, Yong-Ha
    • Journal of Microbiology and Biotechnology
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    • 제25권11호
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    • pp.1966-1969
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    • 2015
  • Canine atopic dermatitis (CAD) is a ubiquitous, chronic inflammatory skin disorder prevalent in dogs, which results in production of abnormal levels of IgE antibodies in reciprocation to an allergen challenge. In this study, administration of the probiotic strain Lactobacillus sakei probio-65 for 2 months significantly reduced the disease severity index in experimental dogs diagnosed with CAD. In addition, one month pre-medication of L. sakei probio-65 revealed significant difference in the PVAS score in experimental dogs for both probio-65 and placebo groups. However, post 2 months treatment resulted in a significant decrease in the CASESI score values in the probio-65-treated group (p < .0.06).

비타민 K2(Menaquinone-7) 함유 청국장 분말의 섭취가 폐경기 여성의 뼈건강 개선에 미치는 효과 (Effect of Vitamin K2 (Menaquinone-7) in Cheongukjang Powder on Bone Health Circulation in Postmenopausal Women)

  • 방선옥;김금숙;정민홍
    • 한국식품영양학회지
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    • 제29권6호
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    • pp.978-984
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    • 2016
  • Osteoporosis is a disease that often occurs in postmenopausal women. The purpose of this study was to examine the positive effects of Cheongukjang powder containing menaquinone-7 (MK-7) on bone health circulation in postmenopausal women. Fifty-six postmenopausal women were recruited into a randomised double-blind placebo-controlled trial. The participants were randomly assigned into two groups. For 12 weeks, one group received $800{\mu}g$ MK-7 in the form of Cheongukjang packs (CMK-7), and the other group received the same amount of identical-looking placebo packs containing barley meal for 12 weeks. Femoral bone mineral density (BMD), bone-specific alkaline phosphatase (ALP), deoxypyridinoline (DPD), osteocalcin (OSC), serum Ca, and serum P were measured at baseline (0 weeks) and 12 weeks. After 12 weeks in the CMK-7 group, it was found that BMD, serum Ca, and serum P had increased above the baseline (p<0.0001, p=0.0028, p<0.0001), whereas bone-specific ALP, DPD, and OSC had decreased below the baseline (p=0.0003, p<0.0001, p<0.0001). Therefore, MK-7 taken as Cheongukjang is expected to prevent osteoporosis in postmenopausal women.

Evaluating the effects of probiotics in pediatrics with recurrent abdominal pain

  • Rahmani, Parisa;Ghouran-Orimi, Azin;Motamed, Farzaneh;Moradzadeh, Alireza
    • Clinical and Experimental Pediatrics
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    • 제63권12호
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    • pp.485-490
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    • 2020
  • Background: Recurrent abdominal pain (RAP) is one of the frequent complaints in general practice, particularly in pediatrics and is among the common cause of referral to gastroenterology clinics. Purpose: This study is designed to investigate the effects of probiotics for the treatment of RAP and desired therapeutic outcomes. Methods: One hundred twenty-five children with the diagnosis of RAP according to Rome III criteria for irritable bowel syndrome (IBS), functional abdominal pain (FAP), functional dyspepsia (FD), and abdominal migraine (AM), were enrolled in this double-blind randomized controlled trial. Results: Sixty-five subjects received probiotics, and others received placebo treatment for 4 weeks. Lactobacillus reuteri was therapeutically effective in 32 patients compared to 8 patients, responding to the placebo treatment. Compared to baseline, all pain-related variables showed a significant reduction for the IBS and FD at the end of the 4th week. However, it did not respond well in FAP and AM groups. Pain-related outcomes such as, frequency of the pain, severity, and duration of the pain were decreased following the probiotic treatment. No therapeutic response was seen in AM group after the administration of probiotics. L. reuteri significantly led to pain relief in the overall population, and also in FAP, FD, and IBS subgroups. Conclusion: L. reuteri probiotics are likely to lead to RAP relief and can be recommended for the treatment of functional gastrointestinal disorders.

