The Effect of Nanocurcumin in Improvement of Knee Osteoarthritis: A Randomized Clinical Trial

2020 ◽  
Vol 16 (2) ◽  
pp. 158-164
Author(s):  
Kamila Hashemzadeh ◽  
Najmeh Davoudian ◽  
Mahmoud R. Jaafari ◽  
Zahra Mirfeizi
Keyword(s):  
Placebo Group ◽  
Knee Osteoarthritis ◽  
Controlled Trial ◽  
Intervention Group ◽  
Final Analysis ◽  
Control Group ◽  
P Value ◽  
Antiinflammatory Drugs ◽  
Double Blind ◽  
Womac Questionnaire

Objective: Osteoarthritis is a degenerative disease of the joints. Non-steroidal antiinflammatory drugs (NSAIDs) are being used for the treatment of osteoarthritis. However, their use is limited due to complications, such as gastrointestinal bleeding. Therefore, it is necessary to find alternative treatments for osteoarthritis. Recently, nanomicelle curcumin has been developed to increase the oral bioavailability of curcumin. The aim of this study was to evaluate the effect of nano curcumin on the alleviation of the symptoms of knee osteoarthritis patients. Methods: In this randomized, double-blind controlled trial, the intervention group was administered 40 mg of nanocurcumin capsule every 12 hours over a period of six weeks, and the control group received the placebo (similar components of nanomicelle curcumin capsules yet without curcumin). In the final analysis, 36 patients in the nanocurcumin group and 35 patients in the placebo group were enrolled. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was filled for patients in their first visit and at the end of six weeks. Differences were statistically significant at P-value < 0.05. Results: There were no significant differences between the two groups regarding gender, age, Kellgren score, and the duration of the disease before the intervention. A significant decrease was observed in the overall score, along with the scores of pain, stiffness and physical activity subscales of the WOMAC questionnaire in patients of the nano curcumin group compared with the placebo group. Conclusion: Nanocurcumin significantly improves the symptoms of osteoarthritis patients.

scholarly journals The effectiveness of Kinesio Taping® for mobility and functioning improvement in knee osteoarthritis: a randomized, double-blind, controlled trial

2020 ◽  
Vol 34 (7) ◽  
pp. 877-889 ◽  
Author(s):  
Venta Donec ◽  
Raimondas Kubilius
Keyword(s):  
Knee Osteoarthritis ◽  
Controlled Trial ◽  
Intervention Group ◽  
Outpatient Rehabilitation ◽  
Control Group ◽  
Double Blind ◽  
Kinesio Taping ◽  
Patient Reported ◽  
Double Blinded

Objective: To evaluate the effectiveness of the Kinesio Taping® method for mobility and functioning improvement for patients with knee osteoarthritis (KO). Design: Randomized, double-blinded, controlled trial. Setting: Outpatient rehabilitation department. Subjects: A total of 187 subjects with symptomatic I–III grade KO participated; of these, 157 subjects were included in the analyses (intervention group, n = 81 (123 knees); control group, n = 76 (114 knees). Intervention: The intervention group received a specific Kinesio Taping application, and the control group received non-specific knee taping for a month. Main measures: Changes in Knee injury and Osteoarthritis Outcome Scores (KOOS), knee active range of motion, 10-Meter Walk, and the five times sit to stand tests (5xSST) were assessed at baseline, after four weeks of taping, and a month post taping intervention. Subjective participants’ experiences and opinions on the effect of knee taping were evaluated. The chosen level of significance was p < 0.05. Results: The mean age of participants was 68.7 ± 9.9 in intervention group and 70.6 ± 8.3 in control group ( p > 0.05). The change from baseline in gait speed in the intervention group after taping month was +0.04 ± 0.1 m/s, at follow-up +0.06 ± 0.1 m/s; in control group +0.07 ± 0.1 m/s, and +0.09 ± 0.1 m/s; the change in time needed to accomplish 5xSST was –2.2 ± 3.2 seconds, at follow-up –2.4 ± 3.1 seconds; in control group –2.8 ± 3.6 seconds, and –2.4 ± 4 seconds. Improved knee flexion and enhancement in functioning assessed by KOOS were noticed in both groups, with lasting improvement to follow up. No difference in the change in the above-mentioned outcomes was found between groups ( p > 0.05). Fewer subjects (6.2% (5) vs. 21.1% (16), χ2 = 7.5, df = 2, p = 0.024) from Kinesio Taping group were unsure if taping alleviated their mobility and more intervention group patients indicated higher subjective satisfaction with the effect of knee taping to symptom and mobility alleviation than control group ( p < 0.005). Conclusion: Investigated Kinesio Taping technique did not produce better results in mobility and functioning improvement over non-specific knee taping; however, it had higher patient-reported subjective value for symptom attenuation and experienced mobility enhancement.

