scholarly journals A Double-Blind, Randomized Controlled 12-Week Follow-Up Trial to Evaluate the Efficacy and Safety of Polycan in Combination with Glucosamine for the Treatment of Knee Osteoarthritis

2019 ◽  
Vol 2019 ◽  
pp. 1-8 ◽  
Author(s):  
Thi Thanh Thuy Truong ◽  
Jong Min Lim ◽  
Hyung-Rae Cho ◽  
Young Suk Kim ◽  
Duc Giang Dao ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Rescue Medication ◽  
Secondary Outcome ◽  
Control Group ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Randomized Controlled ◽  
Patient Reported ◽  
Group A ◽  
Group B

Aim. The aim of the present study was to examine the efficacy and safety of Polycan, a β-glucan produced from the black yeast Aureobasidium pullulans SM-2001, in combination with glucosamine in reducing knee osteoarthritis-associated symptoms. Methods. This was a double-blind, randomized controlled trial of a formulated product composed of 16.7 mg of Polycan and 250 mg of glucosamine (Group A), 16.7 mg of Polycan and 500 mg of glucosamine (Group B), or 500 mg of glucosamine (control group) per capsule, administered as three capsules once per day over a period of 12 weeks, conducted with 100 osteoarthritis patients, aged 35–80 years. The primary outcome measure was osteoarthritis symptoms assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire. The secondary outcome measures included rescue medication use (according to data from a patient-reported diary) and other safety indices (body weight, blood pressure, hematological, and biochemistry markers). Results. Compared with the control group, Group B demonstrated a statistically significant reduction in the total WOMAC score after 12 weeks of treatment (p < 0.05). There was a significant reduction in the frequency of rescue medication used in Groups A and B compared with the control group (p < 0.05). There were no significant changes in hematology and biochemistry parameters or health indices between the active and the control group. Conclusion. Among patients with mild or moderate osteoarthritis, a daily oral dose of Polycan (50 mg) in combination with glucosamine (750 mg or 1500 mg; Group A or B, respectively) resulted in a better treatment outcome than treatment with glucosamine (1500 mg) alone.

scholarly journals Prevention of Hypertension at Intubation: A Controlled Study of Sublingual Nifedipine

2020 ◽  
Vol 2 (1) ◽  
pp. 37-40
Author(s):  
Nirmal Kumar Gyawali
Keyword(s):  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Inhalation Anesthesia ◽  
Randomized Controlled ◽  
Sublingual Nifedipine ◽  
Group A ◽  
Prevention Of Hypertension ◽  
Group B ◽  
Adrenergic Blocking

Background: Hypertension and tachycardia-induced after laryngoscopy and intubation can be prevented by various methods like deep inhalation anesthesia, intravenous opioids, topical intravenous lidocaine, intravenous adrenergic blocking drugs, and pretreatment with antihypertensive.Methods: It is a randomized controlled double-blind prospective study of two groups consisting of 30 patients in each group. Group A was the control group and group B were Nifedipine group who were pretreated with Nifedipine. This study aimed to assess the effectiveness of pretreatment with nifedipine in the prevention of the hypertensive response to laryngoscopy and endotracheal intubation in normotensive patients undergoing elective surgery.Result: Sublingual nifedipine was significantly effective in decreasing systolic and diastolic blood pressure produced by laryngoscopy and tracheal intubation, but its role in decreasing pulse rate was not significant. Conclusion: Nifedipine is useful to prevent laryngoscopy and intubation induced hemodynamic response.

scholarly journals Treatment of knee osteoarthritis with traditional Chinese medicine sloughingClinical efficacy study

2020 ◽  
Vol 8 (2) ◽  
Author(s):  
Liang Wen
Keyword(s):  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Knee Osteoarthritis ◽  
Western Medicine ◽  
Clinical Effect ◽  
Effective Rate ◽  
Control Group ◽  
Observation Group ◽  
Group A ◽  
Group B

Objective: To explore the clinical effect of the treatment of knee osteoarthritis with traditional Chinese medicine.Methods: 152 patients with knee osteoarthritis who were treated in our hospital from July 2018 to April 2020 were divided into two groups. Group A (control group) was treated with conventional western medicine, i.e. celecoxib 200 mg capsule +Glucosamine hydrochloride capsule 0.75g, group B (observation group): the treatment of traditional Chinese medicine sloughing using our experience formula, and further comparative evaluation of the treatment effect of the two groups. Results: the effective rate was 75% in the control group and 92% in the observation group. Conclusion: in the treatment of knee osteoarthritis, traditional Chinese medicine is more effective than western medicine.

