scholarly journals Study on efficacy and safety of Tong-luo Qu-tong plaster treatment for knee osteoarthritis: study protocol for a randomised, double-blind, parallel positive control, multi-center clinical trial

2019 ◽  
Author(s):  
Bao-ping Xu ◽  
Min Yao ◽  
Zi-rui Tian ◽  
Long-yun Zhou ◽  
Long Yang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Knee Osteoarthritis ◽  
Clinical Symptoms ◽  
Positive Control ◽  
Control Group ◽  
Efficacy And Safety ◽  
Adhesive Plaster ◽  
Double Blind ◽  
Experimental Group

Abstract Background: Knee osteoarthritis (KOA) is a common chronic musculoskeletal disorder that seriously affect quality of life. Patients with KOA frequently develop one or more of the typically following symptoms: joint pain, stiffness, joint friction noise, impaired functionality. Traditional Chinese medicines (TCM) have showed a superior effect and peculiar advantage on the treatment of KOA, among TCMs, the Tong-luo Qu-tong plaster is the convenient and most commonly used method in China to improve symptoms including pain, stiffness and limited mobility in patients with KOA, as it causes few adverse effects. But there is a lack of high quality of clinical evidences to support the therapeutic effect that Chinese adhesive plaster can relieve pain and stiffness. The purpose of this study will be to evaluate the efficacy and safety of Tong-luo Qu-tong plaster in patients with KOA. Methods/Design: This study will be a randomised, double-blind, parallel positive control, multi-center clinical trial, a non-inferiority trial design was adopted. A total of 2000 participants older than 40 years with KOA, will be randomly allocated into a experimental group (n=1500) and a control group (n=500). All participants will receive a conventional conservative treatment lasted for 14 days as two courses, daily 1 time. Tong-luo Qu-tong plaster will be administered externally to participants in the experimental group, while the control group will receive a Qi-zheng Xiao-tong plaster. The outcome of the total Western Ontario and McMaster Universities Arthritis Index scores, TCM syndrome quantitative score, visual analog scale scores will be measured during the assessment visits (baseline and 1-, 2-week follow-up). In addition, adverse events concerning clinical symptoms and signs as well as laboratory tests will be documented during clinical trials. Discussion: This study will be a randomized, double-blind, parallel positive control trial to further evaluate the effectiveness and safety of Tong-luo Qu-tong plaster for patients with KOA in nine medical centers compared with control group, it is expected that the patients with KOA will benefit from this study.

scholarly journals Study on efficacy and safety of Tong-luo Qu-yu plaster treatment for knee osteoarthritis: study protocol for a randomised, double-blind, parallel positive control, multi-center clinical trial

2019 ◽  
Author(s):  
Bao-ping Xu ◽  
Min Yao ◽  
Zi-rui Tian ◽  
Long-yun Zhou ◽  
Long Yang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Knee Osteoarthritis ◽  
Clinical Symptoms ◽  
Positive Control ◽  
Control Group ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Experimental Group