scholarly journals Efficacy and safety of celecoxib combined with JOINS in the treatment of degenerative knee osteoarthritis: study protocol of a randomized controlled trial

2021 ◽  
Vol 13 ◽  
pp. 1759720X2110240
Author(s):  
Man Soo Kim ◽  
In Jun Koh ◽  
Yong Gyu Sung ◽  
Dong Chul Park ◽  
Sung Cheol Yang ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Therapeutic Effect ◽  
Combination Treatment ◽  
Short Form ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Double Blind ◽  
Knee Oa ◽  
Anti Inflammatory

Background: The aim of this study will be to investigate the therapeutic effect and safety of non-steroidal anti-inflammatory drugs (NSAIDs) along with symptomatic slow-acting drugs for the treatment of osteoarthritis (SYSADOA), JOINS tablets, for degenerative knee osteoarthritis (OA) treatment and to determine the analgesic and anti-inflammatory effects of the combination therapy. In addition, we will investigate whether JOINS treatment alone after NSAID and JOINS combination treatment is effective in relieving and maintaining knee OA symptoms. Methods: This study will be a prospective, randomized, double-blind endpoint study design. All patients will be randomly assigned to either intervention (celecoxib+JOINS) or control (celecoxib+placebo) groups. In Part 1, the intervention group will be administered celecoxib once a day and JOINS three times a day for a total of 12 weeks. In the control group, celecoxib will be administered once a day and JOINS placebo three times a day for a total of 12 weeks. In Part 2, JOINS alone and JOINS placebo alone will be administered for an additional 24 weeks in both groups, respectively. The primary endpoint will be the amount of change during the 12 weeks as assessed using the Western Ontario and McMaster Universities Osteoarthritis Index total score compared with baseline. The secondary endpoint will be the amount of change at 1, 4, 12, 24, and 36 weeks from the baseline for pain visual analog scale, Brief Pain Inventory, Short Form Health Survey-36 and biomarkers. Results: The trial was registered with Clinical-Trials.gov (NCT04718649). The clinical trial was also registered on Clinical Research Information Service (CRIS) with the trial registration number KCT0005742. Conclusions: The combination treatment of the most commonly used SYSADOA drug, JOINS, and selective COX-2 inhibitor celecoxib as the representative NSAID for knee OA treatment, can be compared with celecoxib alone treatment to determine the safety or therapeutic effect.

scholarly journals Effects of Cinnamon on Anthropometry Status and Headache Disability of Migraine Patients: A Randomized Double-blind Placebo-controlled Trial

2020 ◽  
Author(s):  
Azadeh Zareie ◽  
Mohammad Bagherniya ◽  
Manoj Sharma ◽  
Fariborz Khorvash ◽  
Akbar Hasanzadeh ◽  
...  
Keyword(s):  
Placebo Group ◽  
Corn Starch ◽  
Controlled Trial ◽  
Intervention Group ◽  
Primary Headache ◽  
Control Group ◽  
Double Blind ◽  
Beneficial Effects ◽  
The Difference ◽  
Headache Disability