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 The Efficacy and Safety of Acupuncture for Prophylaxis of Vestibular Migraine: A Study Protocol for a Randomized Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Tianye Hu ◽  
Hantong Hu ◽  
Feng Chen ◽  
Bin Jiang ◽  
Fengfei Shen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Outcome Measures ◽  
Vestibular Migraine ◽  
Secondary Outcome ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Randomized Controlled

Introduction: With a high incidence rate and low diagnosis rate, vestibular migraine (VM) can seriously affect the quality of life of patients, but it remains difficult to manage by current treatment options. Acupuncture may be a potential treatment option for VM prophylaxis, but the currently available evidence is still uncertain. Therefore, this trial aims to evaluate the efficacy and safety of acupuncture for VM prophylaxis.Methods: This is a 28-week parallel, randomized, controlled clinical trial including 4 weeks of baseline, 8 weeks of treatment, and 16 weeks of follow-up. A total of 72 participants will be randomly assigned to two groups. The participants will receive acupuncture in the experimental group, while the participants in the control group will be treated with venlafaxine. The primary outcome measures are change in vertigo/migraine days and vertigo/migraine attacks, vertigo severity, and migraine intensity per 4 weeks from baseline. The secondary outcome measures are change in doses of rescue medication, anxiety level, depression level, and quality of life per 4 weeks from baseline. Adverse events will be recorded for safety evaluation.Discussion: This study will investigate the efficacy and safety of acupuncture for VM prophylaxis. The results will contribute to determining whether acupuncture can serve as an optional treatment strategy for treating VM.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT0464088.

scholarly journals Effect of Single Dose of Pregabalin on Post Tracheal Intubation Sore Throat after General Anesthesia

2019 ◽  
Author(s):  
Hassan Mohammadipour Anvari ◽  
Maarouf Ansari Kazaj ◽  
Khosro Kolahdouzan ◽  
Nasser Ghobanian ◽  
Afsaneh Khobeydeh
Keyword(s):  
Single Dose ◽  
Tracheal Intubation ◽  
General Anesthesia ◽  
Sore Throat ◽  
Control Group ◽  
Case Group ◽  
Double Blind ◽  
Analgesic Effects ◽  
Group A ◽  
Group B

Background: Sore throat is one of the major complications of tracheal intubation after general anesthesia. Pregabalin is an analgesic, the anti neuropathic pain and analgesic effects of which have been demonstrated in various studies. This study examined the effects of single dose pregabalin one hour before tracheal intubation, to prevent sore throat after extubation. Methods: In a double-blind, randomized clinical trial, 60 patients who had undergone general and urologic surgeries at Imam Reza hospital in Tabriz, Iran, since March to July 2015 that required tracheal intubation, were included in the study. The patients were randomly divided into two groups (group A, 30 patients and group B, 30 patients). In the group A, an hour before anesthesia, one pregabalin tablet (300mg) was given to the patients. For the patients of the group B, the placebo was given. After awareness of patients, the severity of sore throat was measured and recorded by VAS scale after 2, 6 and 24 hours of the surgery. Results: Severity and incidence of sore throat after tracheal intubation were not significantly different between two groups. Meanwhile, no side effects of pregabalin were observed in the group A. Conclusion: Administration of pregabalin as a single dose of 300 mg one hour prior to anesthesia and intubation decreased the incidence and severity of sore throat in the case group than the control group, although the amount of this reduction was not statistically significant between the two groups.

scholarly journals Randomized Controlled Clinical Trial Comparing Transurethral Eneucleation and Resection of Prostate and Trans-urethral Resection of Prostate in the Management of Benign Prostatic Hyperplasia

2017 ◽  
Vol 7 (3) ◽  
pp. 216-220
Author(s):  
Md Mehedi Hasan ◽  
Samira Rahat Afroze ◽  
Muhammad Abdur Rahim ◽  
Muhammad Abdus Salam
Keyword(s):  
Controlled Trial ◽  
Ethical Review ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Transurethral Resection Of Prostate ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Group A ◽  
The Mean ◽  
Group B