Pre-emptive analgesia efficacy of piroxicam versus tramadol in oral surgery

  • Tejdeep, Muthuluri;Siddardha Gowtam, Chandrupatla;Ritesh, Rajan;Viveka V., Reddy;Dinesh K., Jhawar;Abhinand, Potturi
    • Journal of Dental Anesthesia and Pain Medicine
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    • 제22권6호
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    • pp.443-450
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    • 2022
  • Background: This double-blind randomized controlled trial (RCT) was conducted to evaluate the pre-emptive analgesia and anti-inflammatory efficacy of piroxicam compared with tramadol in patients undergoing oral surgery. Methods: Seventy-eight patients who required extraction of impacted mandibular third molars were randomized into three treatment groups of 26 patients each: group I received 100 mg of tramadol, group II received 20 mg of piroxicam, and group III received a placebo. Drugs were administered intramuscularly 30 min prior to the extraction procedure. Results: Pain intensity, time to first analgesic administration, total analgesic consumption, facial edema, and trismus were the outcomes of interest. The group receiving 20 mg of piroxicam showed significantly lower pain intensity, increased time to first analgesic, and reduced edema from preoperative to postoperative day seven than those in the tramadol and placebo groups. Conclusion: The findings of this study showed that piroxicam had significant pain relief efficacy after third molar surgery compared with that in tramadol.

Attenuation of p-dimethylaminoazobenzene initiated genotoxicity and cytotoxicity in mice by the combined treatment of a traditional homeopathic remedy Chelidonium Majus 200C and vitamin-C

  • Biswas, Surjyo Jyoti;Karmakar, Susanta Roy;Khuda-Bukhsh, Anisur Rahman
    • 셀메드
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    • 제2권4호
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    • pp.35.1-35.11
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    • 2012
  • The homeopathic remedy Chelidonium majus 200C (Chel-200) is traditionally used by homeopathic practitioners in liver ailments arising out of hepatotoxicity. The present investigation was aimed at examining whether vitamin C (L-ascorbic acid or AA), used in both traditional and orthodox medicines, can show better effects when used in combination with Chel-200, in favorably modifying the toxicological effects induced by the chronic feeding of p-dimethylaminoazobenzene (p-DAB, initiator) and phenobarbital (PB, promoter) in mice for 7 days through 120 days to induce hepatotoxicity and liver tumors. Mice were euthanized at 7, 15, 30, 60, 90, and 120 days of carcinogen feeding to assess various cytogenetical, biochemical and histological changes occurring in them. In a placebo controlled study, Chel-200 or the respective placebo (Alcohol-200C or Alc, "vehicle" of homeopathic drug), was orally administered to toxicant-fed mice. Sub-groups of the mice receiving Chel-200 were also fed either AA or an Alc placebo and their individual and conjoint effects were studied against the respective controls, to evaluate if the combination therapy of Chel-200 with AA can be of additional help in the amelioration of the toxicities generated by the toxicants. The combined feeding of Chel-200 and AA appeared to reduce the cytotoxic and genotoxic effects significantly, when compared to either only the Chel-200 or AA fed group. A similar trend was also obtained in the results of scanning and transmission electron microscopic studies of the livers. Experiments in other mammalian models are warranted to confirm if these drugs in combination could be used in palliative care of human patients with liver diseases including cancer.

Effects of Korean Red Ginseng on Dry Mouth: A Randomized, Double-Blind, Placebo-Controlled Trial