Abstract Background: Migraine is a common type of primary headache that is highly disabling and is possibly associated with obesity. Increasing body mass index (BMI) seems to be a risk factor for migraine attacks. Cinnamon has anti-inflammatory, neuroprotective, and anti-obesity effects. Thus, this study aimed to assess the effects of cinnamon on anthropometry status and headache disability of migraine patients.Methods: Fifty patients with migraine were randomized to receive either cinnamon powder, three capsules/day each containing 600 mg of cinnamon or three placebo capsules/day each containing 100 mg of corn starch (control group) for two months. Height, body weight (BW), waist circumference (WC), and hip circumference (HC) were measured at baseline and the end of the study. Furthermore, Minimal or Infrequent Disability (MIDAS) and Headache Daily Result (HDR) Questionnaire were recorded. Results: After follow-up, BW and BMI did not change in the intervention group, however, both of them significantly increased in the placebo group. The differences between the two groups were statistically significant (p=0.001). WC significantly decreased in the cinnamon group and remarkably increased in the control group; the difference between groups was significant (p<0.001). Furthermore, HC and WHR significantly decreased in the intervention group than the placebo group (p=0.001). HDR and the total score of disability in migraine patients were significantly decreased in the intervention versus the control group (p<0.001). Conclusion: Cinnamon seems to have beneficial effects on BW, BMI, WC, and HC and it reduces the headache disability of migraine patients. More randomized controlled trials should be undertaken to confirm these effects.

scholarly journals Mobile Health to Improve Adherence and Patient Experience in Heart Transplantation Recipients: The mHeart Trial

Healthcare ◽  
2021 ◽  
Vol 9 (4) ◽  
pp. 463
Author(s):  
Mar Gomis-Pastor ◽  
Sonia Mirabet Perez ◽  
Eulalia Roig Minguell ◽  
Vicenç Brossa Loidi ◽  
Laura Lopez Lopez ◽  
...  
Keyword(s):  
Heart Transplantation ◽  
Patient Experience ◽  
Mobile Application ◽  
Standard Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Group Versus ◽  
Control Group ◽  
P Value ◽  
Adherence Score

Non-adherence after heart transplantation (HTx) is a significant problem. The main objective of this study was to evaluate if a mHealth strategy is more effective than standard care in improving adherence and patients’ experience in heart transplant recipients. Methods: This was a single-center, randomized controlled trial (RCT) in adult recipients >1.5 years post-HTx. Participants were randomized to standard care (control group) or to the mHeart Strategy (intervention group). For patients randomized to the mHeart strategy, multifaceted theory-based interventions were provided during the study period to optimize therapy management using the mHeart mobile application. Patient experience regarding their medication regimens were evaluated in a face-to-face interview. Medication adherence was assessed by performing self-reported questionnaires. A composite adherence score that included the SMAQ questionnaire, the coefficient of variation of drug levels and missing visits was also reported. Results: A total of 134 HTx recipients were randomized (intervention N = 71; control N = 63). Mean follow-up was 1.6 (SD 0.6) years. Improvement in adherence from baseline was significantly higher in the intervention group versus the control group according to the SMAQ questionnaire (85% vs. 46%, OR = 6.7 (2.9; 15.8), p-value < 0.001) and the composite score (51% vs. 23%, OR = 0.3 (0.1; 0.6), p-value = 0.001). Patients’ experiences with their drug therapy including knowledge of their medication timing intakes (p-value = 0.019) and the drug indications or uses that they remembered (p-value = 0.003) significantly improved in the intervention versus the control group. Conclusions: In our study, the mHealth-based strategy significantly improved adherence and patient beliefs regarding their medication regimens among the HTx population. The mHeart mobile application was used as a feasible tool for providing long-term, tailor-made interventions to HTx recipients to improve the goals assessed.

scholarly journals Azithromycin and hydroxychloroquine in hospitalised patients with confirmed COVID-19–a randomised double-blinded placebo-controlled trial

2021 ◽  
pp. 2100752
Author(s):  
Pradeesh Sivapalan ◽  
Charlotte Suppli Ulrik ◽  
Therese Sophie Lapperre ◽  
Rasmus Dahlin Bojesen ◽  
Josefin Eklöf ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Double Blind ◽  
Safety Outcome ◽  
Hospitalised Patients ◽  
Double Blinded ◽  
Combined Intervention