Background: Transurethral resection of prostate (TURP) is the predominant surgical procedure for benign prostatic hypertension (BPH) but is not devoid of complications like capsular perforation, drop in Hb%, drop in Na+, residual adenoma; hence endeavors are evolving to combat such complications. A newer technique transurethral enucleation and resection of prostate (TUERP) has been devised to solve these problems. This study was designed to compare the safety and the efficacy of newer technique, TUERP with widely practiced TURP Methods: This randomized controlled trial was done at BSMMU, after getting ethical approval from the ethical review committee of the institute, from January to October, 2009. A total of 60 BPH patients were purposively enrolled in this study, after obtaining informed written consent and they were randomized as control, Group A (30 patients, underwent TURP) and experimental group, Group B (30 patients, underwent TEURP).Results: The mean preoperative Hb% level of Group A was 15.1 gm% (SD ± 0.5) and perioperative Hb% level was 13.04 gm% (SD ± 6.06). There was significant difference (P <0.05). The mean preoperative Hb% of Group B was 15.2 gm% (SD ± 0.5) and perioperative Hb% was 15.2 gm% (SD ± 0.48). There was no difference (P >0.05). The mean preoperative Na + of Group A was 140 mmol/l (SD ± 4.1) and perioperative Na+ was 126 mmol/l (SD ± 6.8). There was significant difference (P<0.01). The mean preoperative Na+ of Group B was 136 mmol/l (SD ± 4) and perioperative Na+ was 136 mmol/l (SD ± 2.70). There was no difference (P >0.05).Conclusion: TUERP eliminates drop in Hb% and Na+which are usual consequences following TURP. Thus TUERP can be advocated in the treatment of BPH as it also allows completeresection down to surgical capsule.Birdem Med J 2017; 7(3): 216-220

scholarly journals Comparative Study of the Effect of Midazolam Administration Before and after Seizures on the Prevention of Complications in Children Undergoing Electroconvulsive Therapy Compared with a Control Group

2022 ◽  
Author(s):  
Mehrdad Masoudifar ◽  
Behzad Nazemroaya ◽  
Maryam Raisi
Keyword(s):  
Muscle Pain ◽  
Anterograde Amnesia ◽  
Control Group ◽  
Seizure Duration ◽  
Double Blind ◽  
Double Blind Clinical Trial ◽  
Before And After ◽  
Group A ◽  
Effective Role ◽  
Group B

Background: One of the complications of ECT treatment is headache. There is a need to use sedation during ECT. As a result, midazolam has been used to address a safe and effective strategy in this regard. Methods: This study is a double-blind clinical trial that has been performed in three groups: group A, which receives midazolam based on the usual regimen, group B, which receives midazolam after shock, and group C, which is the control group. Patients were asked about headache, nausea, and muscle aches during the recovery time, seizure duration and after becoming fully conscious. Data were analyzed in the PASW version18 software using analysis of variance and repeated measurement tests, ANOVA, independed t and χ2 tests. Results: Analysis showed that the frequency of muscle pain after full consciousness in group C was significantly higher than group B, with group B being higher than group A. χ2 test showed that the frequency of headache, cough and nausea in group C was significantly higher than the two groups A and B. Conclusion: The result of this research showed that midazolam prodrug plays an effective role in preventing post-ECT complications in children. The effect of midazolam before and after ECT on headache, muscle pain and nausea was investigated and compared with the control group. Also, due to its anterograde amnesia, midazolam can reduce the patient's stress in the next visits, and this issue is even more important when the patient is a child.

scholarly journals Clinical Assessment of Rosemary-based Toothpaste (Rosmarinus officinalis Linn.): A Randomized Controlled Double-blind Study

2019 ◽  
Vol 30 (2) ◽  
pp. 146-151
Author(s):  
Marcela A. A. Valones ◽  
Ingrid Carla Guedes Silva ◽  
Luiz Alcino Monteiro Gueiros ◽  
Jair Carneiro Leão ◽  
Arnaldo F. Caldas Jr ◽  
...  
Keyword(s):  
Relative Risk ◽  
Risk Reduction ◽  
Rosmarinus Officinalis ◽  
Double Blind Study ◽  
Double Blind ◽  
Randomized Controlled ◽  
Gingival Bleeding ◽  
Group A ◽  
Group B ◽  
Bacterial Plaque

Abstract The present study was to investigate the action of a toothpaste made from the extract of Rosmarinus officinalis Linn. (rosemary) in a clinical randomized, controlled, open and double-blind trial. One hundred and ten volunteers fulfilled the inclusion criteria and were randomly separated into two groups according to the toothpastes used: Group A (experimental) and Group B (control). They were assessed at baseline and 30 days after the study using the gingival bleeding index (GBI) and the plaque index (PI). Data analysis was conducted to calculate the effects of the two toothpastes on gingival bleeding and plaque, using measurements such as the excess relative risk (ERR), the Relative Risk Reduction (RRR), the Absolute Risk Reduction (ARR) and the Number Needed for Treatment (NNT). The two toothpastes provided similar results in terms of the reduction in the risk of gingival bleeding (relative and absolute): a reduction of 38% in Group A, ERR=0.38; a reduction of 29.3% in Group B, ERR=0.293; A and B reduced by 18% ARR=0.18). The reductions in bacterial plaque were also similar (22.7% reduction in Group A, RRR=0.227; 28% reduction in Group B, RRR= 0.28). The number needed for treatment values for bleeding and plaque were A and B NNT=5 and A and B NNT=7, respectively. The rosemary-based toothpaste effectively treated gingival bleeding and reduced bacterial plaque, when compared with conventional toothpaste.

