scholarly journals Validation Study of Kim's Sham Needle by Measuring Facial Temperature: An N-of-1 Randomized Double-Blind Placebo-Controlled Clinical Trial

2012 ◽  
Vol 2012 ◽  
pp. 1-7 ◽  
Author(s):  
Sanghun Lee ◽  
Nara Lim ◽  
Sun Mi Choi ◽  
Sungchul Kim
Keyword(s):  
Thermal Imaging ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Infrared Thermal Imaging ◽  
Double Blind Placebo ◽  
Control Intervention ◽  
Significant Difference ◽  
Double Blinded ◽  
Stimulation Of

Introduction. In 2008, Kim's sham needle was developed to improve the quality of double-blinded studies. The aim of this study is to validate Kim's sham needle by measuring facial temperature.Methods. We designed “N-of-1” trials involving 7 smokers. One session was composed of 2 stimulations separated by a 2 h washout period. Six sessions were applied daily for all subjects. Infrared thermal imaging was used to examine the effects of acupuncture (HT8, KI2) on facial temperature following smoking-induced decrease.Results. All subjects demonstrated decreased temperatures after sham needle treatment, but 5 of the 7 subjects showed increased temperatures after real needle treatment. 6 of the 7 subjects showed a significant difference(P<0.05)between treatments with real and sham needles. Thus, the physiological stimulation of Kim's sham needle is different from that of a real needle, suggesting that Kim's sham needle is a potential inactive control intervention.

scholarly journals The Effects of Propolis Extract Administration on HIV Patients Receiving ARV

2021 ◽  
Vol 13 (1) ◽  
pp. 75-83
Author(s):  
Erwin Astha Triyono ◽  
Sarah Firdausa ◽  
Heru Prasetyo ◽  
Joni Susanto ◽  
James Hutagalung ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Placebo Group ◽  
Clinical Symptoms ◽  
Cd4 Count ◽  
Controlled Clinical Trial ◽  
Human Immune System ◽  
Hiv Patients ◽  
Double Blind ◽  
Significant Difference

BACKGROUND: Human immunodeficiency virus (HIV) is an infectious disease that targets the human immune system by attacking cluster of differentiation (CD)4 cells. The use of propolis in HIV patients is expected to be safe and beneficial in terms of increasing endurance and immunity by its role in increasing CD4 level. This study aimed to analyze the influence of propolis supplementation in increasing the CD4 level in anti-retroviral (ARV)-treated HIV patients.METHODS: Double-blind randomized controlled clinical trial was conducted in 50 HIV patients who took regular ARV therapy. The subjects were divided into two groups, one group was treated with ARV and propolis, while another one was given ARV and placebo. The CD4 cell count was measured during pre-treatment, in the 3rd month, in the 6th month after treatment. The level of hemoglobin, leukocyte, and platelets were also measured. The SF-12 questionnaire was used to evaluate quality of life of the subject.RESULTS: Out of 50 subjects, 43 subjects completed the study, which were 19 subjects from the propolis group and 24 subjects from the placebo group. After 3-month of treatment, there was a statistically significant difference in the incrwase of CD 44 level in propolis group, while the increment was not significant in the placebo group. After 6-month treatment, the increase of CD4 level was occurred in both groups, propolis and placebo, however the increment was not statistically significant. The levels of hemoglobin, leukocyte, and platelets were not altered by the treatment and remained normal throughout the study. The quality of life was improved during the study; however, it was also not statistically significant. Mild adverse events occurred in 3 subjects which were relieved after the treatment stopped.CONCLUSION: Based on the result of this study, the administration of propolis on HIV patients receiving ARV bring significant difference in the increase of CD4 in propolis group from baseline to 3 month after the treatment. While in placebo group, this increment was not significant. At the end of study, CD4 count continued to rise up, however the increase was not statistically significant. There are no hemoglobin, leukocyte, platelets, and quality of life abnormalities. Therefore, it is necesary to do further research with a spesific CD4 count. However, it may be beneficial in relieving the clinical symptoms and quality of life of patient living with HIV.KEYWORDS: CD4, ARV, HIV, propolis

scholarly journals Perbandingan Tingkat Sedasi Klonidin Syrup 2 mcg/kgBB dengan Diazepam Syrup 0.4 mg/kgBB sebagai Premedikasi pada Pasien Anak yang Menjalani Pembedahan dengan General Anestesi