BackgroundCombining the antibiotic azithromycin and hydroxychloroquine induces airway immunomodulatory effects, with the latter also having in vitro antiviral properties. This may improve outcomes in patients hospitalised for COVID-19.MethodsPlacebo-controlled double-blind randomised multicentre trial. Patients ≥18 years, admitted to hospital for≤48 h (not intensive care) with a positive SARS-CoV-2 RT-PCR test, were recruited. The intervention was 500 mg daily azithromycin for 3 days followed by 250 mg daily azithromycin for 12 days combined with 200 mg twice daily hydroxychloroquine for all 15 days. The control group received placebo/placebo. The primary outcome was days alive and discharged from hospital within 14 days (DAOH14).ResultsAfter randomisation of 117 patients, at the first planned interim analysis, the data and safety monitoring board recommended stopping enrolment due to futility, based on pre-specified criteria. Consequently, the trial was terminated on February 1, 2021. A total of 61 patients received the combined intervention and 56 patients received placebo. In the intervention group, patients had a median of 9.0 DAOH14 (IQR, 3–11) versus. 9.0 DAOH14 (IQR, 7–10) in the placebo group (p=0.90). The primary safety outcome, death from all causes on day 30, occurred for 1 patient in the intervention group versus. 2 patients receiving placebo (p=0.52), and readmittance or death within 30 days occurred for 9 patients in the intervention group versus. 6 patients receiving placebo (p=0.57).ConclusionsThe combination of azithromycin and hydroxychloroquine did not improve survival or length of hospitalisation in patients with COVID-19.

scholarly journals Effect of a breastfeeding educational intervention: a randomized controlled trial

2020 ◽  
Vol 28 ◽  
Author(s):  
Erdnaxela Fernandes do Carmo Souza ◽  
Alfredo Almeida Pina-Oliveira ◽  
Antonieta Keiko Kakuda Shimo
Keyword(s):  
Randomized Controlled Trial ◽  
Educational Intervention ◽  
Exclusive Breastfeeding ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
P Value ◽  
Postpartum Women ◽  
Significance Level ◽  
Randomized Controlled

Objective: to assess the effect of a breastfeeding educational intervention on the counseling provided to postpartum women. Method: this is a randomized controlled trial including 104 postpartum women (intervention group = 52 and control group = 52) from a private hospital, whose educational intervention was based on the pragmatic theory and on the use of a soft-hard technology called Breastfeeding Educational Kit (Kit Educativo para Aleitamento Materno, KEAM). Women were followed-up for up to 60 days after childbirth. Chi-Squared Test, Fischer’s Exact Test, and Generalized Estimating Equation were used, with a significance level of 5% (p-value <0.05). The analyses were performed using the Statistical Package for the Social Sciences, version 24. Results: the postpartum women in the intervention group had fewer breastfeeding difficulties and a higher percentage of exclusive breastfeeding at all time points compared with those in the control group. Conclusion: the educational intervention based on active methodologies and stimulating instructional resources was effective in developing greater practical mastery among postpartum women with regard to adherence and maintenance of exclusive breastfeeding. Registry REBEC RBR – 8p9v7v.

scholarly journals Effect of Oral Ingestion of Low-Molecular Collagen Peptides Derived from Skate (Raja Kenojei) Skin on Body Fat in Overweight Adults: A Randomized, Double-Blind, Placebo-Controlled Trial

Marine Drugs ◽  
2019 ◽  
Vol 17 (3) ◽  
pp. 157 ◽  
Author(s):  
Young Tak ◽  
Yun Kim ◽  
Jeong Lee ◽  
Yu-Hyun Yi ◽  
Young Cho ◽  
...  
Keyword(s):  
Body Fat ◽  
Animal Studies ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Double Blind ◽  
Collagen Peptides ◽  
Collagen Peptide ◽  
Skin Collagen ◽  
Overweight Adults