Abstract Background: Knee osteoarthritis (KOA) is a common chronic musculoskeletal disorder that seriously affect quality of life. Patients with KOA frequently develop one or more of the typically following symptoms: joint pain, stiffness, joint friction noise, impaired functionality. Traditional Chinese medicines (TCM) have showed a superior effect and peculiar advantage on the treatment of KOA, among TCMs, the Tong-luo Qu-yu plaster is the convenient and most commonly used method in China to improve symptoms including pain, stiffness and limited mobility in patients with KOA, as it causes few adverse effects. But there is a lack of high quality of clinical evidences to support the therapeutic effect that Chinese adhesive plaster can relieve pain and stiffness. The purpose of this study will be to evaluate the efficacy and safety of Tong-luo Qu-yu plaster in patients with KOA. Methods: This study will be a randomised, double-blind, parallel positive control, multi-center clinical trial. A total of 2000 participants older than 40 years with KOA, will be randomly allocated into a experimental group (n=1500) and a control group (n=500). All participants will receive a conventional conservative treatment lasted for 14 days as two courses, daily 1 time. Tong-luo Qu-yu plaster will be administered externally to participants in the experimental group, while the control group will receive a Qi-zheng Xiao-tong plaster. The outcome of the total Western Ontario and McMaster Universities Arthritis Index scores, TCM syndrome quantitative score, visual analog scale scores will be measured during the assessment visits (baseline and 1-, 2-week follow-up). In addition, adverse events concerning clinical symptoms and signs as well as laboratory tests will be documented during clinical trials. Discussion: This study will be a randomized, double-blind, parallel positive control trial to further evaluate the effectiveness and safety of Tong-luo Qu-yu plaster for patients with KOA in nine medical centers compared with control group, it is expected that the patients with KOA will benefit from this study. Trial Registration: ClinicalTrials.gov, NCT03309501. Registered on 08 November 2017. Keywords: Clinical trials, Knee osteoarthritis, Tong-luo Qu-yu plaster, Randomized, Protocol

scholarly journals A Preliminary Study on the Safety, Efficacy and Acceptability of the Community Preparation of Siling Labuyo (Capsicum frutescens) Liniment in the Management of Knee Osteoarthritis in a Six-Week, Active-Controlled Community-Based Clinical Trial

2019 ◽  
Vol 53 (4) ◽  
Author(s):  
Elizabeth R. Paterno ◽  
Clarisse A. Pangilinan ◽  
Erna C. Arollado ◽  
Rachael Marie B. Rosario
Keyword(s):  
Clinical Trial ◽  
Knee Osteoarthritis ◽  
Control Agent ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Control Groups ◽  
Double Blind ◽  
The Difference ◽  
And Control ◽  
Experimental Group

Objective. The study determined the safety, efficacy and acceptability of a Philippine community preparation of Siling Labuyo liniment in the management of knee osteoarthritis. Methods. A 6-week randomized, double-blind, active-controlled clinical trial was conducted in three municipalities of Cavite from 2017-2018. The municipalities were randomly assigned to either the control or experimental group, using a commercially available Diclofenac 1% gel as the control agent. Knee Injury and Osteoarthritis Outcome Score (KOOS) and Pain Visual Analogue Scale (VAS) were used to measure the outcomes. Results. Forty-seven participants completed the study. Statistically significant improvement (p<0.05) in pain relief, reduction of symptoms and increase in knee functionality was reported by participants in both the experimental and control groups. Across the dimensions measured, at least 30% improvement in scores was reported by the experimental group, and at least 40% by the control group. The difference was statistically not significant (p>0.05). Itching (13%), burning sensation (11%) and reddening of the skin (15%) were experienced in both the experimental and the active control groups. Conclusion. Use of the liniment led to a modest therapeutic effect and was well-tolerated by the participants.

scholarly journals Effects of a positive thinking program on hope and sleep quality in Iranian patients with thalassemia: a randomized clinical trial

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Somayeh Makaremnia ◽  
Marieh Dehghan Manshadi ◽  
Zahra Khademian
Keyword(s):  
Clinical Trial ◽  
Sleep Quality ◽  
Training Program ◽  
Randomized Clinical Trial ◽  
Thalassemia Major ◽  
Trial Registration ◽  
Control Group ◽  
Positive Thinking ◽  
Experimental Group