2017 ◽  
Vol 5 (2) ◽  
pp. 111
Author(s):  
Vera Muharrami ◽  
A. Sani P. Nasution ◽  
Nazaruddin Umar
Keyword(s):  
Pediatric Surgery ◽  
Optimal Dose ◽  
Controlled Clinical Trial ◽  
Subjective Feeling ◽  
Double Blind ◽  
Adrenoceptor Agonist ◽  
Number Of Patients ◽  
Significant Difference ◽  
Preanesthetic Medication

Introduction: Anxiety in children undergoing surgery is characterized by subjective feeling of tension, apprehension,nervousness and worry that may be expressed in various forms. Clonidine, an alpha 2-adrenoceptor agonist, has beenshown to be as a preanesthetic medication in childrens. The current study was designed to investigate the differencesof level sedation clonidine syrup and diazepam syrup as a premedicant in children.Methods: In a randomized, double-blind, controlled clinical trial, 40 children, aged 2-12 yr, undergoing electivesurgery received 2 micrograms/kg clonidine syrup or 0.4 mg/kg diazepam syrup orally. These agents were administered120 min before the estimated time of induction of general anesthesia and noted the children’s level of sedation. Thelevel of sedation were compared among the two groups. PASS <1 demanded rescue intravenous sedation.Result: Clonidine syrup 2 mcg/kgBB provided better quality of sedation after 60 min of premedicant but it wasn’tsignificant(1.8±0.92) and diazepam syrup (0.80±0.89; p>0.05) and number of patients with rescue intravenous diazepamacceptance were same both clonidine group compared to diazepam, there was no significant difference between twogroups, 10% of clonidine group patients, 10 % of diazepam group patients (p>0.05). No clinically significanthypotension or bradycardia was observed after preanesthetic medications of diazepam and clonidine syrup.Discussion: These data indicate that, even in pediatric surgery, the 2 micrograms/kg syrup clonidine is an effectivepremedication. However, the safety and optimal dose of clonidine in this setting remain to be determined.

Effects of Helichrysum Psudoplicatum supplementation on pruritus intensity, fatigue, quality of life and anorexia in hemodialysis patients: a randomized, double-blind placebo-controlled trial

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Maryam Mohajeranirad ◽  
Naser Saeidi ◽  
Mohammad Kamali Nejad ◽  
Amir Almasi-Hashiani ◽  
Mehdi Salehi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Rating Scale ◽  
Controlled Trial ◽  
Intervention Group ◽  
Controlled Clinical Trial ◽  
Dialysis Patients ◽  
Time Duration ◽  
Double Blind ◽  
Double Blind Placebo

Abstract Objectives Anorexia, fatigue and pruritus are common complications of hemodialysis (HD) patients. Today, the use of medicinal plants is more than synthetic drugs due to their safety. Therefore, we designed a randomized controlled clinical trial to evaluate the effects of Helichrysum psudoplicatum (H. psudoplicatum) supplementation on biochemical parameters, pruritus intensity, fatigue, quality of life and anorexia in HD patients. Methods This randomized, double-blind, placebo-controlled trial was performed on 50 subjects with, aged 55–65 years old. HD patients were randomly divided into two groups. Intervention group received 250 mg/day of H. psudoplicatum supplement capsule for 6 weeks (n=25), and the placebo group was given placebo capsule for the same time duration and dosage (n=25). The serum concentrations of urea, creatinine, albumin and hemoglobin were measured enzymatically methods. Anorexia, pruritus intensity, quality of life the dialysis patients with pruritus and fatigue score was measured using a Simplified Nutritional Appetite Questionnaire (SNAQ), Numerical rating scale (NRS), Fatigue severity scale (FSS) and ItchyQoL questionnaire, respectively. Shapiro–Wilk and independent-samples t-test or Mann–Whitney test were used for the analysis of the data. Results The results showed that the H. psudoplicatum supplementation significantly improved the pruritus intensity, quality of life the dialysis patients with pruritus and fatigue in HD patients, for 6 weeks (p<0.001). However, it did not significantly effect on the anorexia, albumin, hemoglobin, urea, creatinine, arm circumference, and body mass index (p>0.05). Conclusions According to the results of this study, H. psudoplicatum supplementation can be effective as an adjunct therapy to improve pruritus intensity, quality of life, fatigue and relative improvement of anorexia in HD patients.