Recent animal studies found the potential of a collagen peptide derived from skate skin to have anti-obesity effects through the suppression of fat accumulation and regulation of lipid metabolism. However, no studies have yet been performed in humans. Here, this very first human randomized, placebo-controlled, and double-blinded study was designed to investigate the efficacy and tolerability of skate skin collagen peptides (SCP) for the reduction of body fat in overweight adults. Ninety healthy volunteers (17 men) aged 41.2 ± 10.4 years with a mean body mass index of 25.6 ± 1.9 kg/m2 were assigned to the intervention group (IG), which received 2000 mg of SCP per day or to the control group (CG) given the placebo for 12 weeks and 81 (90%) participants completed the study. Changes in body fat were evaluated using dual energy X-ray absorptiometry as a primary efficacy endpoint. After 12 weeks of the trial, the percentage of body fat and body fat mass (kg) in IG were found to be significantly better than those of subjects in CG (−1.2% vs. 2.7%, p = 0.024 and −1.2 kg vs. 0.3 kg, p = 0.025). Application of SCP was well tolerated and no notable adverse effect was reported from both groups. These results suggest the beneficial potential of SCP in the reduction of body fat in overweight adults.

User-driven design of child restraint information to reduce errors in use: a pilot randomised controlled trial

2019 ◽  
Vol 26 (5) ◽  
pp. 432-438 ◽  
Author(s):  
Alexandra B Hall ◽  
Catherine Ho ◽  
Bianca Albanese ◽  
Lisa Keay ◽  
Kate Hunter ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Instructional Materials ◽  
Control Group ◽  
P Value ◽  
Point Increase ◽  
Comprehension Score ◽  
Child Restraint ◽  
Randomised Controlled

BackgroundIncorrect use of child restraints is a long-standing problem that increases the risk of injury in crashes. We used user-centred design to develop prototype child restraint instructional materials. The objective of this study was to evaluate these materials in terms of comprehension and errors in the use of child restraints. The relationship between comprehension and errors in use was also explored.MethodsWe used a parallel-group randomised controlled trial in a laboratory setting. The intervention group (n=22) were provided with prototype materials and the control group (n=22) with existing instructional materials for the same restraint. Participants installed the restraint in a vehicle buck, secured an appropriately sized mannequin in the restraint and underwent a comprehension test. Our primary outcome was overall correct use, and our secondary outcomes were (1) comprehension score and (2) percent errors in the installation trial.ResultsThere was 27% more overall correct use (p=0.042) and a higher mean comprehension score in the intervention group (mean 17, 95% CI 16 to 18) compared with the control group (mean 12, 95% CI 10 to 14, p<0.001). The mean error percentage in the control group was 23% (95% CI 16% to 31%) compared with 14% in the intervention group (95% CI 8% to 20%, p=0.056). For every one point increase in comprehension, there was an almost 2% (95% CI −2.7% to −1.0%) reduction in errors (y=45.5–1.87x, p value for slope <0.001).ConclusionsConsumer-driven design of informational materials can increase the correct use of child restraints. Targeting improved comprehension of informational materials may be an effective mechanism for reducing child restraint misuse.

scholarly journals Effects of Bupropion on Cognitive Function in Schizophrenia: A Double Blind Randomized Controlled Trial

2016 ◽  
Vol 9 (5) ◽  
pp. 67
Author(s):  
Mansoureh Mirzadeh ◽  
Najmeh Shahini ◽  
Masoud Kashani Lotf Abadi ◽  
Maryam Tavakoli ◽  
Arash Javanbakht ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Function ◽  
Rating Scale ◽  
Controlled Trial ◽  
Control Group ◽  
P Value ◽  
Double Blind ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Schizophrenic Patients