Application of Iced Normal Saline Combined with Cocktail Perfusion in Total Knee Arthroplasty:Randomized Controlled Trialrandomized Controlled Trial

2021 ◽  
Author(s):  
Laijian Sui ◽  
Aihua Jiang ◽  
Pengzhou Gai ◽  
Xiaojun Qi ◽  
Jinwei Wang ◽  
...  
Keyword(s):  
Normal Saline ◽  
Controlled Trial ◽  
Postoperative Recovery ◽  
Control Group ◽  
Double Blind ◽  
Vas Score ◽  
Postoperative Drainage ◽  
Group A ◽  
Total Knee ◽  
Group B

Abstract Background: The present study was designed to investigate the safety and effectiveness of iced normal saline combined with cocktail perfusion during total knee arthroplasty (TKA).Method: Sixty patients undergoing TKA were divided into three groups, then three different intro-operative articular cavity perfusion treatment was given according to the randomized, double-blind and controlled rule. One way ANOVA analysis on visual analogue scale (VAS) score, functional recovery, drainage, and edema of the affected limb were performed to assess the efficiency of the treatment in the following three days after the operation.Results: Postoperative drainage in group A and B reduced significantly (P<0.05). The IHC scores of the surgical limbs were markedly lower comparing with the control group (P<0.05). No differential postoperative edema was observed and the patient acquired better rehabilitation in group A and B than control group. Compared with group A, no differential postoperative drainage and edema was seen in group B (P>0.05). The VAS score of group B was significantly lower than in group A(P<0.05). Postoperative recovery of the surgical limb function in group B was better than in group A (P<0.05), and PGE2 in the postoperative drainage volume of group B was significantly decreased (P<0.05).Conclusions: Intra-operation articular cavity perfusion therapy with iced normal saline combined with cocktail perfusion therapy can greatly reduce the early inflammation, contributing to the better rehabilitation of TKA.

Efficacy and Safety of Traditional Chinese Medicine in COVID-2019: A Study Protocol for an Open-Label, Multicenter Randomized Controlled Trial

2020 ◽  
Author(s):  
Congcong Zeng ◽  
Zhengzhong Yuan ◽  
Xiaoqiong Pan ◽  
Jizhou Zhang ◽  
Jiahui Zhu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Outcome Measures ◽  
Lung Injury Score ◽  
Secondary Outcome ◽  
Control Group ◽  
Efficacy And Safety ◽  
Open Label ◽  
Randomized Controlled

Abstract Introduction: The outbreak of a novel coronavirus (SARS-CoV-2) and associated COVID-19 disease in late December 2019 has led to a global pandemic. It directly leads to high morbidity and mortality, but also results in a devastating effect on the global economy. Unfortunately, there are no effective therapies or vaccines for it. Hence, we designed a randomized trial to evaluate the efficacy and safety of Traditional Chinese Medicine for treating patients with COVID-19.Methods and analysis: This is an open-label, multicenter randomized controlled clinical trial. One hundred and twelve patients infected by SARS-CoV-2 will be randomly assigned to the experimental or the control group in an equal ratio. The patients in control group will accept routine supportive clinically care including the therapies of anti-viral, anti-bacterial and ameliorating the related symptoms, while patients in the experimental group will be asked to take traditional Chinese medicine depending on the different stages of the disease for consecutive 14 days in addition to supportive care. All data will be gathered at baseline and on days 3, 7, 10 and 14. The primary outcome measures will be the time of Reverse Transcription PCR testing of respiratory tract sample turns to be negative. Secondary outcome measures will include Murray lung injury score, MuLBSTA score and TCM ( Traditional Chinese Medicine ) Syndrome Scoring System. A laboratory test will be taken before and after treatment to assess the safety of TCM.Discussion: The study may help to identify the the efficacy and safety of Traditional Chinese Medicine in treating COVID-2019.Trial registration: Chinese Clinical Trial Registry, ChiCTR2000030759.Registered on March 13th 2020-Retrospectively registered, http://www.chictr.org.cn/.

Sign in / Sign up

Export Citation Format

Share Document