Abstract Background Thalassemia have a negative impact on the patients' psychological health and sleep quality. This study aimed to determine the effects of a positive thinking training program on hope and sleep quality of patients with thalassemia major. Methods This randomized clinical trial was conducted on 78 patients with thalassemia major including 36 males (46.2%) and 42 females (53.8%) with a mean age of 25.56 ± 29.6 in Iran. Subjects were randomly assigned into experimental and control groups. Experimental group received 16 h training based on positive thinking materials published by Martin Seligman. Control group received only usual programs. Data were collected at baseline, as well as immediately and one month after the intervention, using Snyder’s Hope Scale and the Pittsburgh Sleep Quality Index. Data analysis was performed using SPSS Software 18.0; statistical tests included the independent T-test, the Chi-square, Mann Whitney, and Friedman test. Significance level was set at 0.05 in this study. Results The experimental group had a significantly higher mean hope score compared to the control group immediately (45.38 ± 7.82 vs. 35.32 ± 5.54, P < 0.001) and one month following intervention (44.67 ± 3.47 vs. 35 ± .54, P < 0.001). Moreover, the mean sleep quality scores of the experimental group was significantly greater than that for control group immediately (5.35 ± 2.02 vs. 7 ± 2.4, P = 0.004) and one month after the intervention (4.23 ± 2.2 vs.7.02 ± 3.03, P < 0.001). Conclusion Since our training program on positive thinking improved hope and quality of sleep in patients with thalassemia major, we recommend the use of such courses as an important step toward promotion of hope and sleep quality among these patients. Trial registration The name of the registry: Iranian Registry of Clinical Trials. Trial Registration Number: IRCT2017010431774N1. URL of the trial registry record: https://en.irct.ir/trial/24923. Registration Date: 07/03/2017.

scholarly journals Efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia: a protocol for randomised double-blind controlled clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e041958
Author(s):  
Nirmani Yasara ◽  
Nethmi Wickramarathne ◽  
Chamila Mettananda ◽  
Aresha Manamperi ◽  
Anuja Premawardhena ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sri Lanka ◽  
Intervention Group ◽  
Primary Outcome Measure ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Scientific Publications ◽  
Double Blind ◽  
Fetal Haemoglobin

IntroductionDespite being one of the first diseases to be genetically characterised, β-thalassaemia remains a disorder without a cure in a majority of patients. Most patients with β-thalassaemia receive only supportive treatment and therefore have a poor quality of life and shorter life spans. Hydroxyurea, which has shown to induce fetal haemoglobin synthesis in human erythroid cells, is currently recommended for the treatment of sickle cell disease. However, its clinical usefulness in transfusion-dependent β-thalassaemia is unclear. Here, we present a protocol for a randomised double-blind controlled clinical trial to evaluate the efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia.Methods and analysisThis single-centre randomised double-blind placebo-controlled clinical trial is conducted at the Thalassaemia Centre of Colombo North Teaching Hospital, Ragama, Sri Lanka. Adult and adolescent patients with haematologically and genetically confirmed transfusion-dependent β-thalassaemia are enrolled and randomised into the intervention or control group. The intervention group receives oral hydroxyurea 10–20 mg/kg daily for 6 months, while the control group receives a placebo which is identical in size, shape and colour to hydroxyurea without its active ingredient. Transfused blood volume, pretransfusion haemoglobin level, fetal haemoglobin percentage and adverse effects of treatment are monitored during treatment and 6 months post-treatment. Cessation or reduction of blood transfusions during the treatment period will be the primary outcome measure. The statistical analysis will be based on intention to treat.Ethics and disseminationEthical approval has been obtained from the Ethics Committee of Faculty of Medicine, University of Kelaniya (P/116/05/2018) and the trial is approved by the National Medicinal Regulatory Authority of Sri Lanka. Results of the trial will be disseminated in scientific publications in reputed journals.Trial registration numberSLCTR/2018/024; Pre-results.

scholarly journals Efficacy and Safety of Socheongryong-Tang Among Atopic Dermatitis Patients With Respiratory Disorders: A Double-Blinded, Randomized, Placebo-Controlled Clinical Trial

2020 ◽  
Vol 11 ◽  
Author(s):  
Ju Hyun Lee ◽  
Eun Heui Jo ◽  
Jee Youn Jung ◽  
Young-Eun Kim ◽  
Mi-Ju Son ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Atopic Dermatitis ◽  
Safety Evaluation ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Inflammatory Skin Disease ◽  
Double Blinded ◽  
Study Participants ◽  
Experimental Group