Riluzole for treatment of men with methamphetamine dependence: A randomized, double-blind, placebo-controlled clinical trial

2018 ◽  
Vol 33 (3) ◽  
pp. 305-315 ◽  
Author(s):  
Mohammad-Hadi Farahzadi ◽  
Ehsan Moazen-Zadeh ◽  
Emran Razaghi ◽  
Mohammad-Reza Zarrindast ◽  
Reza Bidaki ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trials ◽  
Specific Treatment ◽  
Controlled Clinical Trial ◽  
P Value ◽  
Urine Test ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Methamphetamine Dependence ◽  
Significant Difference

Background: Riluzole is a glutamate regulator and effective in treatment of neuropsychiatric conditions. Aims: We assessed riluzole for treatment of methamphetamine dependence. Methods: In this randomized, double-blind, placebo-controlled clinical trial, male outpatients with methamphetamine dependence who were 18–65 years old received either 50 mg riluzole ( n=34) or placebo ( n=54) twice daily for 12 weeks. Patients were excluded in case of comorbid serious medical conditions or neurologic disorders, comorbid psychiatric disorders other than methamphetamine dependence requiring specific treatment interventions, simultaneous positive urine test result for substances of abuse other than methamphetamine, smoking >3 days per week, simultaneous consumption of medications which are contraindicated or have interaction with riluzole. Results: Concerning primary outcomes, the cumulative mean number of attended weekly visits was higher in the riluzole arm compared with the placebo arm approaching a statistically significant difference (riluzole, median (range)=13.00 (2.00–13.00); placebo=4.00 (2.00–13.00); Mann-Whitney U=505.00, p-value=0.073), and the weekly measured rate of positive methamphetamine urine test results was significantly lower in the riluzole arm by the end of the study (riluzole=1 (5.00%), placebo=9 (45.00%), p-value=0.004). Patients in the riluzole arm experienced significantly greater improvement on all the craving, withdrawal, and depression measures regarding mean score changes from baseline to endpoint. No significant difference was detected between the two arms in terms of incidence of adverse events. Conclusion: Future randomized clinical trials are needed to investigate proper dosing strategy in a more inclusive sample.

scholarly journals A novel botanical formula improves eye fatigue and dry eye: a randomized, double-blind, placebo-controlled study

2020 ◽  
Vol 112 (2) ◽  
pp. 334-342 ◽  
Author(s):  
Juntao Kan ◽  
Min Wang ◽  
Ying Liu ◽  
Hongyue Liu ◽  
Liang Chen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Dry Eye ◽  
Controlled Study ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Eye Fatigue ◽  
Nutritional Strategy ◽  
Significant Difference ◽  
Break Up

ABSTRACT Background With the frequent use of video display units, eye fatigue is becoming more common globally. An alternative nutritional strategy is needed to prevent the aggravation of eye fatigue symptoms. Objectives The objective was to evaluate the protective effect of a novel botanical combination of lutein ester, zeaxanthin, and extracts of blackcurrant, chrysanthemum, and goji berry on adults with eye fatigue in a randomized, double-blind, placebo-controlled clinical trial. Methods We randomly allocated 360 participants into 4 groups to receive placebo and 3 doses of our formula (chewable tablets, containing 6 mg, 10 mg, or 14 mg of lutein) once daily for 90 d. Each participant had 3 visits at baseline (V1), 45 d (V2), and 90 d (V3) during the study. Results Intervention with the formula improved individual scores of eye fatigue symptoms, including eye soreness, blurred vision, dry eye, foreign body sensation, and tearing. Compared with placebo, the formula at all 3 doses significantly decreased the total score of eye fatigue symptoms and increased the visuognosis persistence time at both V2 and V3. According to the Schirmer test, both 10-mg and 14-mg lutein formula groups had improved tear secretion at V3 compared with the placebo. The keratography results indicated that the first tear break-up time, average tear break-up time, and tear meniscus height were significantly increased after formula intervention. The formula at all 3 doses significantly increased the macular pigment optical density at V2 and V3 compared with the placebo, whereas optical coherence tomography showed no significant difference in retinal thickness and retinal volume across all groups at both visits. Conclusions Our botanical formula improves eye fatigue, dry eye, and macular function without changing the retinal structure, and thus it could serve as an effective nutritional strategy in improving eye fatigue without causing serious side effects. Clinical Trial Registry: chictr.org.cn (ChiCTR1800018987).

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