  • Park, Jae-Woo;Lee, Beom-Joon;Bu, Young-Min;Yeo, In-Kwon;Kim, Jin-Sung;Ryu, Bong-Ha
    • Journal of Ginseng Research
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    • 제34권3호
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    • pp.183-191
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    • 2010
  • Dry mouth is easily neglected if not associated with oral diseases. Consequently, xerostomatic patients often use unconventional therapies. In traditional Korean medicine, Korean red ginseng (KRG) has long been used to relieve dry mouth. However, no clinical trials have investigated whether KRG actually has an effect on dry mouth. This study was performed to evaluate the efficacy of KRG for dry mouth. We enrolled 100 volunteers with no obvious oral or salivary gland diseases and divided them into KRG and placebo groups. Each group was divided into six subgroups according to age and gender. The subjects received 6 g/day of KRG or placebo for 8 weeks. The dry mouth visual analog scale (VAS), salivary flow rate, and a dry mouth-related symptom questionnaire were evaluated at baseline and at 4 and 8 weeks. KRG treatment did not show any significant differences for any of the variables. However, KRG improved the dry mouth VAS at 4 weeks and dry mouthrelated symptoms at 8 weeks in women, but not in men. Subgroup analyses revealed that KRG markedly improved the dry mouth VAS in women of menopausal age (40 to 59 years) at 4 and 8 weeks. KRG may have beneficial effects for dry mouth in women, especially those of menopausal age, but not in men. Further investigation in post- and perimenopausal women is required to elaborate on these findings.

Effect of a 5% naproxen patch on reducing pain caused by separators prior to fixed orthodontic treatment

  • Eslamian, Ladan;Rad, Nazila Akbarian;Nobar, Behnam Rahbani;Mortazavi, Seyed Alireza
    • Journal of Dental Anesthesia and Pain Medicine
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    • 제18권3호
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    • pp.151-159
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    • 2018
  • Background: The pain involved in orthodontic treatments may involve inflammatory processes. This study evaluated the effect of using a naproxen patch for pain reduction in the separating stage of fixed orthodontic treatment. Methods: In this double-blind, randomized, controlled clinical trial of 35 orthodontic patients (age: 14-19 years) who had pain during separator placement, each patient randomly placed naproxen and placebo patches in the first permanent molar region, in opposite quadrants of the same jaw. Patches were replaced every 8 hours until 3 days after separator placement. Patients recorded their pain perception at 2, 6, and 24 hours, and on days 2 (6 PM), 3 (10 AM and 6 PM), and 7 (10 AM and 6 PM), using a visual analog scale. Mean pain scores were compared for the two patches, and effects of sex and age thereon determined. Results: Data from 29 patients (21 girls, eight boys) were analyzed. Mean pain values decreased over time for both patches (P < 0.001). Recorded pain did not differ significantly between the sexes (P = 0.059) or between those aged <16 and those ${\geq}16years$ (P = 0.106). Mean pain recorded with naproxen patches was statistically significantly less than that with placebo patches at all time points (P = 0.004). Conclusion: The naproxen patch was more efficient than the placebo patch for reducing pain at all time points. The highest pain score was recorded at 6 hours, and the least pain was recorded at the $7^{th}$ day after separator placement.

알레르기 비염 질환자를 대상으로 한 더덕(Codonopsis lanceolata (S. et Z.) Trautv.) 추출물의 과민면역반응 개선에 대한 유효성 및 안전성 평가 (Efficacy and Safety of Codonopsis lanceolata (S. et Z.) Trautv. Extract on the Improvement of the Hypersensitivity Reaction in Allergic Rhinitis Patients)

  • 안하영;부희옥;김형준
    • 대한본초학회지
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    • 제34권1호
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    • pp.13-21
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    • 2019
  • Objectives : This clinical trial is performed to investigate the effect of improving the hypersensitivity reaction and the safety of powdered ethanol extract Codonopsis lanceolata (S. et Z.) Trautv. for allergic patients. Methods : This study was randomized, double blinded, placebo-controlled clinical trial. 60 allergic rhinitis subjects were randomly assigned to Treatment group(n=30) and Control group(n=30). They were received the test substance or placebo in their $1^{st}$ and $2^{nd}$ visit, and took it once a day, 1 powder bag per 1 time, for 8 weeks. The freeze dried powder of Codonopsis lanceolata (S. et Z.) Trautv. was mixed with 30% ethanol and the filtrate was collected thrice with constant stirring of the mixture. The placebo was prepared in the same form as the test substance by replacing with corn starch. Total Nasal Symptom Score(TNSS) questionnaires and laboratory tests were performed at the screening and last visit to evaluate the efficacy. And to assess safety, vital signs and adverse events were confirmed at every visit. Statistical analysis about the result was performed using SAS 9.4. Results : In treatment group, there was a significant decrease in B cell after taking the test substance(p<0.005). And there was a statistically significant difference between groups(p<0.005). Changes in nasal symptoms were not statistically significant between groups, and both groups showed statistically significant differences before and after the test(p<0.0001). Also there were no adverse events associated with the clinical trial product. Conclusions : This clinical trial showed that Codonopsis lanceolata (S. et Z.) Trautv. extract was helpful in improving the hypersensitivity reaction in allergic patients without significant side effects.