Atopic dermatitis is a chronic inflammatory skin disease that affects the growth and development of children. The prevalence of atopic dermatitis has been continually increasing, and this has also been accompanied by rising socioeconomic costs. Interest has been growing in alternative medicine as a means of alleviating the burden of atopic dermatitis. This was a single-center, double-blinded, randomized, placebo-controlled investigator-led clinical trial including 60 atopic dermatitis patients. The participants were classified into an experimental group (30 persons) and a control group (30 persons), who were administered, respectively, socheongryong-tang or a placebo for 4 weeks. After 4 weeks of treatment, the participants visited the trial center again and assess their efficacy and safety. The researchers performed statistical comparisons of the changes in the SCORAD Index, amount and frequency of ointment use, and height and weight to assess the efficacy. To assess the safety, diagnostic tests and vital sign checks were performed at each visit, and the presence or absence of adverse events was observed. As a result, the frequency and the amount of steroid ointment application in both groups increased, but the experimental group showed less tendency (p = 0.081). Results of analyzing the children in the experimental group in relation to growth showed a significantly greater height growth than the control group (p &lt; 0.05). In addition, all study participants did not show any remarkable abnormal signs in the safety evaluation. In conclusion, compared to the control group, the experimental group, who took socheongryong-tang showed a tendency to be less dependent on steroid ointment and statistically significant increase in height.

scholarly journals Effectiveness of a Program Combining Strengthening, Stretching, and Aerobic Training Exercises in a Standing versus a Sitting Position in Overweight Subjects with Knee Osteoarthritis: A Randomized Controlled Trial

2020 ◽  
Vol 9 (12) ◽  
pp. 4113
Author(s):  
Betsy Denisse Perez-Huerta ◽  
Belén Díaz-Pulido ◽  
Daniel Pecos-Martin ◽  
David Beckwee ◽  
Enrique Lluch-Girbes ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Knee Osteoarthritis ◽  
Knee Pain ◽  
Controlled Trial ◽  
Exercise Program ◽  
Control Group ◽  
Global Increase ◽  
Experimental Group ◽  
Overweight Subjects

There is an increasing incidence, prevalence, and burden of knee osteoarthritis due to a global increase in obesity and an aging population. The aim of the present study was to compare the effectiveness of the addition of aerobic exercises performed in an unloaded or loaded position to a conventional exercise program in overweight subjects with knee osteoarthritis. Twenty-four subjects were randomly allocated to receive 36 sessions of 30-min duration of either sitting aerobic exercises (experimental group) or standing aerobic exercises (control group). Pain intensity, knee disability, and quality-of-life data were collected at baseline and at 12, 24, and 36 sessions. Generalized linear mixed models (GLMMs) were constructed for the analysis of the differences. Significant differences were found in the experimental group for self-reported pain and knee pain and disability at 24 and 36 sessions (p < 0.05). Significant between-group differences were observed in change in self-reported knee pain and disability and quality of life from baseline to 24th- and 36th-session measurements in favor of the experimental group. Adherence to treatment was higher in the experimental group. Adding aerobic exercises in an unloaded position to a conventional exercise program produced superior effects over time for self-reported knee pain, knee pain and disability and quality of life compared to loaded aerobic exercises in overweight subjects with knee osteoarthritis.

scholarly journals Anerning Granule for Community Acquired Pneumonia: Protocol for Randomized, Double-Blind, Single-Dummy, Parallel Control of Placebo, Multicenter Clinical Trial

2021 ◽  
Author(s):  
Menghua Sun ◽  
Jian Lyu ◽  
Yi-li Zhang ◽  
Xu Wei ◽  
Li-dan Zhang ◽  
...  
Keyword(s):  
Adverse Events ◽  
Community Acquired Pneumonia ◽  
Clinical Treatment ◽  
Secondary Outcome ◽  
Control Group ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Ceftriaxone Sodium ◽  
Parallel Control ◽  
Experimental Group