<p>Smoking habits are common in schizophrenic patients. Nicotine can suppress negative symptoms and cognitive impairments. The aim of this study was to determine the efficacy of bupropion on cognitive function in schizophrenic patients.<strong> </strong>This study is a double blind randomized controlled trial in a large referral psychiatric university hospital in Iran. Ninety smoker schizophrenic patients were randomly allocated (based on DSM -IV TR criteria) in two groups (46 patients for case group and 44 patients in control group). They get risperidone up to 6 mg/d and bupropion up to 400 mg/d .clinical assessment (Positive and Negative Syndrome Scale (PANSS), Brief psychiatric rating scale (BPRS) were taken in beginning of study, 14<sup>th</sup> and 28<sup>th</sup> days of study. Cognitive assessment (Stroop, Digit Span, and Wechsler, Wisconsin) were taken in begging of study, the days 2<sup>nd</sup>, 7<sup>th</sup>, 14<sup>th</sup>, 28<sup>th</sup>. All data were analyzed by SPSS Ver. 17 with analytic and descriptive tests. Mean age of patients was 37.66±1.01. Mean duration of disorder was 11.63±.98 years. The scores were significantly lower at the day 28<sup>th</sup> compared to the beginning of the study in both groups in Wechsler, Stroop color word , Stroop word , Stroop color , BPRS, PANSS p value ≤0.05 .The difference between the two treatments was not significant as indicated by the effect of group, the between-subjects factor<strong> </strong><strong>p </strong>value ≥0.05. In this study, the side effects were examined and there was no significant difference between the two groups p value ≥0.05.<strong> </strong>Augmentation of bupropion to routine treatment improves cognitive symptoms of schizophrenia in abstinence of tobacco.</p>

scholarly journals Pharmaceutical-grade Chondroitin sulfate is as effective as celecoxib and superior to placebo in symptomatic knee osteoarthritis: the ChONdroitin versus CElecoxib versus Placebo Trial (CONCEPT)

2017 ◽  
Vol 76 (9) ◽  
pp. 1537-1543 ◽  
Author(s):  
Jean-Yves Reginster ◽  
Jean Dudler ◽  
Tomasz Blicharski ◽  
Karel Pavelka
Keyword(s):  
Placebo Group ◽  
Knee Osteoarthritis ◽  
Chondroitin Sulfate ◽  
Controlled Trial ◽  
European Medicines Agency ◽  
Double Blind ◽  
Knee Oa ◽  
Symptomatic Knee Osteoarthritis ◽  
Symptomatic Knee ◽  
Secondary Endpoints

ObjectivesChondroitin sulfate 800 mg/day (CS) pharmaceutical-grade in the management of symptomatic knee osteoarthritis consistent with the European Medicines Agency guideline.MethodsA prospective, randomised, 6-month, 3-arm, double-blind, double-dummy, placebo and celecoxib (200 mg/day)-controlled trial assessing changes in pain on a Visual Analogue Scale (VAS) and in the Lequesne Index (LI) as coprimary endpoints. Minimal-Clinically Important Improvement (MCII), Patient-Acceptable Symptoms State (PASS) were used as secondary endpoints.Results604 patients (knee osteoarthritis) diagnosed according to American College of Rheumalogy (ACR) criteria, recruited in five European countries and followed for 182 days. CS and celecoxib showed a greater significant reduction in pain and LI than placebo. In the intention-to-treat (ITT) population, pain reduction in VAS at day 182 in the CS group (−42.6 mm) and in celecoxib group (−39.5 mm) was significantly greater than the placebo group (−33.3 mm) (p=0.001 for CS and p=0.009 for celecoxib), while no difference observed between CS and celecoxib. Similar trend for the LI, as reduction in this metric in the CS group (−4.7) and celecoxib group (−4.6) was significantly greater than the placebo group (−3.7) (p=0.023 for CS and p=0.015 for celecoxib), no difference was observed between CS and celecoxib. Both secondary endpoints (MCII and PASS) at day 182 improved significantly in the CS and celecoxib groups. All treatments demonstrated excellent safety profiles.ConclusionA 800 mg/day pharmaceutical-grade CS is superior to placebo and similar to celecoxib in reducing pain and improving function over 6 months in symptomatic knee osteoarthritis (OA) patients. This formulation of CS should be considered a first-line treatment in the medical management of knee OA.

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