화병에 대한 사암침 심포정격의 치료 효과 : 환자-평가자 눈가림, 무작위배정 대조군 임상시험 (The effects of Sa-am Acupuncture Simpojeongkyeok Treatment on Hwa-byung : Randomized, patient-assessor blind, placebo-controlled acupuncture, pilot clinical trial)

  • 최우진;이승기;손인봉;선승호
    • 동의신경정신과학회지
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    • 제22권2호
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    • pp.1-13
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    • 2011
  • Objectives : The purpose of this research is to examine the effects of Sa-am acupuncture Simpojeongkyeok treatment on Hwa-byung. Methods : The study was performed through a patient-assessor blind, randomized, placebo-controlled trial in which the volunteers, data collector and analyst were unaware of individuals which were receiving the treatment. Fifty volunteers were divided into a trial and a control group, each of which consisted of 25 subjects. The trial group was treated with Sa-am acupuncture Simpojeongkyeok, while needle insertion at non-acupoints was given to the control group. The Likert scale for major symptoms of Hwa-byung was measured as the 1st evaluative instrument, and then a comparative analysis was conducted by comparing the results with those measured by of STAXI-K, STAI-K and BDI-K. Results : In the Likert scale comparison of major symptoms, total scores in both groups were decreased after treatment. However, a more significant decrease was found in those of trial group compared to those of the control group from a statistical perspective. The results measured by BDI scores also decreased significantly in the trial group after treatment. In comparison of STAXI and STAI scores, there were no significant differences found between the groups. Conclusions : The results suggest that Sa-am Acupuncture Simpojeongkyeok treatment is effective in the treatment of Hwa-byung.

가짜뜸 개발 및 Masking test (A sham moxibustion device and Masking test)

  • 박지은;한창현;강경원;신미숙;오달석;최선미
    • 한국한의학연구원논문집
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    • 제13권1호통권19호
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    • pp.93-100
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    • 2007
  • TObjectives: Develop a sham moxibustion and determine whether subjects can distinguish a sham moxibustion from a real moxibustion. Design: Single-blinded, randomized, placebo-controlled clinical trial Methods: Sham and real moxibustion resemble each other in appearance, burning procedure, but the base of the sham moxibustion isolates the moxa-producing heat and smoke. This device was tested in a clinical trial in which subjects received moxibustion at Zhongwan(CV12), Mingmen(GV4), Quchi(LI11), Zusanli(ST36), Taichong(LR3)), Hegu(LI4). Volunteers(n=32) were given pre-treatment questionnaire to assess their experience in getting moxibustion therapy and performing it. They randomized into treatment(n=16) or sham controlled group(n=16), received moxibustion according their groups. After treatments, the effectiveness of blinding was assessed. Results: There were no significant differences between two groups in sex, age, moxibustion experience. In the treatment group and the sham group, the number of subjects who believed they received real moxibustion or sham is not different significantly.(P=.668) The consistency of a moxibustion type which subjects received actually and the their guess about that, isn't different significantly in two groups.(P=.465) Conclusion: The sham moxibustion was successfully validated in this study, The results demonstrate that this sham moxibustion blinds subjects and can be used as effective placebo-control in moxibustion clinical trials.

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