Abstract Background: Community acquired pneumonia (CAP) in children is one of the common clinical diseases and infectious diseases threatening the health of the population. CAP has complicated causes, closely related to region, season, age, and primary disease. It is the most common cause of children being hospitalized and the first cause of death for children under 5 years old. At present, the clinical treatment is mainly antibiotics, but abuse and non-standard combination of antibiotics have led to increasing antibiotic resistance. Anerning Granules have the functions of clearing away heat and removing wind, reducing phlegm and relieving cough, and improving cough symptoms and lung signs. Thus, this study aims to evaluate the efficacy and safety of Anerning Granules (AEN) in the treatment of community-acquired pneumonia in children, and to explore whether AEN can reduce the use of antibiotics and have a good effect on the clinical treatment of CAP.Methods and analysis: this study, a randomized, double-blind, single-dummy, parallel control of placebo, multicenter clinical study will be established in 7 hospitals in the same period. A total of 216 patients with community-acquired pneumonia will be randomly allocated at a ratio of 2:1 to two groups: experimental group, control group. The experimental group receives Anerning Granules plus ceftriaxone sodium; the control group receives AEN placebo plus ceftriaxone sodium. Each group will be treated for ten days, and a stage effect evaluation will be conducted on the sixth day. The primary outcome is the end of antibiotics in frequency (DDDs) and effective rate. Secondary outcome measures of effectiveness are the full fever time, sore throat onset time, and safety assessment. Outcomes will be assessed at baseline and after treatment. In addition, adverse events will be monitored throughout the trial process and must be traced to be resolved.Discussion: This study protocol will provide the research data regarding the efficacy and safety of AEN for the treatment of community-acquired pneumonia in children. The first aim is to determine whether Anerning Granules can reduce the use of antibiotics; the second aim is to evaluate the effectiveness of Anerning Granules combined with ceftriaxone sodium in the treatment of children with community-acquired pneumonia. The third aim is to observe the safety of clinical application of Anerning Granules. The results of this study will improve the rational use of drugs, especially the rational application of antibiotics. It will also enable safety evaluation from laboratory indices of adverse events, which will provide reliable evidence for clinical treatment.Trial registration: Clinicaltrials.gov identifier: NCT03675178, registered on 16 September 2018.

scholarly journals Effectiveness of ginger in reducing metabolic levels in people with diabetes: a randomized clinical trial

2020 ◽  
Vol 28 ◽  
Author(s):  
Gerdane Celene Nunes Carvalho ◽  
José Claudio Garcia Lira-Neto ◽  
Márcio Flávio Moura de Araújo ◽  
Roberto Wagner Júnior Freire de Freitas ◽  
Maria Lúcia Zanetti ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Clinical Trial ◽  
Blood Sugar ◽  
Zingiber Officinale ◽  
Secondary Outcome ◽  
Control Group ◽  
Double Blind ◽  
Experimental Group ◽  
Hba1c Levels

Objective: to evaluate the effectiveness of ginge (Zingiber officinale) in reducing blood sugar and lipid levels in people with type 2 diabetes. Method: a randomized and double-blind clinical trial conducted with people with type 2 diabetes in primary care facilities. The study included individuals aged between 20 and 80 years old, using oral antidiabetic drugs and with HbA1c levels between 6.0% and 10%. The participants were paired 1:1, allocated in two distinct groups, and randomized in blocks, based on their HbA1c levels. In the experimental group, the participants used 1.2g of ginger and, in the control group, 1.2g of placebo, daily for 90 days. The primary outcome was a reduction in fasting blood sugar and HbA1c, and the secondary outcome was a reduction in lipids and HOMA-IR. 103 individuals completed the study, 47 in the experimental group and 56 in the control group. Results: the participants in the experimental group showed a greater reduction in the blood glucose and total cholesterol values compared to the control group. Conclusion: the use of ginger can help in the treatment of people with diabetes, and data support the inclusion of this herbal drug in the clinical practice of nurses. RBR-2rt2wy

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